A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata (ALLEGRO-100)

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

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 Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg; Drug: Ritlecitinib 50 mg; Drug: Placebo - 100 mg

• Study Type: Interventional
• Enrollment (Estimated): 1330
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Québec, Canada, G1V 3V9
    • Active, not recruiting
    • Centre de Recherche Saint-Louis
  • Québec, Canada, G1V 4X7
    • Active, not recruiting
    • Centre De Recherche Dermatologique Du Quebec Metropolitain
  • Québec, Canada, G1W 4R4
    • Active, not recruiting
    • Centre de Recherche Saint-Louis inc.
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Active, not recruiting
      • Dermatology Research Institute
    • Red Deer, Alberta, Canada, T4P 1K4
      • Active, not recruiting
      • Care Clinic
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Active, not recruiting
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Active, not recruiting
      • SimcoDerm Medical and Surgical Dermatology Center
    • Guelph, Ontario, Canada, N1L 0B7
      • Active, not recruiting
      • Guelph Dermatology Research
    • London, Ontario, Canada, N6H 5L5
      • Active, not recruiting
      • Dermeffects
    • Markham, Ontario, Canada, L3P 1X3
      • Active, not recruiting
      • Lynderm Research Inc.
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Active, not recruiting
      • Ryan Clinical Research Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • Active, not recruiting
      • The Centre for Clinical Trials
    • Ottawa, Ontario, Canada, K1K 4L2
      • Active, not recruiting
      • JRB Research Inc.
    • Peterborough, Ontario, Canada, K9J 5K2
      • Active, not recruiting
      • Skin Centre for Dermatology
    • Toronto, Ontario, Canada, M4W 2N4
      • Active, not recruiting
      • Dermatology on Bloor - Research Toronto
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Active, not recruiting
      • Innovaderm Research Inc.
    • Montreal, Quebec, Canada, H1Y 3L1
      • Active, not recruiting
      • Centre de Recherche Saint-Louis
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Active, not recruiting
      • Centre de Recherche Saint-Louis
• China
  • Beijing, China, 100050
    • Active, not recruiting
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China, 100730
    • Active, not recruiting
    • Beijing Tongren Hospital affiliated to Capital Medical University
  • Nanjing, China, 210029
    • Active, not recruiting
    • Nanjing Medical University (NMU) - Jiangsu Province Hospital
  • Shanghai, China, 200062
    • Recruiting
    • Shanghai Children's Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Active, not recruiting
      • China-Japan Friendship Hospital
    • Beijing, Beijing Municipality, China, 100032
      • Active, not recruiting
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100044
      • Active, not recruiting
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100192
      • Active, not recruiting
      • China-Japan Friendship Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • Active, not recruiting
      • The Second Affiliated Hospital Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510140
      • Active, not recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Active, not recruiting
      • Xiangya Hospital Central South University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Active, not recruiting
      • Jiangxi Provincial Children's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Active, not recruiting
      • Huashan Hospital, Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Active, not recruiting
      • Chengdu Second People's Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Active, not recruiting
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Active, not recruiting
      • Hangzhou Third Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Active, not recruiting
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
• Czechia
  • Pardubice, Czechia, 53002
    • Active, not recruiting
    • Pratia Czech s.r.o.
  • Plzeň Region
    • Pilsen, Plzeň Region, Czechia, 301 00
      • Active, not recruiting
      • Fakultni nemocnice Plzen
  • Praha 6
    • Prague, Praha 6, Czechia, 160 00
      • Active, not recruiting
      • Kozni ambulance Fialova s.r.o
• Japan
  • Osaka, Japan, 545-8586
    • Active, not recruiting
    • Osaka Metropolitan University Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Active, not recruiting
      • Kurume University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Active, not recruiting
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Active, not recruiting
      • Niigata University Medical & Dental Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Active, not recruiting
      • Hamamatsu University Hospital
  • Tokyo
    • Koto-ku, Tokyo, Japan, 136-0075
      • Active, not recruiting
      • Juntendo Tokyo Koto Geriatric Medical Center
    • Mitaka, Tokyo, Japan, 181-8611
      • Active, not recruiting
      • Kyorin University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Active, not recruiting
      • Tokyo Medical University Hospital
• Poland
  • Gdansk, Poland, 80-546
    • Active, not recruiting
    • Centrum Badań Klinicznych PI-House sp. z o.o.
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Active, not recruiting
    • DERMEDIC Iwona Zdybska
  • Warsaw, Poland, 00-124
    • Active, not recruiting
    • NZOZ GynCentrum - Oddział Warszawa
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-324
      • Active, not recruiting
