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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001714-14 | EudraCT Number | ||
| ALLEGRO 2B/3 | Other Identifier | Alias Study Number |
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This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks |
|
| Sequence B | Experimental | Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks |
|
| Sequence C | Experimental | Maintenance dose #1 given QD for 48 weeks |
|
| Sequence D | Experimental | Maintenance dose #2 given QD for 48 weeks |
|
| Sequence E | Experimental | Maintenance dose #3 given QD for 48 weeks |
|
| Sequence F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 Induction Dose | Drug | Oral tablets taken once daily (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham Hospital Outreach Lab | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41917311 | Derived | Senna M, Soung J, Figueras I, King B, Kinoshita-Ise M, Hanna S, Wu W, Wajsbrot D, Woodworth D, Wolk R, Chaudhry A, Lejeune A, Tran H. Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies. Am J Clin Dermatol. 2026 Mar 31. doi: 10.1007/s40257-026-01029-y. Online ahead of print. | |
| 41005700 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Total 1097 participants signed the informed consent form. Out of which 379 participants were screen failures, 718 actually enrolled into the study and were assigned to study treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe alopecia areata (AA) with greater than or equal to (>=) 50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 milligram (mg) tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (up to Week 24) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2021 | Dec 16, 2021 |
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Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks |
|
| Sequence G | Experimental | Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks |
|
| PF-06651600 Maintenance Dose #1 | Drug | Oral tablets taken QD |
|
| PF-06651600 Maintenance Dose #2 | Drug | Oral tablets taken QD |
|
| PF-06651600 Maintenance Dose #3 | Drug | Oral tablets taken QD |
|
| Placebo | Drug | Oral tablets taken QD |
|
| Week 24 |
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported. | Week 24 |
| Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 | PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. | Week 24 |
| Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model | The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | Week 24 |
| Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model | The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | Week 24 |
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | Week 4, 8, 12, 18, 28, 34, 40, and 48 |
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported. | Week 4, 8, 12, 18, 28, 34, 40, and 48 |
| Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score. | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
| Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 4, 8, 12, 18, and 24 |
| Change From Baseline in SALT Score at Week 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 28, 34, 40, and 48 |
| Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows. | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
| Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash. | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
| Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 | PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. | Week 4, 8, 12, 18, 24, 34, 40, and 48 |
| Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations | AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 4, 8, 12, 18, and 24 |
| Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations | AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 34, 40, and 48 |
| Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 | AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss. | Week 4, 8, 12, 18, 24, 34, 40, and 48 |
| Baseline (Day 1), Week 4, 8, 12, and 24 |
| Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 48 |
| Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 4, 8, 12, and 24 |
| Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. | Baseline (Day 1), Week 48 |
| Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. | Week 4, 8, 12, 24 and 48 |
| Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 | HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. | Week 4, 8, 12, 24 and 48 |
| The University of Alabama at Birmingham, Department of Dermatology |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| The University of Alabama at Birmingham, Department of Dermatology | Birmingham | Alabama | 35294 | United States |
| Mosaic Dermatology | Beverly Hills | California | 90211 | United States |
| University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center | Irvine | California | 92697 | United States |
| Dermatology Specialists, Inc. | Murrieta | California | 92562 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente Clinical Trials Unit | San Francisco | California | 94118 | United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital Clinical and Translational Research Center | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital Outpatient Pavillion | Aurora | Colorado | 80045 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| Church Street Research Unit | New Haven | Connecticut | 06519 | United States |
| Medstar Georgetown University Hospital Center-Department of Otolaryngology | Washington D.C. | District of Columbia | 20007 | United States |
| Medstar Washington Hospital Center-Claude Nogay Research Pharmacy | Washington D.C. | District of Columbia | 20010 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Medstar Georgetown University Hospital Center-Department of Pediatrics | Washington D.C. | District of Columbia | 20016 | United States |
| Siperstein Dermatology Group | Boynton Beach | Florida | 33472 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Northwestern Medical Group | Chicago | Illinois | 60611 | United States |
