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AzTrials

Alopecia AreataPhase 3ALLEGRO-100NCT06873945

A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

A Phase 3 study testing Ritlecitinib 100 mg and Ritlecitinib 50 mg in people with Alopecia Areata, run by Pfizer at 148 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. 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
674 participants
Where
148 sitesin 11 countries
Study dates
1 Apr 2025to 19 Mar 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

  • Age:
  • 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:
  • Must meet the following alopecia areata criteria at both Screening and Baseline:
  • Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
  • ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
  • Current episode of hair loss ≤10 years.

Who cannot join

  • Medical Conditions:
  • 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.
  • 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.
  • Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
  • 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.
Show all 30Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.
  • Prior/Concurrent Clinical Study Experience:
  • 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:
  • Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
  • Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.
  • Other Exclusion Criteria:
  • 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.

Trial locations and contacts

148 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

148 sites in 11 countries

United States60 sites, 31 recruiting

  • Arlington Research Center

    Arlington, Texas, 76011

    Active, not recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Recruiting

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

    Not yet recruiting

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

    Recruiting

  • The Kirklin Clinic of UAB Hospital (Radiology)

    Birmingham, Alabama, 35233

    Recruiting

  • University of Alabama at Birmingham Faculty Office Towers (Regulatory)

    Birmingham, Alabama, 35233

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Active, not recruiting

  • The General Hospital Corporation d/b/a Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Active, not recruiting

  • Doc1 Healthcare Systems

    Brea, California, 92821

    Recruiting

  • Apex Clinical Research Center - Canton

    Canton, Ohio, 44718

    Active, not recruiting

  • UNC Dermatology and Skin Cancer Center

    Chapel Hill, North Carolina, 27516

    Active, not recruiting

  • Clinical & Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599

    Active, not recruiting

  • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic

    Charleston, South Carolina, 29425

    Active, not recruiting

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28211

    Active, not recruiting

  • Endeavor Health Audiology -CHICAGO

    Chicago, Illinois, 60625

    Recruiting

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

    Active, not recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

    Active, not recruiting

  • Brett King MD, LLC

    Fairfield, Connecticut, 06824

    Recruiting

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

    Active, not recruiting

  • Robert B. Pritt, DO, PA

    Fort Myers, Florida, 33912

    Active, not recruiting

  • Callender Center for Clinical Research

    Glenn Dale, Maryland, 20769

    Active, not recruiting

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

    Active, not recruiting

  • Center for Clinical Studies

    Houston, Texas, 77004

    Recruiting

  • Marvel Clinical Research

    Huntington Beach, California, 92647

    Active, not recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • University of California - Irvine

    Irvine, California, 92617

    Recruiting

  • Gavin Herbert Eye Institute

    Irvine, California, 92697

    Recruiting

  • Endeavor Health Audiology -LAKE BLUFF

    Lake Bluff, Illinois, 60044

    Recruiting

  • AMR Clinical

    Layton, Utah, 84041

    Active, not recruiting

  • Pediatric Skin Research

    Miami, Florida, 33156

    Recruiting

  • Skin Research of South Florida

    Miami, Florida, 33173

    Recruiting

  • University of Minnesota Clinics and Surgery Center Department of Radiology

    Minneapolis, Minnesota, 55454

    Recruiting

  • University of Minnesota Clinics and Surgery Center Department of Audiology

    Minneapolis, Minnesota, 55455

    Recruiting

  • University of Minnesota Clinics and Surgery Center Department of Radiology

    Minneapolis, Minnesota, 55455

    Recruiting

  • University of Minnesota Health Clinical Research Unit (M Health CRU)

    Minneapolis, Minnesota, 55455

    Recruiting

  • University of Utah

    Murray, Utah, 84107

    Active, not recruiting

  • Alliance for Multispecialty Research, LLC

    Myrtle Beach, South Carolina, 29588

    Active, not recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Endeavor Health Audiology-NORTHBROOK

