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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003051-38 | EudraCT Number |
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This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle cream QD | Placebo Comparator | Vehicle cream applied once daily (QD) |
|
| PF-06700841 0.1% cream QD | Experimental | PF-06700841 0.1% cream applied once daily (QD) |
|
| PF-06700841 0.3% cream QD | Experimental | PF-06700841 0.3% cream applied once daily (QD) |
|
| PF-06700841 1% cream QD | Experimental | PF-06700841 1% cream applied once daily (QD) |
|
| PF-06700841 3% cream QD | Experimental | PF-06700841 3% cream applied once daily (QD) |
|
| PF-06700841 0.3% cream BID | Experimental | PF-06700841 0.3% cream applied twice daily (BID) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 | Drug | PF-06700841 topical cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 | PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity. |
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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 |
|---|---|---|---|---|---|---|
| Center for Dermatology and Plastic Surgery/CCT | Scottsdale | Arizona | 85260 | United States | ||
| Center for Dermatology and Plastic Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32311398 | Background | Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18. | |
| 39160651 |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1: Vehicle Once Daily (QD) | During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG001 | Stage 1: PF-06700841 0.1% QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment for Stage 1 |
|
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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 20, 2020 | Apr 7, 2022 |
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| PF-06700841 1% cream BID | Experimental | PF-06700841 1% cream applied twice daily (BID) |
|
| Vehicle cream BID | Placebo Comparator | Vehicle cream applied twice daily (BID) |
|
| PF-06700841 3% cream BID | Experimental | PF-06700841 3% cream applied twice daily (BID) |
|
| Vehicle (Placebo) | Drug | Vehicle topical cream |
|
| Baseline, Week 12 |
| Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
| Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Change From Baseline in PASI Scores at Week 14 and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 14 and 16 |
| Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Percent Change From Baseline in PASI Scores at Week 14 and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Baseline, Week 14 and 16 |
| Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Absolute PP-NRS Score at Week 14 and 16 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | Week 14 and 16 |
| Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Change From Baseline in PP-NRS Score at Week 14 and 16 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | Baseline, Week 14 and 16 |
| Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) |
| Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) |
| Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16 | PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity. | Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16 |
| Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
| Number of Participants With TEAEs by Severity | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event). | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
| Number of Participants Who Discontinued From Study Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
| Number of Participants With Laboratory Abnormalities Meeting Specified Criteria | Bilirubin: greater than (>) 1.5* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: >2.5*ULN; creatinine, cystatin C: >1.3*ULN; creatine kinase: >2.0*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (<) 60 milliliter (mL)/minute (min)/1.73 meter(m)^2, greater than or equal to (>=) 30% decrease from baseline; GFR: <60 mL/min/1.73m^2. | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
| Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data | Following were ECG criteria used for categorical summary:1) PR interval: percentage change >=25/50%, QRS interval: value >140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec < value less than equal to (<=) 480 and 30 < change <=60. | Post-baseline to Week 6, Post-baseline to Week 12 |
| Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data | Following were the vital signs criteria: 1) Pulse rate: value <40 beats per min (bpm), value >120 bpm; 2) Sitting diastolic blood pressure (DBP): value <50 mmHg; change >=20 mmHg increase; change >=20 mmHg decrease; 3) Sitting systolic blood pressure (SBP): value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease; 4) Supine DBP: value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; 5) Supine SBP: value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease. | Post-baseline to Week 12 |
| Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 | At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). | Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
| California Skin Institute | Anaheim | California | 92801 | United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| New England Research Associates, LLC | Bridgeport | Connecticut | 06606 | United States |
| Dermatology Physicians of Connecticut | Shelton | Connecticut | 06484 | United States |
| Olympian Clinical Research | Clearwater | Florida | 33756 | United States |
| Accel Research Sites - DeLand Clinical Research Unit | DeLand | Florida | 32720 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| MidState Skin Institute | Ocala | Florida | 34471 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Park Avenue Dermatology, PA | Orange Park | Florida | 32073 | United States |
| Center for Clinical Studies | Tampa | Florida | 33613 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Ds Research | Clarksville | Indiana | 47129 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Bayside Dermatology Center | Bayside | New York | 11360 | United States |
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Rivergate Dermatology Clinical Research | Goodlettsville | Tennessee | 37072 | United States |
| Austin Institute for Clinical Research, Inc. | Austin | Texas | 78705 | United States |
| studies in Dermatology, LLC | Cypress | Texas | 77433 | United States |
| Center for Clinical Studies, LTD. LLP | Houston | Texas | 77004 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Summit Clinical Research, LLC | Franklin | Virginia | 23851 | United States |
| Virginia Dermatology and Skin Cancer Center | Norfolk | Virginia | 23502 | United States |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Center for Skin and Venereal Diseases EOOD - Sofia | Sofia | 1404 | Bulgaria |
| DCC Alexandrovska | Sofia | 1431 | Bulgaria |
| Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD | Sofia | 1463 | Bulgaria |
| Dermatological Clinic Sofia | Sofia | 1756 | Bulgaria |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| SKiN Health | Cobourg | Ontario | K9A 4J9 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Emovis GmbH | Berlin | 10629 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| ISA - Interdisciplinary Study Association GmbH | Berlin | 10789 | Germany |