| Northwestern Medicine Diagnostic Testing Center | Chicago | Illinois | 60611 | United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital, Investigational Research Pharmacy | Chicago | Illinois | 60611 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS; | Iowa City | Iowa | 52242 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Medstar Georgetown University Hospital - Department of Dermatology | Chevy Chase | Maryland | 20815 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota Department of Dermatology | Minneapolis | Minnesota | 55455 | United States |
| University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke | Minneapolis | Minnesota | 55455 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | United States |
| NYU School of Medicine, The Ronald O. Perelman Department of Dermatology | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| UNC CTRC | Chapel Hill | North Carolina | 27514 | United States |
| UNC Hospitals, Investigational Drug Service | Chapel Hill | North Carolina | 27514 | United States |
| UNC Dermatology Clinical Trials Unit | Chapel Hill | North Carolina | 27516 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Vital Prospects Clinical Research Institute, P.C | Tulsa | Oklahoma | 74136 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| CINME Centro de Investigaciones Metabolicas | CABA | Buenos Aires | C1027AAP | Argentina |
| Psoriahue Medicina Interdisciplinaria | CABA | C1425DKG | Argentina |
| Premier Specialists Pty Ltd | Kogarah | New South Wales | 2217 | Australia |
| St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| Skin Health Institute | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Royal Park Campus | Parkville | Victoria | 3052 | Australia |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Eastern Canada Cutaneous Research Associates Ltd. | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| Medicor Research Inc | Greater Sudbury | Ontario | P3A1W8 | Canada |
| Sudbury Skin Clinique | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Guenther Research Inc | London | Ontario | N6A 3H7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X3 | Canada |
| The Centre for Clinical Trials | Oakville | Ontario | L6J 7W5 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| York Dermatology Clinic and Research Centre | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Centro Internacional de Estudios Clinicos, CIEC | Santiago | Recoleta | 8420383 | Chile |
| Centro Medico Skin Med | Santiago | Santiago Metropolitan | 7580206 | Chile |
| Clinica Dermacross S.A. | Santiago | Santiago Metropolitan | 7640881 | Chile |
| Medical Skin Center | Viña del Mar | Valparaiso | 2530900 | Chile |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | 518053 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Huashan Hospital, Fudan University/Dermatology Department | Shanghai | Shanghai Municipality | 200040 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept | Hangzhou | Zhejiang | 310009 | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Fundacion Centro de Investigacion Clinica CIC | MedellÃn | Antioquia | 050001 | Colombia |
| Fundacion Hospitalaria San Vicente de Paul | MedellÃn | Antioquia | 050010 | Colombia |
| Centro de Investigación en ReumatologÃa y Especialidades Médicas SAS - CIREEM SAS | Bogotá | D.C. | 110221 | Colombia |
| DERMAMEDICA s.r.o. | Náchod | 54701 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Clintrial s.r.o. | Prague | 100 00 | Czechia |
| Sanatorium profesora Arenbergera | Prague | 11000 | Czechia |
| Nemocnice Na Bulovce | Praha 8- Liben | 180 81 | Czechia |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Emovis GmbH | Berlin | 10629 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91054 | Germany |
| University Hospital Frankfurt | Frankfurt am Main | 60590 | Germany |
| University Hospital Schleswig-Holstein | Lübeck | 23538 | Germany |
| University Hospital Muenster | Münster | 48149 | Germany |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Debreceni Egyetem | Debrecen | 4032 | Hungary |
| Bugat Pal Korhaz, Borgyogyaszat | Gyöngyös | 3200 | Hungary |
| Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar | Szeged | 6720 | Hungary |
| Nagoya City University Hospital - Dermatology | Nagoya | Aichi-ken | 467-8602 | Japan |
| Tohoku University hospital | Sendai | Miyagi | 980-8574 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Juntendo Tokyo Koto Geriatric Medical Center | Koto-ku | Tokyo | 136-0075 | Japan |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Osaka City University Hospital | Osaka | 545-8586 | Japan |
| Sociedad de Metabolismo y Corazon S.C. | Veracruz | C.P. 91900 | Mexico |
| Hospital D'Maria | Veracruz | CP. 91910 | Mexico |
| Centermed Krakow Sp.z o.o. | Krakow | 31-530 | Poland |
| Medicover Sp.z.o.o | Lodz | 90-368 | Poland |
| Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak | Lodz | 90-436 | Poland |
| Sanova Audiological Care Polska Sp.z.o.o | Lodz | 91-867 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| RCMed Oddzial Warszawa | Warsaw | 02-657 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | 02-962 | Poland |
| Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska | Wroclaw | 50-566 | Poland |
| State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary | Chelyabinsk | 454092 | Russia |
| University Clinic of Kirov SMU | Kirov | 610035 | Russia |
| Clinical Medical Center of A.I. Yevdokimov MSMSU | Moscow | 111398 | Russia |
| Federal State Autonomous Institution National Medical Research Centre of Childrens Health | Moscow | 119991 | Russia |
| State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary" | Rostov-on-Don | 344002 | Russia |
| Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC) | Saint Petersburg | 191123 | Russia |
| Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic" | Saint Petersburg | 191123 | Russia |
| Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 - | Saint Petersburg | 194021 | Russia |
| State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital | Yaroslavl | 150003 | Russia |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Reina SofÃa, Servicio Dermatologia | Córdoba | 14004 | Spain |
| Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Servicio Radiologia, Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe | Valencia | 46026 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch | Kaohsiung City | 83301 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| Chung-Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Chang Gung Memorial Hospital-Linkou Branch | Taoyuan City | 333 | Taiwan |
| Brighton and Sussex University Hospitals NHS Trust | Brighton | EAST Sussex | BN2 5BE | United Kingdom |
| Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital | Southampton | Hampshire | SO14 0YG | United Kingdom |
| Brighton and Sussex University Hospitals NHS Trust | Brighton | BN2 5BE | United Kingdom |
| NHS Tayside Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G51 4TF | United Kingdom |
| Southampton University Hospital NHS Foundation Trust, University Hospital Southampton | Hampshire | SO16 6YD | United Kingdom |
| Harley Grove Medical Centre | London | E3 2AT | United Kingdom |
| Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital, | London | SE1 7EH | United Kingdom |
| Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital, | London | SE1 9RT | United Kingdom |
| Derived |
| Mauer J, Whichello C, Hauber B, Krucien N, Law EH, Trapali M, Senna M, Zwillich SH, Wolk R, Tervonen T. A Patient Preference-Weighted Quantitative Benefit-Risk Analysis of Ritlecitinib for Alopecia Areata to Inform Medical Decision Making. Value Health. 2026 Feb;29(2):277-284. doi: 10.1016/j.jval.2025.09.007. Epub 2025 Sep 24. |
| 40261547 | Derived | Mostaghimi A, Gibson A, Dwyer G, Oluboyede Y, Mazar I, Gorbatenko-Roth K, Law E. Exploring Factors That Influence the Measurement of Patient-Reported Impacts of Alopecia Areata. Dermatol Ther (Heidelb). 2025 Jun;15(6):1391-1403. doi: 10.1007/s13555-025-01400-7. Epub 2025 Apr 22. |
| 39962358 | Derived | King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards RA, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich SH, Lejeune A. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17. |
| 39441519 | Derived | Sinclair R, Mesinkovska N, Mitra D, Wajsbrot D, Law EH, Wolk R, King B. Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial. Am J Clin Dermatol. 2025 Jan;26(1):109-119. doi: 10.1007/s40257-024-00899-4. Epub 2024 Oct 23. |
| 39328096 | Derived | Mesinkovska N, King B, Zhang X, Guttman-Yassky E, Magnolo N, Sinclair R, Mizuashi M, Shapiro J, Peeva E, Banerjee A, Takiya L, Cox LA, Wajsbrot D, Kerkmann U, Law E, Wolk R, Schaefer G. Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis. J Dermatol. 2024 Nov;51(11):1414-1424. doi: 10.1111/1346-8138.17442. Epub 2024 Sep 27. |
| 39254890 | Derived | Fu J, Egeberg A, Holmes S, Vano-Galvan S, Steinhoff M, Edwards R, Bonfanti G, Nagra R, Wolk R, Tran H, Law E. Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2759-2769. doi: 10.1007/s13555-024-01260-7. Epub 2024 Sep 10. |
| 38263353 | Derived | King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23. |
| 37917289 | Derived | Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2. |
| 37707764 | Derived | Thaci D, Tziotzios C, Ito T, Ko J, Karadag AS, Fang H, Edwards RA, Bonfanti G, Wolk R, Tran H, Law E. Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Dermatol Ther (Heidelb). 2023 Nov;13(11):2621-2634. doi: 10.1007/s13555-023-00997-x. Epub 2023 Sep 14. |
| 37403610 | Derived | King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. A plain language summary on ritlecitinib treatment for adults and adolescents with alopecia areata. Immunotherapy. 2023 Oct;15(14):1093-1103. doi: 10.2217/imt-2023-0069. Epub 2023 Jul 5. |
| 37062298 | Derived | King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2. Epub 2023 Apr 14. |
| FG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| FG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| FG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| FG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| FG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| FG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Extension (Week 25 up to 48) |
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Full analysis set (FAS) included all participants who were randomized, regardless of whether they received study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . |
| BG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported. | FAS included all participants who were randomized, regardless of whether they received study medication. Participants with missing SALT scores due to coronavirus disease-19 related reasons were excluded from this analysis, while participants with missing data due to other reasons were considered as non-responders. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported. | FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 4: Data imputed by using a missing at random (MAR) mechanism for participants with missing data due to COVID-19. Missing data due to reasons not related to COVID-19 were consider as non-responders. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported. | FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 1: Participants with missing SALT score at Week 24 due to COVID-19 related reasons excluded from analysis at that time point, participants with missing SALT scores due to other reasons counted as non-responders at that time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 | PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model | The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | FAS included all participants who were randomized, regardless of whether they received study medication. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model | The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 28, 34, 40, and 48 |
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| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 28, 34, 40, and 48 |
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| Secondary | Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
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| Secondary | Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 1), Week 4, 8, 12, 18, and 24 |
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| Secondary | Change From Baseline in SALT Score at Week 28, 34, 40, and 48 | SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1), Week 28, 34, 40, and 48 |
