Alopecia Areata Clinical Trials

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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

Status: Recruiting
Location: See all (144) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital (Radiology)
ACTIVE_NOT_RECRUITING
Birmingham
University of Alabama at Birmingham
ACTIVE_NOT_RECRUITING
Birmingham
University of Alabama at Birmingham Faculty Office Towers (Regulatory)
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
Burke Pharmaceutical Research
ACTIVE_NOT_RECRUITING
Hot Springs
California
Doc1 Healthcare Systems
RECRUITING
Brea
California Dermatology & Clinical Research Institute
ACTIVE_NOT_RECRUITING
Encinitas
Marvel Clinical Research
ACTIVE_NOT_RECRUITING
Huntington Beach
Gavin Herbert Eye Institute
RECRUITING
Irvine
University of California - Irvine
RECRUITING
Irvine
Southern California Clinical Research
ACTIVE_NOT_RECRUITING
Santa Ana
Connecticut
Brett King MD, LLC
ACTIVE_NOT_RECRUITING
Fairfield
Florida
Alliance for Multispecialty Research, LLC
ACTIVE_NOT_RECRUITING
Fort Myers
Robert B. Pritt, DO, PA
ACTIVE_NOT_RECRUITING
Fort Myers
Pediatric Skin Research
ACTIVE_NOT_RECRUITING
Miami
Skin Research of South Florida
ACTIVE_NOT_RECRUITING
Miami
ForCare Clinical Research
ACTIVE_NOT_RECRUITING
Tampa
Olympian Clinical Research - Tampa - Memorial Highway
ACTIVE_NOT_RECRUITING
Tampa
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Endeavor Health Audiology -CHICAGO
ACTIVE_NOT_RECRUITING
Chicago
Endeavor Health Audiology -LAKE BLUFF
ACTIVE_NOT_RECRUITING
Lake Bluff
Endeavor Health Audiology-NORTHBROOK
ACTIVE_NOT_RECRUITING
Northbrook
Endeavor Health
ACTIVE_NOT_RECRUITING
Skokie
Endeavor Health Audiology-SKOKIE
ACTIVE_NOT_RECRUITING
Skokie
Endeavor Health Imaging & Radiology Serviccs - Old Orchard
ACTIVE_NOT_RECRUITING
Skokie
Endeavor Health Lab Services - Old Orchard
ACTIVE_NOT_RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
ACTIVE_NOT_RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
The General Hospital Corporation d/b/a Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
Tufts Medical Center
ACTIVE_NOT_RECRUITING
Boston
Maryland
Johns Hopkins University
ACTIVE_NOT_RECRUITING
Baltimore
Callender Center for Clinical Research
ACTIVE_NOT_RECRUITING
Glenn Dale
Dermatology and Skin Cancer Specialists, LLC
ACTIVE_NOT_RECRUITING
Rockville
Michigan
Revival Research Institute, LLC
ACTIVE_NOT_RECRUITING
Troy
Minnesota
University of Minnesota Clinics and Surgery Center Department of Audiology
RECRUITING
Minneapolis
University of Minnesota Clinics and Surgery Center Department of Radiology
RECRUITING
Minneapolis
University of Minnesota Clinics and Surgery Center Department of Radiology
RECRUITING
Minneapolis