| Klinikum Bielefeld gem.GmbH | Bielefeld | 33647 | Germany |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | 01307 | Germany |
| MENSINGDERMA research GmbH | Hamburg | 22391 | Germany |
| MVZ Alstermed GmbH | Hamburg | 22391 | Germany |
| Dermatologische Gemeinschaftspraxis | Mahlow | 15831 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| Semmelweis Egyetem Altalanos Orvostudomanyi Kar | Budapest | 1085 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza | Kecskemét | 6000 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6720 | Hungary |
| Kitago Dermatology Clinic | Sapporo | Hokkaido | 003-0833 | Japan |
| Nakatsuhifuka Clinic | Kita-ku, Osaka-shi | Osaka | 531-0072 | Japan |
| Parkside Hiroo Ladies Clinic | Minato-ku | Tokyo | 106-0047 | Japan |
| Tanpopo Skin Clinic | ÅŒta-ku | Tokyo | 143-0023 | Japan |
| Samoncho Dermatological Clinic | Shinjuku-ku | Tokyo | 160-0017 | Japan |
| Medical Corporation Jitai-kai Tachikawa Dermatology Clinic | Tachikawa | Tokyo | 190-0023 | Japan |
| Riga 1st Hospital | Riga | LV-1001 | Latvia |
| Aesthetic dermatology clinic of Prof. J. Kisis | Riga | LV-1003 | Latvia |
| Health and Aesthetics Ltd | Riga | LV-1009 | Latvia |
| Outpatient Clinic of Ventspils | Ventspils | LV3601 | Latvia |
| Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik | Bialystok | 15-351 | Poland |
| Nasz Lekarz Przychodnie Medyczne | Torun | 87-100 | Poland |
| MTZ Clinical Research Sp. z o.o | Warsaw | 02-106 | Poland |
| WroMedica I. Bielicka, A. Strzalkowska s.c. | Wroclaw | 51-685 | Poland |
| Draelos ZD, Bushmakin AG, Ghosh P, Xenakis J, Cappelleri JC. Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study. Int J Dermatol. 2024 Dec;63(12):e375-e382. doi: 10.1111/ijd.17428. Epub 2024 Aug 19. |
During stage 1 of the study participants topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG002 | Stage 1: PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG003 | Stage 1: PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG004 | Stage 1: PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG005 | Stage 1: Vehicle Twice Daily (BID) | During stage 1 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG006 | Stage 1: PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG007 | Stage 1: PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG008 | Stage 2: Vehicle BID | During stage 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| FG009 | Stage 2: PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up for Stage 1 |
|
|
| Treatment for Stage 2 |
|
|
| Follow-up For Stage 2 |
|
|
Analysis population included participants who were randomly assigned to PF-06700841 and applied at least 1 dose of PF-06700841.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Once Daily (QD) | During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG001 | PF-06700841 0.1% QD | During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | The Psoriasis Area and Severity Index (PASI) score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected body surface area (BSA) from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | Efficacy analysis set (EAS) included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Week 12 |
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| Secondary | Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 | PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline, Week 12 |
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| Secondary | Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
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| Secondary | Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
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| Secondary | Change From Baseline in PASI Scores at Week 14 and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 14 and 16 |
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| Secondary | Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
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| Secondary | Percent Change From Baseline in PASI Scores at Week 14 and 16 | The PASI score (0-72, with higher score representing greater severity) is a measurement of the severity and extent of psoriasis. The four regions of the body parts are head (10%), arms (20%), trunk (30%) and legs (40%). In each region, the area is expressed as a score of 0 (nothing), 1 (1-9%), 2 (10-29%), 3 (30-49%), 4 (50-69%), 5 (70-89%) or 6 (90-100%). Within each area, the degree of severity for erythema, induration and scaling are estimated between 0 and 4, with 4 being the highest severity. The final score combines disease severity and effected BSA from for four regions using the formula PASI =0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl) where A = Area Score; E = erythema; I =induration; S = scaling; h = head; u = upper limbs; t = trunk; l = lower limbs. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 14 and 16 |
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| Secondary | Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
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| Secondary | Absolute PP-NRS Score at Week 14 and 16 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | Week 14 and 16 |
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| Secondary | Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
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| Secondary | Change From Baseline in PP-NRS Score at Week 14 and 16 | Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 14 and 16 |
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| Secondary | Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) |
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| Secondary | Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET) |
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| Secondary | Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16 | PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, "number analyzed" signifies the number of participants evaluable at specified time points. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16 |
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| Secondary | Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 | PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. | EAS included all randomized participants who receive at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Number | 90% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Safety analysis set (SAS) included participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
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| Secondary | Number of Participants With TEAEs by Severity | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event). | SAS included participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
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| Secondary | Number of Participants Who Discontinued From Study Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. | SAS included participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
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| Secondary | Number of Participants With Laboratory Abnormalities Meeting Specified Criteria | Bilirubin: greater than (>) 1.5* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: >2.5*ULN; creatinine, cystatin C: >1.3*ULN; creatine kinase: >2.0*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (<) 60 milliliter (mL)/minute (min)/1.73 meter(m)^2, greater than or equal to (>=) 30% decrease from baseline; GFR: <60 mL/min/1.73m^2. | SAS included participants who received at least 1 dose of investigational product. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks) |
