A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

NCT06163326 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B79810412023-505804-42-00
• Study Type: interventional
• Target: 394
• Locations: 13 countries
• Sites: 73

Brief Summary

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:

• if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
• Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
• Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who:
• have non-segmental vitiligo (either active or stable) and
• received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.

Conditions

Vitiligo

Keywords

Stable vitiligo; Active vitiligo; Adults; Adolescents

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation

  To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

  Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

• Incidence of clinically significant laboratory abnormalities

  To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

  Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

Secondary Outcomes (16)

• Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52

  Baseline to week 52

• Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52

  Baseline to week 52

• Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52

  Baseline to Week 52

• Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52

  Baseline to week 52

• Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52

  Baseline to week 52

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.

Drug: Ritlecitinib; Drug: Ritlecitinib 100 mg; Drug: Placebo

Arm 2

EXPERIMENTAL

Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned

Drug: Ritlecitinib; Drug: Ritlecitinib 100 mg; Drug: Placebo

Interventions

Ritlecitinib DRUG

Ritlecitinib 50 mg capsule once daily

Arm 1; Arm 2

Ritlecitinib 100 mg DRUG

Ritlecitinib 100 mg capsule once daily

Arm 1; Arm 2

Placebo DRUG

Matching capsule once daily

Arm 1; Arm 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to \<18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
• Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
• The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

You may not qualify if:

• Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
• Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Wallace Medical Group, Inc

Los Angeles, California, 90056, United States

Location

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Skin Care Research

Hollywood, Florida, 33021, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

Location

SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27516, United States

Location

Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28411, United States

Location

Wilmington Health, PLLC

Wilmington, North Carolina, 28411, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

Alpesh D. Desai, DO PLLC

Houston, Texas, 77008, United States

Location

Austin Institute for Clinical Research

Houston, Texas, 77056, United States

Location

The Skin Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

North Eastern Health Specialists

Campbelltown, South Australia, 5074, Australia

Location

Skin Health Institute Inc.

Carlton, Victoria, 3053, Australia

Location

Dr Rodney Sinclair Pty Ltd

East Melbourne, Victoria, 3002, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Medical Centre "Asklepiy"

Dupnitsa, Kyustendil, 2600, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), 1431, Bulgaria

Location

UMHAT "Prof. Dr. Stoyan Kirkovich"AD

Stara Zagora, 6003, Bulgaria

Location

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

Location

CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

North York Research Inc

Toronto, Ontario, M2N3A6, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, G1V 4X7, Canada

Location

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

The First Hospital of Wuhan

Wuhan, Hubei, 430022, China

Location

The First Hospital of China Medical University/Dermatology and STD Department

Shenyang, Liaoning, 110001, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Praxis Leitz und Kollegen

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City, 06720, Mexico

Location

Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91900, Mexico

Location

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico

Location

DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, 71-500, Poland

Location

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

The Catholic University Of Korea St. Vincent's Hospital

Suwon, Kyǒnggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Kyǒnggi-do, 16499, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

Location

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña], 08036, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

Location

AUDIKA

Córdoba, 14001, Spain

Location

Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Istanbul, İ̇stanbul, 34899, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, Turkey (Türkiye)

Location

Celal Bayar University Hafsa Sultan Hospital

Manisa, 45030, Turkey (Türkiye)

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BU (3); DE (3); CN (5); JP (6); KR (3); TU (4); ME (4); CA (7); GB (1); AU (5); US (22); PL (5); ES (5)