Alopecia AreataPhase 3NCT07733765
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
A Phase 3 study testing Ritlecitinib 100 mg and Ritlecitinib 50 mg in people with Alopecia Areata, run by Pfizer at 38 sites in 5 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Ritlecitinib 100 mg and Ritlecitinib 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 30 Jul 2026to 26 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 1. Diseases or conditions affecting hair loss, including:
- Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
- 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).
Trial locations and contacts
38 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 5 countries
United States21 sites, 21 recruiting
- Not yet recruiting
Cutaneous Translational Research Program, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
- Not yet recruiting
Johns Hopkins Hospital Investigational Drug Services (IDS) Pharmacy
Baltimore, Maryland, 21287
- Recruiting
Bexley Dermatology Research
Bexley, Ohio, 43209
- Recruiting
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114
- Recruiting
Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27514
- Recruiting
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
- Recruiting
Audiology & Hearing Services
Charlotte, North Carolina, 28277
- Recruiting
Carolinas Imaging Service
Charlotte, North Carolina, 28277
- Recruiting
Darst Dermatology
Charlotte, North Carolina, 28277
- Recruiting
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
- Recruiting
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
- Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
Skin Research of South Florida
Miami, Florida, 33173
- Recruiting
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
- Recruiting
NW Dermatology Institute
Portland, Oregon, 97210
- Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
- Not yet recruiting
Endeavor Health
Skokie, Illinois, 60077
- Not yet recruiting
Dermatology Specialists of Spokane
Spokane, Washington, 99202
- Not yet recruiting
Principle Research Solutions
Spokane, Washington, 99202
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Japan7 sites, 7 recruiting
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, 807-8556
- Recruiting
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, 136-0075
- Recruiting
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Canada5 sites, 5 recruiting
- Recruiting
Centre de Recherche Saint-Louis (Montréal)
Montreal, Quebec, H1Y 3L1
- Recruiting
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
- Recruiting
Centre de Recherche Saint-Louis (Québec)
Québec, Quebec, G1W 4R4
- Recruiting
Research Toronto
Toronto, Ontario, M4W 2N4
- Recruiting
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
South Korea3 sites, 3 recruiting
- Not yet recruiting
Jeonbuk National University Hospital
Jeonju, Jeonrabugdo,, 54907
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [seoul], 05278
- Recruiting
Seoul National University Hospital
Seoul, 03080
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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
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).
This study is seeking participants who are
Read more
- 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.
- Conditions
- Alopecia Areata
- Being tested
- Ritlecitinib 100 mg, Ritlecitinib 50 mg, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritlecitinib 100 mgDrug
100 mg capsule taken orally once daily
Ritlecitinib 50 mgDrug
50 mg capsule taken orally once daily
PlaceboOther
Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Ritlecitinib 50 milligrams (mg) | Experimental | 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. Receives: Drug: Ritlecitinib 100 mg; Drug: Ritlecitinib 50 mg |
| Placebo | Placebo comparator | 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. Receives: Drug: Ritlecitinib 100 mg; Drug: Ritlecitinib 50 mg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Week 24
Secondary outcomes (47)
Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus
Measured: Week 24
Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus
Measured: Week 24
Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus
Measured: Week 24
Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus
Measured: Week 24
Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18 and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Week 24
Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18
Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Measured: Weeks 8, 12, 18, 24
Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period
Measured: Screening to Follow up period (up to week 57)
Proportion of responders for SALT 0 at appliable timepoints after Week 24
For each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for SALT ≤10 at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for SALT ≤5 at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for SALT 75 at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for SALT 90 at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Mean CFB in SALT score at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Proportion of responders for EBA at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for ELA at appliable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Proportion of PGI-C responders at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of P-Sat responders at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24
for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)
Measured: Weeks 28, 36, and 48
Difference in the proportion of PGI-C responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of P-SAT responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Measured: Weeks 28, 36, and 48
Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected during the safety follow-up period
Measured: Screening to Follow up period (up to 57 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Jul 2026
- Primary completion26 Apr 2028 (estimated)
- Study completion26 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733765
- Sponsor's protocol ID
- B7981110
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07733765
- Acronym / sponsor ID
- B7981110
- Conditions
- Alopecia Areata
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 26 Apr 2028 (estimated)
- Study completion
- 26 Apr 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ritlecitinib 50 milligrams (mg) | Experimental | Drug: Ritlecitinib 100 mg, Drug: Ritlecitinib 50 mgParticipants 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. |
| Placebo | Placebo comparator | Drug: Ritlecitinib 100 mg, Drug: Ritlecitinib 50 mg, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritlecitinib 100 mg100 mg capsule taken orally once daily | Drug | Placebo, Ritlecitinib 50 milligrams (mg) |
| Ritlecitinib 50 mg50 mg capsule taken orally once daily | Drug | Placebo, Ritlecitinib 50 milligrams (mg) |
| PlaceboCapsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily | Other | Placebo |
Primary outcome
Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Week 24
47 secondary outcomes
Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus
Time frame: Week 24
Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18 and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Week 24
Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18
Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 8, 12, 18, 24
Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period
Time frame: Screening to Follow up period (up to week 57)
Proportion of responders for SALT 0 at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT ≤10 at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT ≤5 at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT 75 at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for SALT 90 at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Mean CFB in SALT score at applicable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Proportion of responders for EBA at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for ELA at appliable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group
Time frame: Weeks 28, 36, and 48
Proportion of PGI-C responders at applicable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of P-Sat responders at applicable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24
Time frame: Weeks 28, 36, and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ritlecitinib 100 mg and Ritlecitinib 50 mg in people with Alopecia Areata, run by Pfizer at 38 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Canada, South Korea, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.