B7981094 Enrolling

Alopecia Areata Study (57 Weeks)


Treatment: Oral Age: 12+ Years


Who Can Participate?

Adolescents and adults aged 18 and above with AA may participate.

 

Inclusion Criteria

  • have a clinical diagnosis of AA with no other etiology of hair loss
  • have ≥ 50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
  • have current episode of hair loss ≤ 10 years 

 

Participant Information 

  • Participate and receive study treatment at no cost
  • Regular visits with study doctors who specialise in treating alopecia areata (10 visits)
  • Will receive an investigative oral treatment (study drug)
  • Reimbursement for study-related expenses may be provided

How Long Will The Study Last?

  • 57 weeks

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: April 30, 2025

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

ClinicalTrials.gov ID

NCT06873945

Sponsor

Pfizer

Study Description

  • Brief 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.

  • Condition or Disease:

    Alopecia Areata

  • Intervention/Treatment:

    Drug: Ritlecitinib 100 mg,Drug: Placebo - 50 mg Drug: Ritlecitinib 50 mg,Drug: Placebo - 100 mg undefined undefined
  • Phase:

    PHASE 3

  • Ages Eligible for Study:

    12 Years and older (CHILD,ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Inclusion Criteria

  • have a clinical diagnosis of AA with no other etiology of hair loss
  • have ≥ 50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
  • have current episode of hair loss ≤ 10 years 

Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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