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

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Ritlecitinib; Drug: Ritlecitinib 100 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • The Skin Hospital
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • North Eastern Health Specialists
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc.
    • East Melbourne, Victoria, Australia, 3002
      • Dr Rodney Sinclair Pty Ltd
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Bulgaria
  • Stara Zagora, Bulgaria, 6003
    • UMHAT "Prof. Dr. Stoyan Kirkovich"AD
  • Kyustendil
    • Dupnitsa, Kyustendil, Bulgaria, 2600
      • Medical Centre "Asklepiy"
  • Sofia (stolitsa)
    • Sofia, Sofia (stolitsa), Bulgaria, 1431
      • Diagnostic Consultative Center Aleksandrovska
• Canada
  • Québec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique du Quebec metropolitain
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis inc.
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute
    • Red Deer, Alberta, Canada, T4P 1K4
      • CaRe Clinic
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research
    • Toronto, Ontario, Canada, M2N3A6
      • North York Research Inc
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • The First Hospital of Wuhan
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University/Dermatology and STD Department
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Fudan University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
• Germany
  • Baden-Wurttemberg
    • Stuttgart, Baden-Wurttemberg, Germany, 70178
      • Praxis Leitz und Kollegen
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Osaka
    • Sakai, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-8506
      • Yamanashi Prefectural Central Hospital
• Mexico
  • Veracruz, Mexico, 91900
    • Sociedad de Metabolismo y Corazón S.C.
  • Veracruz, Mexico, 91900
    • Arké SMO S.A de C.V
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06720
      • Hospital Infantil de Mexico Federico Gomez
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Centro de Dermatologia de Monterrey
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Osielsko, Kuyavian-Pomeranian Voivodeship, Poland, 86-031
      • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Royalderm Agnieszka Nawrocka
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
      • Twoja Przychodnia SCM
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-436
      • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
  • Świętokrzyskie Voivodeship
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • DERMEDIC Jacek Zdybski
• South Korea
  • Kyǒnggi-do
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Kyǒnggi-do, South Korea, 16247
      • The Catholic University of Korea St. Vincent's Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Severance Hospital, Yonsei University Health System
• Spain
  • Córdoba, Spain, 14001
    • AUDIKA
  • Andalusia
    • Córdoba, Andalusia, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Catalunya [cataluña]
    • Barcelona, Catalunya [cataluña], Spain, 08036
      • Hospital Clinic de Barcelona
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrín
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramon y Cajal
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi Cerrahpasa
  • Kayseri, Turkey (Türkiye)
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri
  • Manisa, Turkey (Türkiye), 45030
    • Celal Bayar University Hafsa Sultan Hospital
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34899
      • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's & St Thomas' NHS Foundation Trust
• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group, Inc
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Encore Medical Research of Boynton Beach
    • Hollywood, Florida, United States, 33021
      • Skin Care Research
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J. Green, MD LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Health Sciences Center
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Health Sciences University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina Medical Center
    • Chapel Hill, North Carolina, United States, 27599
      • Clinical & Translational Research Center (CTRC)
    • Wilmington, North Carolina, United States, 28411
      • Accellacare - Wilmington
    • Wilmington, North Carolina, United States, 28411
      • Wilmington Health, PLLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research
    • Houston, Texas, United States, 77008
      • Alpesh D. Desai, DO PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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; Ritlecitinib 50 mg capsule once daily; Drug: Ritlecitinib 100 mg; Ritlecitinib 100 mg capsule once daily; Drug: Placebo; Matching capsule once daily
Experimental: Arm 2; 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; Ritlecitinib 50 mg capsule once daily; Drug: Ritlecitinib 100 mg; Ritlecitinib 100 mg capsule once daily; Drug: Placebo; Matching capsule once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline	Baseline to week 52
Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline	Baseline to Week 52
Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline	Baseline to week 52
Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline	Baseline to week 52
Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline	Baseline to week 52
Proportion of participants achieving disease stabilization	The difference in the proportion of participants with stable disease at all scheduled timepoints	Baseline to week 52
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline	Baseline to week 52
Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline	Baseline to week 52
Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline	Baseline to week 52
Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52	Baseline to week 52
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52	Baseline to week 52
Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52	Baseline to week 52
Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52	Baseline to week 52
Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52	To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo	Baseline to week 52
Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52	To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo	Baseline to week 52
Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).	To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo	Baseline to week 52

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Adults; Stable vitiligo; Active vitiligo
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: B7981041; 2023-505804-42-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No