    Northbrook, Illinois, 60062

    Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462

    Active, not recruiting

  • Oregon Medical Research Center

    Portland, Oregon, 97201

    Active, not recruiting

  • Northwest Dermatology Institute

    Portland, Oregon, 97210

    Active, not recruiting

  • NW Dermatology Institute

    Portland, Oregon, 97210

    Active, not recruiting

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland, 20850

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

    Recruiting

  • Southern California Clinical Research

    Santa Ana, California, 92701

    Active, not recruiting

  • Endeavor Health Audiology-SKOKIE

    Skokie, Illinois, 60076

    Recruiting

  • Endeavor Health Imaging & Radiology Serviccs - Old Orchard

    Skokie, Illinois, 60077

    Recruiting

  • Endeavor Health Lab Services - Old Orchard

    Skokie, Illinois, 60077

    Recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

    Active, not recruiting

  • Principle Research Solutions

    Spokane, Washington, 99202

    Active, not recruiting

  • ForCare Clinical Research

    Tampa, Florida, 33613

    Active, not recruiting

  • Olympian Clinical Research - Tampa - Memorial Highway

    Tampa, Florida, 33615

    Active, not recruiting

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

    Active, not recruiting

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

    Recruiting

  • Center for Clinical Studies - Clear Lake

    Webster, Texas, 77598

    Recruiting

Other trials in United States

Canada18 sites

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

    Active, not recruiting

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

    Active, not recruiting

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B7

    Active, not recruiting

  • DermEffects

    London, Ontario, N6H 5L5

    Active, not recruiting

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

    Active, not recruiting

  • Centre de Recherche Saint-Louis

    Montreal, Quebec, H1Y 3L1

    Active, not recruiting

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

    Active, not recruiting

  • Ryan Clinical Research Inc.

    Newmarket, Ontario, L3Y 5G8

    Active, not recruiting

  • The Centre for Clinical Trials

    Oakville, Ontario, L6J 7W5

    Active, not recruiting

  • JRB Research Inc.

    Ottawa, Ontario, K1K 4L2

    Active, not recruiting

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

    Active, not recruiting

  • Centre de Recherche Saint-Louis

    Québec, G1V 3V9

    Active, not recruiting

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Québec, G1V 4X7

    Active, not recruiting

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

    Active, not recruiting

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4

    Active, not recruiting

  • Centre de Recherche Saint-Louis

    Sherbrooke, Quebec, J1G 1X9

    Active, not recruiting

  • Dermatology on Bloor - Research Toronto

    Toronto, Ontario, M4W 2N4

    Active, not recruiting

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

    Active, not recruiting

Other trials in Canada

China18 sites, 2 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Active, not recruiting

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100032

    Active, not recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Active, not recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100192

    Active, not recruiting

  • Beijing Friendship hospital, Capital Medical University

    Beijing, 100050

    Active, not recruiting

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, 100730

    Active, not recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

    Active, not recruiting

  • Chengdu second people's hospital

    Chengdu, Sichuan, 610017

    Active, not recruiting

  • The Second Affiliated Hospital Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510140

    Active, not recruiting

  • Hangzhou Third Hospital

    Hangzhou, Zhejiang, 310009

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Active, not recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Active, not recruiting

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi

    Active, not recruiting

  • Nanjing Medical University (NMU) - Jiangsu Province Hospital

    Nanjing, 210029

    Active, not recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Active, not recruiting

  • Shanghai Children's Hospital

    Shanghai, 200062

    Recruiting

Other trials in China

Poland14 sites

  • Penta Hospitals Badania Kliniczne sp. z o.o.

