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 (113) 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 * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

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.

• 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
Arkansas
Burke Pharmaceutical Research
RECRUITING
Hot Springs
California
Doc1 Healthcare Systems
RECRUITING
Brea
California Dermatology & Clinical Research Institute
NOT_YET_RECRUITING
Encinitas
Marvel Clinical Research
RECRUITING
Huntington Beach
Southern California Clinical Research
RECRUITING
Santa Ana
Connecticut
Brett King MD, LLC
RECRUITING
Fairfield
Florida
Alliance for Multispecialty Research, LLC
RECRUITING
Fort Myers
Robert B. Pritt, DO, PA
RECRUITING
Fort Myers
Solutions Through Advanced Research
RECRUITING
Jacksonville
Pediatric Skin Research
NOT_YET_RECRUITING
Miami
Skin Research of South Florida
RECRUITING
Miami
ForCare Clinical Research
RECRUITING
Tampa
Olympian Clinical Research - Tampa - Memorial Highway
RECRUITING
Tampa
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Illinois
Endeavor Health
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
NOT_YET_RECRUITING
Indianapolis
Indiana University Health University Hospital Adult Outpatient Center
NOT_YET_RECRUITING
Indianapolis
Indiana University School of Medicine - Indiana CTSI Clinical Research Center
NOT_YET_RECRUITING
Indianapolis
Sidney & Lois Eskenazi Health Center
NOT_YET_RECRUITING
Indianapolis
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Maryland
Callender Center for Clinical Research
NOT_YET_RECRUITING
Glenn Dale
Dermatology and Skin Cancer Specialists, LLC
RECRUITING
Rockville
Michigan
Revival Research Institute, LLC
RECRUITING
Troy
North Carolina
Clinical & Translational Research Center (CTRC)
RECRUITING
Chapel Hill
University of North Carolina Medical Center
RECRUITING
Chapel Hill
DJL Clinical Research, PLLC
RECRUITING
Charlotte
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Bexley Dermatology Research
RECRUITING
Bexley
Apex Clinical Research Center - Canton
RECRUITING
Canton
Oklahoma
Vital Prospects Clinical Research Institute, PC
RECRUITING
Tulsa
Oregon
Northwest Dermatology Institute
NOT_YET_RECRUITING
Portland
NW Dermatology Institute
NOT_YET_RECRUITING
Portland
Oregon Medical Research Center
RECRUITING
Portland
Pennsylvania
Dermatology Associates of Plymouth Meeting
RECRUITING
Plymouth Meeting
South Carolina
Alliance for Multispecialty Research, LLC
RECRUITING
Myrtle Beach
Texas
Arlington Research Center
RECRUITING
Arlington
Dermatology Treatment and Research Center
NOT_YET_RECRUITING
Dallas
Center for Clinical Studies
RECRUITING
Houston
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Center for Clinical Studies - Clear Lake
RECRUITING
Webster
Utah
AMR Clinical
RECRUITING
Layton
University of Utah
NOT_YET_RECRUITING
Murray
Washington
Dermatology Specialists of Spokane
NOT_YET_RECRUITING
Spokane
Principle Research Solutions
NOT_YET_RECRUITING
Spokane
Other Locations
Canada
SimcoDerm Medical and Surgical Dermatology Center
RECRUITING
Barrie
Guelph Dermatology Research
RECRUITING
Guelph
DermEffects
RECRUITING
London
Lynderm Research Inc.
RECRUITING
Markham
Centre de Recherche Saint-Louis
RECRUITING
Montreal
Innovaderm Research Inc.
RECRUITING
Montreal
Ryan Clinical Research Inc.
RECRUITING
Newmarket
The Centre for Clinical Trials
RECRUITING
Oakville
JRB Research Inc.
RECRUITING
Ottawa
SKiN Centre for Dermatology
RECRUITING
Peterborough
Centre de Recherche Dermatologique du Quebec metropolitain
RECRUITING
Québec
Centre de Recherche Saint-Louis inc.
RECRUITING
Québec
CaRe Clinic
RECRUITING
Red Deer
Centre de Recherche Saint-Louis
RECRUITING
Sherbrooke
Research Toronto
RECRUITING
Toronto
Wiseman Dermatology Research Inc.
NOT_YET_RECRUITING
Winnipeg
China
Beijing Children's hospital, Capital Medical University
RECRUITING
Beijing
Beijing Friendship hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tongren Hospital affiliated to Capital Medical University
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Chengdu Second Municipal People's Hospital
RECRUITING
Chengdu
2nd Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Guangzhou Medical College
RECRUITING
Guangzhou
Hangzhou Third Hospital
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Jiangxi Provincial Children's Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing Medical University (NMU) - Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Shanghai Children's Hospital
NOT_YET_RECRUITING
Shanghai
Japan
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Juntendo Tokyo Koto Geriatric Medical Center
RECRUITING
Koto-ku
Kurume University Hospital
RECRUITING
Kurume
Kyorin University Hospital
RECRUITING
Mitaka
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Tohoku University Hospital
RECRUITING
Sendai
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
RECRUITING
Krakow
DERMEDIC Iwona Zdybska
RECRUITING
Lublin
Twoja Przychodnia NCM
RECRUITING
Nowa Sól
Twoja Przychodnia PCM
RECRUITING
Poznan
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
Klinika Osipowicz & Turkowski
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Dankook University Hospital
RECRUITING
Cheonan-si
Jeonbuk National University Hospital
RECRUITING
Jeonju
Kyungpook National University Hospital
RECRUITING
Junggu
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Boramae Medical Center
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Spain
AUDIKA
NOT_YET_RECRUITING
Córdoba
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
NOT_YET_RECRUITING
Kaohsiung Niao Sung Dist
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan District
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: 2027-03-09
Participants
Target number of participants: 550
Treatments
Experimental: Ritlecitinib 100 mg
Randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Experimental: Ritlecitinib 50 mg
Randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks.~In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
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.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

Similar Clinical Trials