A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
Condition(s) studied
Investigational drug(s) / intervention(s)
Ritlecitinib 100 mg: 100 mg Capsule
Ritlecitinib 50 mg: 50 mg Capsule
Placebo - 100 mg: Capsule (to match Ritlecitinib 100 mg)
Placebo - 50 mg: Capsule (to match Ritlecitinib 50 mg)
Study summary
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.
Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.
This study is seeking participants who:
* Are 12 years of age or older (Part 1)
* Are 12 to less than 18 years (Part 2)
* Have a diagnosis of alopecia areata
* Have lost 50% or more of the hair on their scalp
* Do not have any other conditions that causes hair loss
* Are willing to stop all other treatments that they may be taking for alopecia areata
About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study.
In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.
The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.
In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata.
People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:
* alopecia areata assessment,
* physical examinations,
* hearing tests,
* blood tests,
* x-ray,
* ECG (electrocardiogram),
* photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.
Eligibility
Primary outcome measure(s)
- Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20 — Week 24
Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo - Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation — Baseline to Follow-up visit (Week 52)
Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD - Part 2: Percentage of participants with clinically significant laboratory abnormalities — Baseline to Follow-up visit (Week 52)
Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD
Trial sites (146)
| Facility | City | Region | Status |
|---|---|---|---|
| The Kirklin Clinic of UAB Hospital (Radiology) | Birmingham | Alabama | Recruiting |
| University of Alabama at Birmingham Faculty Office Towers (Regulatory) | Birmingham | Alabama | Recruiting |
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | Active Not Recruiting |
| Doc1 Healthcare Systems | Brea | California | Recruiting |
| California Dermatology & Clinical Research Institute | Encinitas | California | Active Not Recruiting |
| Marvel Clinical Research | Huntington Beach | California | Active Not Recruiting |
| University of California - Irvine | Irvine | California | Recruiting |
| Gavin Herbert Eye Institute | Irvine | California | Recruiting |
| Southern California Clinical Research | Santa Ana | California | Active Not Recruiting |
| Brett King MD, LLC | Fairfield | Connecticut | Recruiting |
| Alliance for Multispecialty Research, LLC | Fort Myers | Florida | Active Not Recruiting |
| Robert B. Pritt, DO, PA | Fort Myers | Florida | Active Not Recruiting |
| Pediatric Skin Research | Miami | Florida | Recruiting |
| Skin Research of South Florida | Miami | Florida | Recruiting |
| ForCare Clinical Research | Tampa | Florida | Active Not Recruiting |
| Olympian Clinical Research - Tampa - Memorial Highway | Tampa | Florida | Active Not Recruiting |
| Endeavor Health Audiology -CHICAGO | Chicago | Illinois | Active Not Recruiting |
| Endeavor Health Audiology -LAKE BLUFF | Lake Bluff | Illinois | Active Not Recruiting |
| Endeavor Health Audiology-NORTHBROOK | Northbrook | Illinois | Active Not Recruiting |
| Endeavor Health Audiology-SKOKIE | Skokie | Illinois | Active Not Recruiting |
| Endeavor Health Imaging & Radiology Serviccs - Old Orchard | Skokie | Illinois | Active Not Recruiting |
| Endeavor Health Lab Services - Old Orchard | Skokie | Illinois | Active Not Recruiting |
| Endeavor Health | Skokie | Illinois | Active Not Recruiting |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Callender Center for Clinical Research | Glenn Dale | Maryland | Active Not Recruiting |
| Dermatology and Skin Cancer Specialists, LLC | Rockville | Maryland | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Active Not Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Active Not Recruiting |
| The General Hospital Corporation d/b/a Massachusetts General Hospital | Boston | Massachusetts | Active Not Recruiting |
| Revival Research Institute, LLC | Troy | Michigan | Active Not Recruiting |
| University of Minnesota Clinics and Surgery Center Department of Radiology | Minneapolis | Minnesota | Recruiting |
| University of Minnesota Clinics and Surgery Center Department of Audiology | Minneapolis | Minnesota | Recruiting |
| University of Minnesota Clinics and Surgery Center Department of Radiology | Minneapolis | Minnesota | Recruiting |
| University of Minnesota Health Clinical Research Unit (M Health CRU) | Minneapolis | Minnesota | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Active Not Recruiting |
| UNC Dermatology and Skin Cancer Center | Chapel Hill | North Carolina | Active Not Recruiting |
| Clinical & Translational Research Center (CTRC) | Chapel Hill | North Carolina | Active Not Recruiting |
+ 106 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06873945 on ClinicalTrials.gov ↗ ← All trials in Japan