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| Secondary | Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data | Following were ECG criteria used for categorical summary:1) PR interval: percentage change >=25/50%, QRS interval: value >140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec < value less than equal to (<=) 480 and 30 < change <=60. | SAS included participants who receive at least 1 dose of investigational product | Posted | Count of Participants | Participants | Post-baseline to Week 6, Post-baseline to Week 12 |
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| Secondary | Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data | Following were the vital signs criteria: 1) Pulse rate: value <40 beats per min (bpm), value >120 bpm; 2) Sitting diastolic blood pressure (DBP): value <50 mmHg; change >=20 mmHg increase; change >=20 mmHg decrease; 3) Sitting systolic blood pressure (SBP): value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease; 4) Supine DBP: value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; 5) Supine SBP: value <90 mmHg, change >=30 mmHg increase, change >=30 mmHg decrease. | SAS included participants who receive at least 1 dose of investigational product. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure and 'number analyzed' signifies number of participants evaluable at specified time points. | Posted | Count of Participants | Participants | Post-baseline to Week 12 |
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| Secondary | Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 | At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). | SAS included participants who receive at least 1 dose of investigational product. Here, "number analyzed" signifies the number of participants evaluable at specified time points. | Posted | Count of Participants | Participants | Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 |
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Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)
Same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. SAS included participants who received at least 1 dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Vehicle Once Daily (QD) | During stage 1 of the study participants topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 37 | 1 | 37 | 7 | 37 |
| EG001 | PF-06700841 0.1% QD | During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 37 | 0 | 37 | 7 | 37 |
| EG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 37 | 0 | 37 | 7 | 37 |
| EG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 36 | 1 | 36 | 9 | 36 |
| EG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 37 | 0 | 37 | 8 | 37 |
| EG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 1 | 49 | 1 | 49 | 10 | 49 |
| EG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 36 | 1 | 36 | 4 | 36 |
| EG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 36 | 2 | 36 | 10 | 36 |
| EG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. | 0 | 38 | 0 | 38 | 2 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary failure | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Aspiration bursa | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular 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 the 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 | May 4, 2021 | Apr 7, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630838 | PF-06700841 |
Not provided
Not provided
Not provided
| Physician Decision |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Refused Further Study Procedures |
|
| Other |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| No Longer Meets Eligibility Criteria |
|
| Refused Further Treatment |
|
| 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 |
|
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| ANCOVA |
| 0.6100 |
Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. |
| LS mean difference |
| 0.2 |
| Standard Error of the Mean |
| 0.65 |
| 2-Sided |
| 90 |
| -0.89 |
| 1.26 |
| Superiority |
| ANCOVA | 0.1686 | Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. | LS mean difference | -0.6 | Standard Error of the Mean | 0.65 | 2-Sided | 90 | -1.70 | 0.45 | Superiority |
| ANCOVA | 0.1051 | Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. | LS mean difference | -0.8 | Standard Error of the Mean | 0.64 | 2-Sided | 90 | -1.87 | 0.25 | Superiority |
| ANCOVA | 0.3583 | Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. | LS mean difference | -0.2 | Standard Error of the Mean | 0.68 | 2-Sided | 90 | -1.37 | 0.88 | Superiority |
| ANCOVA | 0.1131 | Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. | LS mean difference | -0.8 | Standard Error of the Mean | 0.66 | 2-Sided | 90 | -1.88 | 0.29 | Superiority |
| ANCOVA | 0.1812 | Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level. | LS mean difference | -0.6 | Standard Error of the Mean | 0.64 | 2-Sided | 90 | -1.64 | 0.47 | Superiority |
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
| OG001 | PF-06700841 0.1% QD | During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
| PF-06700841 0.1% QD |
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG001 |
| PF-06700841 0.1% QD |
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
|
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
|
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
|
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| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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During stage 1 of the study participants topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose.
| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| OG003 |
| PF-06700841 1.0% QD |
During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| PF-06700841 0.3% QD |
During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| OG002 | PF-06700841 0.3% QD | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG003 | PF-06700841 1.0% QD | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG004 | PF-06700841 3.0% QD | During stage 1 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG005 | Pooled Vehicle BID | During stage 1 and 2 of the study participants topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG006 | PF-06700841 0.3% BID | During stage 1 of the study participants topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG007 | PF-06700841 1.0% BID | During stage 1 of the study participants topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
| OG008 | PF-06700841 3.0% BID | During stage 2 of the study participants topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Participants were followed up for 4 weeks after last dose. |
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| Mild |
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| Moderate |
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| Severe |
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| Very severe |
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| Missing |
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