      • Twoja Przychodnia PCM
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-002
      • Active, not recruiting
      • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
      • Active, not recruiting
      • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-607
      • Active, not recruiting
      • DERMEDIC Iwona Zdybska
  • Lubusz Voivodeship
    • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
      • Active, not recruiting
      • Twoja Przychodnia NCM
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-716
      • Active, not recruiting
      • Klinika Osipowicz & Turkowski
    • Warsaw, Masovian Voivodeship, Poland, 01-018
      • Active, not recruiting
      • Dr Sękowska Leczenie Bólu
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Active, not recruiting
      • Royalderm Agnieszka Nawrocka
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Active, not recruiting
      • Centrum Medyczne Angelius Provita
    • Sosnowiec, Silesian Voivodeship, Poland, 41-200
      • Active, not recruiting
      • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
      • Active, not recruiting
      • Twoja Przychodnia - Szczecinskie Centrum Medyczne
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Active, not recruiting
    • GCM Medical Group, PSC - Hato Rey Site
• South Korea
  • Seoul, South Korea, 07061
    • Recruiting
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
  • Chungcheongnam-do [chungnam]
    • Cheonan-si, Chungcheongnam-do [chungnam], South Korea, 31116
      • Active, not recruiting
      • Dankook University Hospital
  • Jeonrabugdo
    • Jeonju, Jeonrabugdo, South Korea, 54907
      • Active, not recruiting
      • Jeonbuk National University Hospital
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Active, not recruiting
      • Seoul National University Bundang Hospital
  • Pusan-kwangyǒkshi
    • Busan, Pusan-kwangyǒkshi, South Korea, 49241
      • Recruiting
      • Pusan National University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Active, not recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03312
      • Active, not recruiting
      • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05030
      • Active, not recruiting
      • Konkuk University Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05278
      • Active, not recruiting
      • Kyung Hee University Hospital at Gangdong
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, South Korea, 41944
      • Active, not recruiting
      • Kyungpook National University Hospital
• Spain
  • Madrid, Spain, 28006
    • Active, not recruiting
    • Grupo Pedro Jaén
  • Madrid, Spain, 28006
    • Active, not recruiting
    • Resonancia Magnetica Nuestra Senora del Rosario
  • Zaragoza, Spain, 50009
    • Active, not recruiting
    • Hospital Universitario Miguel Servet
  • A Coruña [LA Coruña]
    • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
      • Active, not recruiting
      • CHUS - Hospital Clinico Universitario
  • Andalusia
    • Córdoba, Andalusia, Spain, 14001
      • Active, not recruiting
      • AUDIKA
    • Córdoba, Andalusia, Spain, 14004
      • Active, not recruiting
      • Hospital Universitario Reina Sofia
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Active, not recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 11217
    • Active, not recruiting
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Active, not recruiting
    • Chang Gung Medical Foundation-Linkou Branch
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Active, not recruiting
      • Chang Gung Memorial Hospital at Kaohsiung
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Active, not recruiting
    • Guy's & St Thomas' NHS Foundation Trust
  • Brighton AND HOVE
    • East Sussex, Brighton AND HOVE, United Kingdom, BN2 1ES
      • Active, not recruiting
      • University Hospitals Sussex NHS Foundation Trust
  • Dundee CITY
    • Dundee, Dundee CITY, United Kingdom, DD1 9SY
      • Active, not recruiting
      • Ninewells Hospital and Medical School
  • England
    • London, England, United Kingdom, SW10 9NH
      • Active, not recruiting
      • Chelsea and Westminster hospital NHS foundation Trust
  • London, CITY of
    • London, London, CITY of, United Kingdom, SE1 9RT
      • Active, not recruiting
      • Guy's & St Thomas' NHS Foundation Trust
  • WEST Sussex
    • Worthing, WEST Sussex, United Kingdom, BN11 2DH
      • Active, not recruiting
      • University Hospitals Sussex NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Active, not recruiting
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35233
      • Active, not recruiting
      • The Kirklin Clinic of UAB Hospital (Radiology)
    • Birmingham, Alabama, United States, 35233
      • Active, not recruiting
      • University of Alabama at Birmingham Faculty Office Towers (Regulatory)
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Active, not recruiting
      • Burke Pharmaceutical Research
  • California
    • Brea, California, United States, 92821
      • Recruiting
      • Doc1 Healthcare Systems
    • Encinitas, California, United States, 92024
      • Active, not recruiting
      • California Dermatology & Clinical Research Institute
    • Huntington Beach, California, United States, 92647
      • Active, not recruiting
      • Marvel Clinical Research
    • Irvine, California, United States, 92617
      • Recruiting
      • University of California - Irvine
    • Irvine, California, United States, 92697
      • Recruiting
      • Gavin Herbert Eye Institute
    • Santa Ana, California, United States, 92701
      • Active, not recruiting
      • Southern California Clinical Research
