RECRUITING

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

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Conditions

Alopecia Areataalopecia universalisalopecia totalisalopeciapatchy hair lossdiffuse hair lossophiasishair diseaseRitlecitinibLitfulohair lossadolescentsadults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-01
Study Completion:2027-03-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06873945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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.
  2. 2. Must meet the following alopecia areata criteria at both Screening and Baseline:
  3. 1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
  4. 2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
  5. 3. Current episode of hair loss ≤10 years.
  1. 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. 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. 3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
  4. 4. General Infection History:
  5. * 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.
  6. * 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.
  7. * Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
  8. 5. Specific Viral Infection History:
  9. * History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
  10. * Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
  11. 6. Other Medical Conditions:
  12. * 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.
  13. * 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.
  14. * 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.
  15. * 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.
  16. * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.
  17. 7. Adolescent participants 12 to \<18 years of age without one of the following:
  18. * Documented evidence from a health professional of having received varicella vaccination (2 doses); or
  19. * Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.
  20. 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.
  21. 9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.
  22. 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.
  23. 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.
  24. 12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
United States
Southern California Clinical Research
Santa Ana, California, 92701
United States
Brett King MD, LLC
Fairfield, Connecticut, 06824
United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912
United States
Robert B. Pritt, DO, PA
Fort Myers, Florida, 33912
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211
United States
Bexley Dermatology Research
Bexley, Ohio, 43209
United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
United States
Oregon Medical Research Center
Portland, Oregon, 97201
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
United States
Alliance for Multispecialty Research, LLC
Myrtle Beach, South Carolina, 29588
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2027-03-09

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2027-03-09

Terms related to this study

Keywords Provided by Researchers

  • alopecia universalis
  • alopecia totalis
  • alopecia
  • patchy hair loss
  • diffuse hair loss
  • ophiasis
  • hair disease
  • Ritlecitinib
  • Litfulo
  • hair loss
  • adolescents
  • adults

Additional Relevant MeSH Terms

  • Alopecia Areata