A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
NCT ID: NCT06873945
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
550 participants
INTERVENTIONAL
2025-04-01
2027-03-09
Brief Summary
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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
* 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 in this study.
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.
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. Participants will also be asked to complete questionnaires about their alopecia areata.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ritlecitinib 100 mg
Randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Ritlecitinib 100 mg
100 mg Capsule
Placebo - 50 mg
Capsule (to match Ritlecitinib 50 mg)
Ritlecitinib 50 mg
Randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks.
In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
Ritlecitinib 50 mg
50 mg Capsule
Placebo - 100 mg
Capsule (to match Ritlecitinib 100 mg)
External Placebo
This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24.
As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
No interventions assigned to this group
Synthetic Placebo
This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36.
As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
No interventions assigned to this group
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older 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.
Disease Characteristics:
2. Must meet the following alopecia areata criteria at both Screening and Baseline:
1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
3. Current episode of hair loss ≤10 years.
Exclusion Criteria
1. Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.
2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
4. General Infection History:
* Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
* Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
* Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
5. Specific Viral Infection History:
* History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
* Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
6. Other Medical Conditions:
* Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
* Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.
* Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
* Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.
7. Adolescent participants 12 to \<18 years of age without one of the following:
* Documented evidence from a health professional of having received varicella vaccination (2 doses); or
* Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.
8. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.
Prior/Concurrent Clinical Study Experience:
10. Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Diagnostic Assessments:
11. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.
13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Doc1 Healthcare Systems
Brea, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Brett King MD, LLC
Fairfield, Connecticut, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
Robert B. Pritt, DO, PA
Fort Myers, Florida, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
Pediatric Skin Research
Miami, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Olympian Clinical Research - Tampa - Memorial Highway
Tampa, Florida, United States
Endeavor Health
Skokie, Illinois, United States
Indiana University Health University Hospital Adult Outpatient Center
Indianapolis, Indiana, United States
Indiana University School of Medicine - Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
Sidney & Lois Eskenazi Health Center
Indianapolis, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Callender Center for Clinical Research
Glenn Dale, Maryland, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Apex Clinical Research Center - Canton
Canton, Ohio, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Northwest Dermatology Institute
Portland, Oregon, United States
NW Dermatology Institute
Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Alliance for Multispecialty Research, LLC
Myrtle Beach, South Carolina, United States
Arlington Research Center
Arlington, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies - Clear Lake
Webster, Texas, United States
AMR Clinical
Layton, Utah, United States
University of Utah
Murray, Utah, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Principle Research Solutions
Spokane, Washington, United States
CaRe Clinic
Red Deer, Alberta, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
DermEffects
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Ryan Clinical Research Inc.
Newmarket, Ontario, Canada
The Centre for Clinical Trials
Oakville, Ontario, Canada
JRB Research Inc.
Ottawa, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
Montreal, Quebec, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, , Canada
Centre de Recherche Saint-Louis inc.
Québec, , Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
2nd Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangxi Provincial Children's Hospital
Nanchang, Other, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Second Municipal People's Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Friendship hospital, Capital Medical University
Beijing, , China
Nanjing Medical University (NMU) - Jiangsu Province Hospital
Nanjing, , China
Shanghai Children's Hospital
Shanghai, , China
Kozni ambulance Fialova s.r.o
Prague, Praha 6, Czechia
Kurume University Hospital
Kurume, Fukuoka, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
Krakow, Lesser Poland Voivodeship, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland
DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, Poland
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship, Poland
Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, Poland
Dankook University Hospital
Cheonan-si, Chungcheongnam-do [chungnam], South Korea
Jeonbuk National University Hospital
Jeonju, Jeonrabugdo, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Boramae Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Hospital
Junggu, Taegu-kwangyǒkshi, South Korea
AUDIKA
Córdoba, Andalusia, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Central Contacts
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References
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King B, McMichael A, Sinclair R, Vano-Galvan S, Wolk R, Woodworth D, Soma K, Robbana F, Lejeune A, Napatalung L, Law E, Wajsbrot D, Wang C, Roychoudhury S. Rationale and Design of a Novel, Phase 3, External and Synthetic Placebo-Controlled Clinical Trial of Ritlecitinib 50 mg and 100 mg for Alopecia Areata. Dermatol Ther (Heidelb). 2025 Oct 14. doi: 10.1007/s13555-025-01543-7. Online ahead of print.
Related Links
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To obtain contact information for a study center near you, click here.
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Other Identifiers
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2024-519370-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7981094
Identifier Type: -
Identifier Source: org_study_id
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