Ritlecitinib for patchy hair loss from moderate alopecia areata
Tests ritlecitinib against placebo in people with moderate patchy hair loss.
Key facts
- Who runs it
- Pfizer
- Where
- Baltimore, Bexley, Boston, Chapel Hill, Charlotte, Encinitas, Houston, Indianapolis, Iowa City, Miami, Plymouth Meeting, Portland, San Antonio, Skokie, Spokane, and Troy, United StatesSee the 21 sitesAlso in 4 other countries, 17 sites
- Trial code
- Registry title
- A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 336 people, planned
- Started
- 30 Jul 2026
- Expected to end
- 26 Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ritlecitinib 100 mg
- Ritlecitinib 50 mg
- Placebo
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 years or older with moderate alopecia areata, a condition causing patchy hair loss. It tests ritlecitinib against placebo.
- Age
- 12 years and older. People aged 12 to <18 years can join only where local approvals allow it. Otherwise only people 18 years and older can join.
- Sex
- All sexes can join.
- Disease stage
- Moderate alopecia areata with >20% to <50% scalp hair loss, measured by SALT. The current episode has lasted ≥6 months and ≤10 years.
Main reasons for not taking part
- Hair loss from any other cause
- Other types of alopecia, such as traction or scarring alopecia, telogen effluvium, or androgenetic alopecia
- Other scalp disease that may affect the hair loss checks, such as scalp psoriasis or dermatitis
- Active body-wide diseases that may cause hair loss, such as lupus erythematosus, thyroiditis, systemic sclerosis or lichen planus
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled
- Have a clinical diagnosis of AA with no other etiology of hair loss
- Have >20% to <50% hair loss of the scalp, as measured by SALT
- Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches)
Who cannot take part
- Diseases or conditions affecting hair loss, including:
- Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.)
- Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc)
- Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded
Where in United States
Also in 4 other countries, 17 sites
- Cutaneous Translational Research Program, Johns Hopkins University School of MedicineBaltimore, United StatesNot yet recruiting
- Johns Hopkins Hospital Investigational Drug Services (IDS) PharmacyBaltimore, United StatesNot yet recruiting
- Bexley Dermatology ResearchBexley, United StatesTaking people
- Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)Boston, United StatesTaking people
- Clinical and Translational Research Center (CTRC)Chapel Hill, United StatesTaking people
- UNC Dermatology and Skin Cancer CenterChapel Hill, United StatesTaking people
- Audiology & Hearing ServicesCharlotte, United StatesTaking people
- Carolinas Imaging ServiceCharlotte, United StatesTaking people
- Darst DermatologyCharlotte, United StatesTaking people
- California Dermatology & Clinical Research InstituteEncinitas, United StatesTaking people
- Center for Clinical Studies, LTD. LLPHouston, United StatesTaking people
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesTaking people
- University of IowaIowa City, United StatesNot yet recruiting
- Skin Research of South FloridaMiami, United StatesTaking people
- Dermatology Associates of Plymouth MeetingPlymouth Meeting, United StatesTaking people
- NW Dermatology InstitutePortland, United StatesTaking people
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesTaking people
- Endeavor HealthSkokie, United StatesNot yet recruiting
- Dermatology Specialists of SpokaneSpokane, United StatesNot yet recruiting
- Principle Research SolutionsSpokane, United StatesNot yet recruiting
- Revival Research Institute, LLCTroy, United StatesTaking people
About the trial
What the trial wants to find out
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA).
Read full original descriptionShow less
This study is seeking participants who are
* 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss.
Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks.
About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone.
We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.
The 2 groups in the trial
- Ritlecitinib 50 milligrams (mg)Treatment being tested
Participants will receive 1 ritlecitinib 50 mg capsule QD orally from Day 1 to Week 24. At Week 24: Responders will be allocated to the below: Arm 1A (Ritlecitinib 50 mg R Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be re-randomized to either of the below: Arm 1B (Ritlecitinib 50 mg NR→50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Arm 1C (Ritlecitinib 50 mg NR→100 mg Group): 1 ritlecitinib 100 mg capsule QD and 1 placebo 50 mg capsule QD orally through Week 48.
Treatment: Ritlecitinib 100 mg and Ritlecitinib 50 mg
- PlaceboPlacebo, for comparison
Participants will receive 1 placebo 50 mg capsule QD orally from Day 1 to Week 24 At Week 24: Responders will be allocated to the below: Arm 2A (Placebo R Group): 1 placebo 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48. Non-Responders will be allocated to the below: Arm 2B (Placebo NR→Ritlecitinib 50 mg Group): 1 ritlecitinib 50 mg capsule QD and 1 placebo 100 mg capsule QD orally through Week 48.
Treatment: Ritlecitinib 100 mg, Ritlecitinib 50 mg, and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA
- Plain-language title
- Ritlecitinib for patchy hair loss from moderate alopecia areataGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 26 October 2026