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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515438-33-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.
This study is seeking participants who have:
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken once each day at home.
The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.
Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to <12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes.
This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower doses) and 1 placebo arm. The participants will be assessed for study eligibility at the screening visit after informed consent/assent is obtained (as applicable).
Participants will receive study medication for a duration of 24 weeks.
At least 225 participants will be enrolled in the study. At least 30% of total study population will be recruited from Europe.
The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Alopecia Areata Patient Priority Outcomes (AAPPO), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study. Pharmacokinetics of ritlecitinib will be evaluated using sparse sampling.
Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.
Participants completing the 24-week treatment period of the study may have the option to enter the long-term extension (LTE) Study B7981028, if the eligibility criteria are met. Participants who complete the 24-week treatment period of the study but who are ineligible for the LTE study will undergo a 4-week off-treatment follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritlecitinib higher dose | Experimental | Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks. |
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| Ritlecitinib lower dose | Experimental | Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib higher dose | Drug | Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. | The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
| For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10. | The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". | The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
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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 |
|---|---|---|---|---|---|---|
| UCI Dermatology Clinical Research | Irvine | California | 92697 | United States | ||
| Southern California Clinical Research |
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| 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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Participants and their caregivers, Investigators and other site staff will be blinded to their assigned study intervention. Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention and the provision noted below.
Sponsor staff who are not directly involved with the conduct of this study will prepare analyses and documentation containing unblinded data while the study is ongoing
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| Ritlecitinib lower dose | Drug | Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
|
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| Placebo | Drug | Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
|
| For all countries: Change from baseline (CFB) in SALT score. | The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint). | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18 |
| For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint). | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18. |
| For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint). | The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18. |
| For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)). | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline. | The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline. | The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: Plasma concentration of ritlecitinib. | Post dose hour 1 and hour 3 at day 28 or day 56. |
| For all countries: Incidence of treatment emergent Adverse Events (AEs). | To evaluate safety and tolerability of ritlecitinib over time. | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). |
| For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. | To evaluate safety and tolerability of ritlecitinib over time. | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). |
| CFB in AAPPO activity limitation score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| For all countries: Acceptability and palatability assessment. | To evaluate acceptability and palatability of the age-appropriate formulation. | Week 2 and Week 18 |
| CFB in AAPPO emotional symptoms score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
| Santa Ana |
| California |
| 92701 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Pediatric Skin Research | Miami | Florida | 33156 | United States |
| Endeavor Health Clinical Operations | Evanston | Illinois | 60201 | United States |
| Endeavor Health Clinical Operations | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Kindred Hair and Skin Center | Marriottsville | Maryland | 21104 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | United States |
| Ear, Nose and Throat Consultants, LLC | Omaha | Nebraska | 68144 | United States |
| Skin Specialists, PC dba Schlessinger MD | Omaha | Nebraska | 68144 | United States |
| Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist) | Papillion | Nebraska | 68046 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico-IDS Pharmacy | Albuquerque | New Mexico | 87106 | United States |
| Regents of the University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Northwest Dermatology Institute | Portland | Oregon | 97210 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina Department of Dermatology and Dermatologic Surgery | Charleston | South Carolina | 29425 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dell Children's Medical Center | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| 3A Research - West Location | El Paso | Texas | 79902 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Beijing Children's hospital, Capital Medical University | Beijing | Beijing Municipality | 100045 | China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100192 | China |
| Beijing Tongren Hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| The Second Affiliated Hospital Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510140 | China |
| Hunan Children's Hospital | Changsha | Hunan | 410007 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Chengdu Women and Children Center Hospital | Chengdu | Sichuan | 610091 | China |
| Kunming Children's hospital | Kunming | Yunnan | 650103 | China |
| The First People's Hospital of Hangzhou | Hangzhou | Zhejiang | 310006 | China |
| Hangzhou Third Hospital | Hangzhou | Zhejiang | 310009 | China |
| China-Japan Friendship Hospital | Beijing | 100029 | China |
| Shanghai Children's Hospital | Shanghai | 200062 | China |
| Fakultní Nemocnice Brno | Brno | 613 00 | Czechia |
| Fakultní nemocnice Plzeň | Pilsen | 30599 | Czechia |
| Prof. MUDr. Petr Arenberger, DrSc., MBA | Prague | 11000 | Czechia |
| Fakultní nemocnice Bulovka | Praha 8 - Libeň | 180 81 | Czechia |
| Hospices Civils de Lyon - CIC - Hopital Louis Pradel | Bron | 69500 | France |
| Hospices Civils de Lyon - Hopital Femme Mere Enfant | Bron | 69500 | France |
| CHU de Dijon Bourgogne | Dijon | 21079 | France |
| GHICL - Service d'investigation - Recherche clinique | Lille | 59000 | France |
| GHICL - Hôpital Saint Vincent de Paul | Lille | 59020 | France |
| Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 | Nice | 06200 | France |
| Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey | Toulouse | 31400 | France |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
| Asst Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Policlinico "G. Rodolico | Catania | 95123 | Italy |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | Niigata | 951-8520 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Kyorin University Hospital | Mitaka | Tokyo | 181-8611 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8586 | Japan |
| Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c. | Krakow | Lesser Poland Voivodeship | 30-002 | Poland |
| Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| DERMEDIC Iwona Zdybska | Lublin | Lublin Voivodeship | 20-607 | Poland |
| Klinika Osipowicz & Turkowski | Warsaw | Masovian Voivodeship | 00-716 | Poland |
| Państwowy Instytut Medyczny MSWiA | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Provita Poliklinika | Warsaw | Masovian Voivodeship | 02-647 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal" | Bialystok | Podlaskie Voivodeship | 15-453 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Provita Sp. z o.o. | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Labderm Essence Sp. Z o.o. | Ossy | Silesian Voivodeship | 42-624 | Poland |
| Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie | Rzeszów | 35-055 | Poland |
| Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak | Lodz | Łódź Voivodeship | 90-436 | Poland |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Royal Alexandra Children's Hospital | Brighton | EAST Sussex | BN2 5BE | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | Greater London | SE1 7EH | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | London | Greater London | SW10 9NH | United Kingdom |
| Great Ormond Street Hospital For Children NHS Foundation Trust | London | Greater London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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