    Gdansk, 80-546

    Active, not recruiting

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

    Active, not recruiting

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka

    Krakow, Lesser Poland Voivodeship, 30-002

    Active, not recruiting

  • DERMEDIC Iwona Zdybska

    Lublin, Lublin Voivodeship, 20-607

    Active, not recruiting

  • Twoja Przychodnia NCM

    Nowa Sól, Lubusz Voivodeship, 67-100

    Active, not recruiting

  • DERMEDIC Iwona Zdybska

    Ostrowiec Świętokrzyski, 27-400

    Active, not recruiting

  • Twoja Przychodnia PCM

    Poznan, Greater Poland Voivodeship, 60-324

    Active, not recruiting

  • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu

    Sosnowiec, Silesian Voivodeship, 41-200

    Active, not recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-500

    Active, not recruiting

  • Klinika Osipowicz & Turkowski

    Warsaw, Masovian Voivodeship, 00-716

    Active, not recruiting

  • Dr Sękowska Leczenie Bólu

    Warsaw, Masovian Voivodeship, 01-018

    Active, not recruiting

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

    Active, not recruiting

  • NZOZ GynCentrum - Oddział Warszawa

    Warsaw, 00-124

    Active, not recruiting

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Lower Silesian Voivodeship, 50-566

    Active, not recruiting

Other trials in Poland

South Korea10 sites, 5 recruiting

  • Pusan National University Hospital

    Busan, Pusan-kwangyǒkshi, 49241

    Recruiting

  • Dankook University Hospital

    Cheonan-si, Chungcheongnam-do [chungnam], 31116

    Recruiting

  • Kyungpook National University Hospital

    Daegu, Taegu-kwangyǒkshi, 41944

    Active, not recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeonrabugdo, 54907

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Active, not recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03312

    Active, not recruiting

  • Konkuk University Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05030

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul-teukbyeolsi [seoul], 05278

    Active, not recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory

    Seoul, 07061

    Recruiting

Other trials in South Korea

Japan8 sites, 4 recruiting

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

    Recruiting

  • Juntendo Tokyo Koto Geriatric Medical Center

    Koto-ku, Tokyo, 136-0075

    Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

    Active, not recruiting

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

    Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

    Active, not recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Active, not recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Active, not recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

Other trials in Japan

Spain6 sites

  • AUDIKA

    Córdoba, Andalusia, 14001

    Active, not recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

    Active, not recruiting

  • Grupo Pedro Jaén

    Madrid, 28006

    Active, not recruiting

  • Resonancia Magnetica Nuestra Senora del Rosario

    Madrid, 28006

    Active, not recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña], 15706

    Active, not recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Active, not recruiting

Other trials in Spain

United Kingdom6 sites

  • Ninewells Hospital and Medical School

    Dundee, Dundee CITY, DD1 9SY

    Active, not recruiting

  • University Hospitals Sussex NHS Foundation Trust

    East Sussex, Brighton AND HOVE, BN2 1ES

    Active, not recruiting

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England, SW10 9NH

    Active, not recruiting

  • Guy's & St Thomas' NHS Foundation Trust

    London, London, CITY of, SE1 9RT

    Active, not recruiting

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH

    Active, not recruiting

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, WEST Sussex, BN11 2DH

    Active, not recruiting

Other trials in United Kingdom

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Active, not recruiting

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Active, not recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Active, not recruiting

Other trials in Taiwan

Czechia3 sites

  • Pratia Czech s.r.o.

    Pardubice, 53002

    Active, not recruiting

  • Fakultni Nemocnice Plzen

    Pilsen, Plzeň Region, 301 00

    Active, not recruiting

  • Kozni ambulance Fialova s.r.o

    Prague, Praha 6, 160 00

    Active, not recruiting

Other trials in Czechia

Puerto Rico1 site

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

    Active, not recruiting

Other trials in Puerto Rico

About this study

Official title: A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

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.