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| Secondary | Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
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| Secondary | Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
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| Secondary | Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 | PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | Percentage of participants | Week 4, 8, 12, 18, 24, 34, 40, and 48 |
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| Secondary | Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations | AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 1), Week 4, 8, 12, 18, and 24 |
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| Secondary | Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations | AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1), Week 34, 40, and 48 |
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| Secondary | Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 | AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specified time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 18, 24, 34, 40, and 48 |
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| Other Pre-specified | Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 1), Week 4, 8, 12, and 24 |
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| Other Pre-specified | Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1), Week 48 |
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| Other Pre-specified | Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "number analyzed" signifies participants evaluable at specific time point. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 1), Week 4, 8, 12, and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 1), Week 48 |
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| Other Pre-specified | Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 | HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 24 and 48 |
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| Other Pre-specified | Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 | HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. | FAS included all participants who were randomized, regardless of whether they received study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4, 8, 12, 24 and 48 |
|
Baseline up to 5 weeks after last dose of study drug (maximum up to Week 53)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 50 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug . | 0 | 131 | 4 | 131 | 84 | 131 |
| EG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 129 | 2 | 129 | 76 | 129 |
| EG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 130 | 2 | 130 | 81 | 130 |
| EG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 132 | 1 | 132 | 77 | 132 |
| EG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 62 | 2 | 62 | 32 | 62 |
| EG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 65 | 0 | 65 | 39 | 65 |
| EG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. | 0 | 66 | 3 | 66 | 39 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v24.0 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2021 | Dec 16, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| C537055 | Alopecia universalis |
| D006201 | Hair Diseases |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Non-Compliant with study drug |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Estimate of difference |
| 20.78 |
| 2-Sided |
| 95 |
| 13.65 |
| 29.18 |
| Superiority |
| Miettinen and Nurminen method | <0.000001 | Estimate of difference | 21.85 | 2-Sided | 95 | 14.65 | 30.23 | Superiority |
| Miettinen and Nurminen method | 0.000154 | Estimate of difference | 12.75 | 2-Sided | 95 | 6.69 | 20.36 | Superiority |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
|
|
|
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
|
|
|
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
|
|
|
| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
|
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug.
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo | Participants aged 12 years or above with moderate to severe AA with>=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received either 4 of 50 mg tablet once daily for 4 weeks followed by 50 mg tablet once daily for next 20 weeks or 50 mg tablet once daily for next 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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| OG001 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 4 of 50 mg tablet once daily for 4 weeks (loading phase) and then 3 of 10 mg tablet once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and continued to receive 3 of 10 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG002 | Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 50 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 50 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG003 | Ritlecitinib (PF-06651600) 30 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 3 of 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 3 of 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG004 | Ritlecitinib (PF-06651600) 10 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive Ritlecitinib 10 mg tablet once daily for 4 weeks (loading phase). Participants then continued to receive 10 mg tablet once daily in maintenance phase of 20 weeks and extension phase of 24 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG005 | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 4 of 50 mg tablet once daily for 4 weeks and then 50 mg tablet once daily for 20 weeks. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
| OG006 | Placebo, Ritlecitinib (PF-06651600) 50 mg | Participants aged 12 years or above with moderate to severe AA with >=50% hair loss of the scalp were randomized to receive placebo once daily for 4 weeks (loading phase) and then continued to receive placebo once daily for next 20 weeks (maintenance phase). Participants then entered into extension phase of 24 weeks and received 50 mg tablet once daily. Participants were followed up to maximum of 5 weeks after the last dose of study drug. |
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