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Active, not recruiting
      • Brett King MD, LLC
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Active, not recruiting
      • Alliance for Multispecialty Research, LLC
    • Fort Myers, Florida, United States, 33912
      • Active, not recruiting
      • Robert B. Pritt, DO, PA
    • Miami, Florida, United States, 33173
      • Active, not recruiting
      • Skin Research of South Florida
    • Miami, Florida, United States, 33156
      • Active, not recruiting
      • Pediatric Skin Research
    • Tampa, Florida, United States, 33613
      • Active, not recruiting
      • ForCare Clinical Research
    • Tampa, Florida, United States, 33615
      • Active, not recruiting
      • Olympian Clinical Research - Tampa - Memorial Highway
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Active, not recruiting
      • Endeavor Health Audiology -CHICAGO
    • Lake Bluff, Illinois, United States, 60044
      • Active, not recruiting
      • Endeavor Health Audiology -LAKE BLUFF
    • Northbrook, Illinois, United States, 60062
      • Active, not recruiting
      • Endeavor Health Audiology-NORTHBROOK
    • Skokie, Illinois, United States, 60077
      • Active, not recruiting
      • Endeavor Health
    • Skokie, Illinois, United States, 60076
      • Active, not recruiting
      • Endeavor Health Audiology-SKOKIE
    • Skokie, Illinois, United States, 60077
      • Active, not recruiting
      • Endeavor Health Imaging & Radiology Serviccs - Old Orchard
    • Skokie, Illinois, United States, 60077
      • Active, not recruiting
      • Endeavor Health Lab Services - Old Orchard
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Active, not recruiting
      • Dawes Fretzin Clinical Research Group, LLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Active, not recruiting
      • Johns Hopkins University
    • Glenn Dale, Maryland, United States, 20769
      • Active, not recruiting
      • Callender Center for Clinical Research
    • Rockville, Maryland, United States, 20850
      • Active, not recruiting
      • Dermatology and Skin Cancer Specialists, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Active, not recruiting
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Active, not recruiting
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • Active, not recruiting
      • The General Hospital Corporation d/b/a Massachusetts General Hospital
  • Michigan
    • Troy, Michigan, United States, 48084
      • Active, not recruiting
      • Revival Research Institute, LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Health Clinical Research Unit (M Health CRU)
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota Clinics and Surgery Center Department of Radiology
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Clinics and Surgery Center Department of Audiology
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Clinics and Surgery Center Department of Radiology
  • New York
    • New York, New York, United States, 10029
      • Active, not recruiting
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Active, not recruiting
      • UNC Dermatology and Skin Cancer Center
    • Chapel Hill, North Carolina, United States, 27599
      • Active, not recruiting
      • Clinical & Translational Research Center (CTRC)
    • Charlotte, North Carolina, United States, 28211
      • Active, not recruiting
      • DJL Clinical Research, PLLC
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Active, not recruiting
      • Bexley dermatology research
    • Canton, Ohio, United States, 44718
      • Active, not recruiting
      • Apex Clinical Research Center - Canton
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Vital Prospects Clinical Research Institute, PC
  • Oregon
    • Portland, Oregon, United States, 97201
      • Active, not recruiting
      • Oregon Medical Research Center
    • Portland, Oregon, United States, 97210
      • Active, not recruiting
      • Northwest Dermatology Institute
    • Portland, Oregon, United States, 97210
      • Active, not recruiting
      • NW Dermatology Institute
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Active, not recruiting
      • Dermatology Associates of Plymouth Meeting
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Active, not recruiting
      • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
    • Myrtle Beach, South Carolina, United States, 29588
      • Active, not recruiting
      • Alliance for Multispecialty Research, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Active, not recruiting
      • Arlington Research Center
    • Bellaire, Texas, United States, 77401
      • Not yet recruiting
      • The University of Texas Health Science Center at Houston
    • Dallas, Texas, United States, 75230
      • Active, not recruiting
      • Dermatology Treatment and Research Center
    • Houston, Texas, United States, 77004
      • Recruiting
      • Center for Clinical Studies
    • San Antonio, Texas, United States, 78218
      • Active, not recruiting
      • Texas Dermatology and Laser Specialists
    • Webster, Texas, United States, 77598
      • Recruiting
      • Center for Clinical Studies - Clear Lake
  • Utah
    • Layton, Utah, United States, 84041
      • Active, not recruiting
      • AMR Clinical
    • Murray, Utah, United States, 84107
      • Active, not recruiting
      • University of Utah
  • Washington
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Dermatology Specialists of Spokane
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Principle Research Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age:

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. In Part 2 of the study, only adolescents (12 to <18 years of age at both Screening and Day 1) who did not participate in Part 1 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:

Medical Conditions:

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. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib.

    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.

    Other Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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 Intervention: 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.
Experimental: Ritlecitinib 50 mg; Participants in Part 1 will be 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. Data from participants who are non-responders (ie, had a SALT score greater than 20) at Week 24 and re-randomized to Ritlecitinib 50 mg will be augmented with data from an External Ritlecitinib 50 mg QD Group for comparisons at Week 48. The External Ritlecitinib 50 mg QD Group will be constructed using patient-level data from the appropriately chosen Pfizer clinical study in participants who received Ritlecitinib 50 mg QD and were non-responders at Week 24 and continued receiving ritlecitinib 50 mg QD up to Week 48. 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.	Drug: Ritlecitinib 50 mg; 50 mg Capsule; Other Names: PF-06651600; Litfulo; Drug: Placebo - 100 mg; Capsule (to match Ritlecitinib 100 mg)
Experimental: Ritlecitinib 100 mg; Participants in Part 1 will be 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.	Drug: Ritlecitinib 100 mg; 100 mg Capsule; Other Names: PF-06651600; Litfulo; Drug: Placebo - 50 mg; Capsule (to match Ritlecitinib 50 mg)
Experimental: Ritlecitinib 100 mg (open-label); Participants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.	Drug: Ritlecitinib 100 mg; 100 mg Capsule; Other Names: PF-06651600; Litfulo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo	Week 24
Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation	Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD	Baseline to Follow-up visit (Week 52)
Part 2: Percentage of participants with clinically significant laboratory abnormalities	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	Baseline to Follow-up visit (Week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Percentage of participants with absolute SALT score less than or equal to 20	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"	Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo	Week 36
Part 1: Change from baseline in SALT score	Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0	Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10	Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0	Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Change from baseline in SALT score	Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"	Difference in the percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD	Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10	Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo	Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20	Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg non-responder (NR)-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD	Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10	Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD	Week 48
Part 1: Change from Week 24 in SALT score	Difference in the mean absolute change from Week 24 in SALT score between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD	Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"	Percentage of participants with PGI-C response between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD	Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 20	Percentage of participants with SALT score less than or equal to 20 for ritlecitinib 100 mg QD, ritlecitinib 50 mg responder (R)-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10	Percentage of participants with SALT score less than or equal to 10 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score equal to 0	Percentage of participants with SALT score equal to 0 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Change from Week 24 in SALT score	Mean absolute change from Week 24 in SALT score for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Percentage of participants with EBA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Percentage of participants with ELA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"	Percentage of participants with PGI-C response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD	Week 24 through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 20	Percentage of participants with absolute SALT score less than or equal to 20 for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 10	Percentage of participants with absolute SALT score less than or equal to 10 for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score equal to 0	Percentage of participants with absolute SALT score equal to 0 for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Change from baseline in SALT score	Mean change from baseline in SALT score for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)	Percentage of participants with EBA response for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)	Percentage of participants with ELA response for ritlecitinib 100 mg QD	Baseline through Week 48
Part 2: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"	Percentage of participants with PGI-C response for ritlecitinib 100 mg QD	Baseline through Week 48
Part 1: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation	Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg	Baseline to Follow-up visit (Week 52)
Part 1: Percentage of participants with clinically significant laboratory abnormalities	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 and ritlecitinib 50 mg	Baseline to Follow-up visit (Week 52)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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 Dec;15(12):3793-3803. doi: 10.1007/s13555-025-01543-7. Epub 2025 Oct 14.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): March 19, 2028

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: adolescents; adults; alopecia; hair loss; Ritlecitinib; alopecia totalis; alopecia universalis; ophiasis; patchy hair loss; diffuse hair loss; hair disease; Litfulo
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia Areata; Alopecia; Hair Diseases; Alopecia universalis; Substandard Drugs; Pharmaceutical Preparations; PF-06651600
• Other Study ID Numbers: B7981094; 2024-519370-40-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No