Read more

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.
Conditions
Alopecia Areata
Being tested
Ritlecitinib 100 mg, Ritlecitinib 50 mg, Placebo - 100 mg, Placebo - 50 mg
Keywords
alopecia universalis, alopecia totalis, alopecia, patchy hair loss, diffuse hair loss, ophiasis, hair disease, Ritlecitinib, Litfulo, hair loss, adolescents, adults
Medical subject headings
Alopecia Areata, Alopecia universalis, Alopecia, Hair Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ritlecitinib 100 mgDrug

    Also called PF-06651600, Litfulo

    100 mg Capsule

  • Ritlecitinib 50 mgDrug

    Also called PF-06651600, Litfulo

    50 mg Capsule

  • Placebo - 100 mgDrug

    Capsule (to match Ritlecitinib 100 mg)

  • Placebo - 50 mgDrug

    Capsule (to match Ritlecitinib 50 mg)

Study groups in NCT06873945
Study groupRoleWhat they receive
Ritlecitinib 50 mgExperimentalParticipants 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.
Receives: Drug: Ritlecitinib 50 mg; Drug: Placebo - 100 mg
External PlaceboNo interventionThis 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.
Ritlecitinib 100 mg (open-label)ExperimentalParticipants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.
Receives: Drug: Ritlecitinib 100 mg
Ritlecitinib 100 mgExperimentalParticipants 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.
Receives: Drug: Ritlecitinib 100 mg; Drug: Placebo - 50 mg
Synthetic PlaceboNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 24

  2. 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

    Measured: Baseline to Follow-up visit (Week 52)

  3. 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

    Measured: Baseline to Follow-up visit (Week 52)

Secondary outcomes (35)

  1. 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

    Measured: Week 24

  2. 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

    Measured: Week 24

  3. 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

    Measured: Week 36

  4. 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

    Measured: Week 24

  5. 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

    Measured: Week 24

  6. 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

    Measured: Baseline through Week 24

  7. 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

    Measured: Baseline through Week 24

  8. 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

    Measured: Baseline through Week 24

  9. 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

    Measured: Baseline through Week 24

  10. 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

    Measured: Baseline through Week 24

  11. 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

    Measured: Baseline through Week 24

  12. 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

    Measured: Baseline through Week 24

  13. 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

    Measured: Week 24

  14. 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

    Measured: Week 24

  15. 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

    Measured: Week 24

  16. 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

    Measured: Week 48

  17. 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

    Measured: Week 48

  18. 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

    Measured: Week 48

  19. 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

    Measured: Week 48

  20. 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

    Measured: Week 24 through Week 48

  21. 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

    Measured: Week 24 through Week 48

  22. 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

    Measured: Week 24 through Week 48

  23. 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

    Measured: Week 24 through Week 48

  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)

    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

    Measured: Week 24 through Week 48

  25. 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

    Measured: Week 24 through Week 48

  26. 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

    Measured: Week 24 through Week 48

  27. 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

    Measured: Baseline through Week 48

  28. 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

    Measured: Baseline through Week 48

  29. 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

    Measured: Baseline through Week 48

  30. Part 2: Change from baseline in SALT score

    Mean change from baseline in SALT score for ritlecitinib 100 mg QD

    Measured: Baseline through Week 48

  31. 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

    Measured: Baseline through Week 48

  32. 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

    Measured: Baseline through Week 48

  33. 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

    Measured: Baseline through Week 48

  34. 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

    Measured: Baseline to Follow-up visit (Week 52)

  35. 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

    Measured: Baseline to Follow-up visit (Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion19 Mar 2028 (estimated)
  4. Study completion19 Mar 2028 (estimated)

Resources

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
674 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873945
Sponsor's protocol ID
B7981094
Other IDs
2024-519370-40-00
Acronym
ALLEGRO-100
Status last verified
Oct 2026
First submitted
7 Mar 2025
Last updated
20 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

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.

    PubMed 41083802

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 148 sites in 11 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 7 inclusion and 30 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 20 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 148 sites in United States, Canada, China, Poland, South Korea and 6 more countries. 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. 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?

Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20 (time frame: Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06873945, which also lists 1 linked publication.

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 20 Oct 2026.

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ALLEGRO-100 Clinical Trial NCT06873945 | AzTrials