University of Minnesota Health Clinical Research Unit (M Health CRU)
RECRUITING
Minneapolis
North Carolina
Clinical & Translational Research Center (CTRC)
ACTIVE_NOT_RECRUITING
Chapel Hill
UNC Dermatology and Skin Cancer Center
ACTIVE_NOT_RECRUITING
Chapel Hill
DJL Clinical Research, PLLC
ACTIVE_NOT_RECRUITING
Charlotte
New York
Icahn School of Medicine at Mount Sinai
ACTIVE_NOT_RECRUITING
New York
Ohio
Bexley Dermatology Research
ACTIVE_NOT_RECRUITING
Bexley
Apex Clinical Research Center - Canton
ACTIVE_NOT_RECRUITING
Canton
Oklahoma
Vital Prospects Clinical Research Institute, PC
RECRUITING
Tulsa
Oregon
Northwest Dermatology Institute
ACTIVE_NOT_RECRUITING
Portland
NW Dermatology Institute
ACTIVE_NOT_RECRUITING
Portland
Oregon Medical Research Center
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
Dermatology Associates of Plymouth Meeting
ACTIVE_NOT_RECRUITING
Plymouth Meeting
South Carolina
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
ACTIVE_NOT_RECRUITING
Charleston
Alliance for Multispecialty Research, LLC
ACTIVE_NOT_RECRUITING
Myrtle Beach
Texas
Arlington Research Center
ACTIVE_NOT_RECRUITING
Arlington
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Bellaire
Dermatology Treatment and Research Center
ACTIVE_NOT_RECRUITING
Dallas
Center for Clinical Studies
RECRUITING
Houston
Texas Dermatology and Laser Specialists
ACTIVE_NOT_RECRUITING
San Antonio
Center for Clinical Studies - Clear Lake
RECRUITING
Webster
Utah
AMR Clinical
ACTIVE_NOT_RECRUITING
Layton
University of Utah
ACTIVE_NOT_RECRUITING
Murray
Washington
Dermatology Specialists of Spokane
ACTIVE_NOT_RECRUITING
Spokane
Principle Research Solutions
ACTIVE_NOT_RECRUITING
Spokane
Other Locations
Canada
SimcoDerm Medical and Surgical Dermatology Center
ACTIVE_NOT_RECRUITING
Barrie
Dermatology Research Institute
ACTIVE_NOT_RECRUITING
Calgary
Guelph Dermatology Research
ACTIVE_NOT_RECRUITING
Guelph
DermEffects
ACTIVE_NOT_RECRUITING
London
Lynderm Research Inc.
ACTIVE_NOT_RECRUITING
Markham
Centre de Recherche Saint-Louis
ACTIVE_NOT_RECRUITING
Montreal
Innovaderm Research Inc.
ACTIVE_NOT_RECRUITING
Montreal
Ryan Clinical Research Inc.
ACTIVE_NOT_RECRUITING
Newmarket
The Centre for Clinical Trials
ACTIVE_NOT_RECRUITING
Oakville
JRB Research Inc.
ACTIVE_NOT_RECRUITING
Ottawa
SKiN Centre for Dermatology
ACTIVE_NOT_RECRUITING
Peterborough
Centre de Recherche Dermatologique du Quebec metropolitain
ACTIVE_NOT_RECRUITING
Québec
Centre de Recherche Saint-Louis
ACTIVE_NOT_RECRUITING
Québec
Centre de Recherche Saint-Louis inc.
ACTIVE_NOT_RECRUITING
Québec
CaRe Clinic
ACTIVE_NOT_RECRUITING
Red Deer
Centre de Recherche Saint-Louis
ACTIVE_NOT_RECRUITING
Sherbrooke
Dermatology on Bloor - Research Toronto
ACTIVE_NOT_RECRUITING
Toronto
Wiseman Dermatology Research Inc.
