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A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. This study is seeking participants who have: * previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial. The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home. The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:

• Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031.

• For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.

Locations
United States
California
California Dermatology & Clinical Research Institute
RECRUITING
Encinitas
Florida
Pediatric Skin Research
RECRUITING
Miami
D&H Tamarac Research Center
NOT_YET_RECRUITING
Tamarac
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Maryland
Kindred Hair and Skin Center
NOT_YET_RECRUITING
Marriottsville
Michigan
Michigan Dermatology Institute
NOT_YET_RECRUITING
Waterford
Nebraska
Ear, Nose & Throat Consultants, LLC
RECRUITING
Omaha
Skin Specialists, PC dba Schlessinger MD
RECRUITING
Omaha
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
RECRUITING
Papillion
New Mexico
Regents of the University of New Mexico
RECRUITING
Albuquerque
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
University of New Mexico-IDS Pharmacy
RECRUITING
Albuquerque
New York
Equity Medical, LLC
NOT_YET_RECRUITING
The Bronx
Oregon
Northwest Dermatology Institute
RECRUITING
Portland
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
NOT_YET_RECRUITING
Hershey
South Carolina
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
NOT_YET_RECRUITING
Charleston
Texas
3A Research
RECRUITING
El Paso
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Other Locations
China
Huashan Hospital, Fudan University
RECRUITING
Shanghai
France
Hospices Civils de Lyon - Hopital Femme Mere Enfant
NOT_YET_RECRUITING
Bron
CHU de Dijon Bourgogne
NOT_YET_RECRUITING
Dijon
GHICL - Service d'investigation - Recherche clinique
NOT_YET_RECRUITING
Lille
Hôpital Saint Vincent de Paul
NOT_YET_RECRUITING
Lille
Centre Hospitalier Universitaire de Nice
NOT_YET_RECRUITING
Nice
Hôpitaux Drôme Nord
NOT_YET_RECRUITING
Romans-sur-isère
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
NOT_YET_RECRUITING
Toulouse
Japan
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Kyorin University Hospital
NOT_YET_RECRUITING
Mitaka
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Tohoku University Hospital
NOT_YET_RECRUITING
Sendai
Poland
Centrum Medyczne Angelius Provita
NOT_YET_RECRUITING
Katowice
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
NOT_YET_RECRUITING
Lodz
DERMEDIC Iwona Zdybska
NOT_YET_RECRUITING
Lublin
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Klinika Ambroziak Dermatologia
NOT_YET_RECRUITING
Warsaw
Klinika Osipowicz & Turkowski
NOT_YET_RECRUITING
Warsaw
Państwowy Instytut Medyczny MSWiA
NOT_YET_RECRUITING
Warsaw
Provita Poliklinika
NOT_YET_RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
NOT_YET_RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2030-06-26
Participants
Target number of participants: 140
Treatments
Experimental: Ritlecitinib higher dose
Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years.~Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study.~Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
Experimental: Ritlecitinib lower dose
Participants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years.~Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study.~Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov