A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
Public ClinicalTrials.gov record NCT06873945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06873945
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,330 participants
Conditions and interventions
Conditions
Interventions
- Ritlecitinib 100 mg Drug
- Ritlecitinib 50 mg Drug
- Placebo - 100 mg Drug
- Placebo - 50 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2025
- Primary completion
- Mar 18, 2028
- Completion
- Mar 18, 2028
- Last update posted
- Aug 12, 2026
2025 – 2028
United States locations
- U.S. sites
- 60
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirklin Clinic of UAB Hospital (Radiology) | Birmingham | Alabama | 35233 | Active, not recruiting |
| University of Alabama at Birmingham Faculty Office Towers (Regulatory) | Birmingham | Alabama | 35233 | Active, not recruiting |
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Active, not recruiting |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | Active, not recruiting |
| Doc1 Healthcare Systems | Brea | California | 92821 | Recruiting |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | Active, not recruiting |
| Marvel Clinical Research | Huntington Beach | California | 92647 | Active, not recruiting |
| University of California - Irvine | Irvine | California | 92617 | Recruiting |
| Gavin Herbert Eye Institute | Irvine | California | 92697 | Recruiting |
| Southern California Clinical Research | Santa Ana | California | 92701 | Active, not recruiting |
| Brett King MD, LLC | Fairfield | Connecticut | 06824 | Active, not recruiting |
| Alliance for Multispecialty Research, LLC | Fort Myers | Florida | 33912 | Active, not recruiting |
| Robert B. Pritt, DO, PA | Fort Myers | Florida | 33912 | Active, not recruiting |
| Pediatric Skin Research | Miami | Florida | 33156 | Active, not recruiting |
| Skin Research of South Florida | Miami | Florida | 33173 | Active, not recruiting |
| ForCare Clinical Research | Tampa | Florida | 33613 | Active, not recruiting |
| Olympian Clinical Research - Tampa - Memorial Highway | Tampa | Florida | 33615 | Active, not recruiting |
| Endeavor Health Audiology -CHICAGO | Chicago | Illinois | 60625 | Active, not recruiting |
| Endeavor Health Audiology -LAKE BLUFF | Lake Bluff | Illinois | 60044 | Active, not recruiting |
| Endeavor Health Audiology-NORTHBROOK | Northbrook | Illinois | 60062 | Active, not recruiting |
| Endeavor Health Audiology-SKOKIE | Skokie | Illinois | 60076 | Active, not recruiting |
| Endeavor Health Imaging & Radiology Serviccs - Old Orchard | Skokie | Illinois | 60077 | Active, not recruiting |
| Endeavor Health Lab Services - Old Orchard | Skokie | Illinois | 60077 | Active, not recruiting |
| Endeavor Health | Skokie | Illinois | 60077 | Active, not recruiting |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | Active, not recruiting |
| University of Iowa | Iowa City | Iowa | 52242 | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21218 | Active, not recruiting |
| Callender Center for Clinical Research | Glenn Dale | Maryland | 20769 | Active, not recruiting |
| Dermatology and Skin Cancer Specialists, LLC | Rockville | Maryland | 20850 | Active, not recruiting |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Active, not recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Active, not recruiting |
| The General Hospital Corporation d/b/a Massachusetts General Hospital | Boston | Massachusetts | 02114 | Active, not recruiting |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | Active, not recruiting |
| University of Minnesota Clinics and Surgery Center Department of Radiology | Minneapolis | Minnesota | 55454 | Recruiting |
| University of Minnesota Clinics and Surgery Center Department of Audiology | Minneapolis | Minnesota | 55455 | Recruiting |
| University of Minnesota Clinics and Surgery Center Department of Radiology | Minneapolis | Minnesota | 55455 | Recruiting |
| University of Minnesota Health Clinical Research Unit (M Health CRU) | Minneapolis | Minnesota | 55455 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Active, not recruiting |
| UNC Dermatology and Skin Cancer Center | Chapel Hill | North Carolina | 27516 | Active, not recruiting |
| Clinical & Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599 | Active, not recruiting |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28211 | Active, not recruiting |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | Active, not recruiting |
| Apex Clinical Research Center - Canton | Canton | Ohio | 44718 | Active, not recruiting |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | Recruiting |
| Oregon Medical Research Center | Portland | Oregon | 97201 | Active, not recruiting |
| Northwest Dermatology Institute | Portland | Oregon | 97210 | Active, not recruiting |
| NW Dermatology Institute | Portland | Oregon | 97210 | Active, not recruiting |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | Active, not recruiting |
| Medical University of South Carolina - South Carolina Translational Research Nexus Clinic | Charleston | South Carolina | 29425 | Active, not recruiting |
| Alliance for Multispecialty Research, LLC | Myrtle Beach | South Carolina | 29588 | Active, not recruiting |
| Arlington Research Center | Arlington | Texas | 76011 | Active, not recruiting |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | Not yet recruiting |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | Active, not recruiting |
| Center for Clinical Studies | Houston | Texas | 77004 | Recruiting |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | Active, not recruiting |
| Center for Clinical Studies - Clear Lake | Webster | Texas | 77598 | Recruiting |
| AMR Clinical | Layton | Utah | 84041 | Active, not recruiting |
| University of Utah | Murray | Utah | 84107 | Active, not recruiting |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | Active, not recruiting |
| Principle Research Solutions | Spokane | Washington | 99202 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 87 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06873945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06873945 live on ClinicalTrials.gov.