ACTIVE_NOT_RECRUITING
Winnipeg
China
Beijing Children's hospital, Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Beijing Friendship hospital, Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Beijing Tongren Hospital affiliated to Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
China-Japan Friendship Hospital
ACTIVE_NOT_RECRUITING
Beijing
China-Japan Friendship Hospital
ACTIVE_NOT_RECRUITING
Beijing
Peking University People's Hospital
ACTIVE_NOT_RECRUITING
Beijing
Xiangya Hospital Central South University
ACTIVE_NOT_RECRUITING
Changsha
Chengdu second people's hospital
ACTIVE_NOT_RECRUITING
Chengdu
The Second Affiliated Hospital Chongqing Medical University
ACTIVE_NOT_RECRUITING
Chongqing
The First Affiliated Hospital of Guangzhou Medical University
ACTIVE_NOT_RECRUITING
Guangzhou
Hangzhou Third Hospital
ACTIVE_NOT_RECRUITING
Hangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
ACTIVE_NOT_RECRUITING
Kunming
Jiangxi Provincial Children's Hospital
ACTIVE_NOT_RECRUITING
Nanchang
Nanjing Medical University (NMU) - Jiangsu Province Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Huashan Hospital, Fudan University
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Children's Hospital
RECRUITING
Shanghai
Japan
Hamamatsu University Hospital
ACTIVE_NOT_RECRUITING
Hamamatsu
Juntendo Tokyo Koto Geriatric Medical Center
ACTIVE_NOT_RECRUITING
Koto-ku
Kurume University Hospital
ACTIVE_NOT_RECRUITING
Kurume
Kyorin University Hospital
ACTIVE_NOT_RECRUITING
Mitaka
Niigata University Medical & Dental Hospital
ACTIVE_NOT_RECRUITING
Niigata
Osaka Metropolitan University Hospital
ACTIVE_NOT_RECRUITING
Osaka
Tohoku University Hospital
ACTIVE_NOT_RECRUITING
Sendai
Tokyo Medical University Hospital
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
ACTIVE_NOT_RECRUITING
Gdansk
Centrum Medyczne Angelius Provita
ACTIVE_NOT_RECRUITING
Katowice
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
ACTIVE_NOT_RECRUITING
Krakow
DERMEDIC Iwona Zdybska
ACTIVE_NOT_RECRUITING
Lublin
Twoja Przychodnia NCM
ACTIVE_NOT_RECRUITING
Nowa Sól
DERMEDIC Iwona Zdybska
ACTIVE_NOT_RECRUITING
Ostrowiec Świętokrzyski
Twoja Przychodnia PCM
ACTIVE_NOT_RECRUITING
Poznan
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
ACTIVE_NOT_RECRUITING
Sosnowiec
Twoja Przychodnia - Szczecinskie Centrum Medyczne
ACTIVE_NOT_RECRUITING
Szczecin
Dr Sękowska Leczenie Bólu
ACTIVE_NOT_RECRUITING
Warsaw
Klinika Osipowicz & Turkowski
ACTIVE_NOT_RECRUITING
Warsaw
NZOZ GynCentrum - Oddział Warszawa
ACTIVE_NOT_RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
ACTIVE_NOT_RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
ACTIVE_NOT_RECRUITING
Wroclaw
Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
ACTIVE_NOT_RECRUITING
San Juan
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Dankook University Hospital
ACTIVE_NOT_RECRUITING
Cheonan-si
Kyungpook National University Hospital
ACTIVE_NOT_RECRUITING
Daegu
Jeonbuk National University Hospital
ACTIVE_NOT_RECRUITING
Jeonju
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Seongnam
Konkuk University Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong
ACTIVE_NOT_RECRUITING
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
ACTIVE_NOT_RECRUITING
Seoul
Spain
AUDIKA
ACTIVE_NOT_RECRUITING
Córdoba
Hospital Universitario Reina Sofia
ACTIVE_NOT_RECRUITING
Córdoba
Grupo Pedro Jaén
ACTIVE_NOT_RECRUITING
Madrid
Resonancia Magnetica Nuestra Senora del Rosario
ACTIVE_NOT_RECRUITING
Madrid
CHUS - Hospital Clinico Universitario
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Hospital Universitario Miguel Servet
ACTIVE_NOT_RECRUITING
Zaragoza
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
ACTIVE_NOT_RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
ACTIVE_NOT_RECRUITING
Kaohsiung Niao Sung Dist
Taipei Veterans General Hospital
ACTIVE_NOT_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
ACTIVE_NOT_RECRUITING
Taoyuan
United Kingdom
Ninewells Hospital and Medical School
ACTIVE_NOT_RECRUITING
Dundee
University Hospitals Sussex NHS Foundation Trust
ACTIVE_NOT_RECRUITING
East Sussex
Chelsea and Westminster Hospital NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Guy's & St Thomas' NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Guy's & St Thomas' NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
University Hospitals Sussex NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Worthing
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2028-03-19
Participants
Target number of participants: 1330
Treatments
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.
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.
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.
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 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.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov