A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo

NCT05583526 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: B7981040Tranquillo2022-501668-16-00
• Study Type: interventional
• Target: 607
• Locations: 15 countries
• Sites: 115

Brief Summary

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo

Conditions

Active Nonsegmental Vitiligo; Stable Nonsegmental Vitiligo

Outcome Measures

Primary Outcomes (3)

• US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52

  Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)

  Week 52

• Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52

  Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)

  Week 52

• Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities

  Safety and tolerability of ritlecitinib in participants with nonsegmental vitiligo

  Baseline through Week 52

Secondary Outcomes (35)

• US-Only: Response based on F-VASI75 at 24 and 36 weeks

  Weeks 24 and 36

• US-Only: Response based on T-VASI50 at 24 and 36 weeks

  Weeks 24 and 36

• US-Only: Response based on T-VASI75 at 52 weeks

  Week 52

• US-Only: Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks

  Weeks 24, 36, and 52

• US-Only: Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks

  Weeks 24, 36, and 52

Study Arms (2)

Ritlecitinib 50 mg

EXPERIMENTAL

Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)

Drug: Ritlecitinib

Placebo

PLACEBO COMPARATOR

Placebo (placebo arm; approximately 200 participants)

Drug: Placebo

Interventions

Placebo DRUG

Matching capsule

Placebo

Ritlecitinib DRUG

50 mg capsule

Ritlecitinib 50 mg

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. Adolescents (12 to \<18 years of age) are also eligible for this study, but only if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.
• Disease Characteristics:
• Eligible participants must have at both Screening and Baseline:
• A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
• BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and
• BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids; and
• F-VASI ≥0.5 \& T-VASI ≥3; and
• Either active or stable disease nonsegmental vitiligo at both Screening and Baseline visits. All participants who do not have the features of active vitiligo (defined below) are required to have stable disease.
• Active vitiligo is defined as:
• Participants will be classified as having active vitiligo based on the presence of at least one active lesion at baseline defined as one of the following:
• New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record):
• Confetti-like lesion(s); Confetti-like depigmentation is characterized by the presence of numerous 1-mm to 5-mm depigmented macules in clusters;
• Trichrome lesion(s);Trichrome lesions have a hypopigmented zone of varying width between normal and completely depigmented skin, resulting in 3 different hues of skin;
• Koebner phenomenon/phenomena (excluding Type 1 \[history based on isomorphic reaction\]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement.
• Stable vitiligo is defined as an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) are required to have stable disease.

You may not qualify if:

• Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
• Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening visit.
• Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
• For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.
• Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
• Currently have active forms of other disorders of pigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma (all types, including mixed), and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
• Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
• Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions.
• Have a superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
• General Infection History:
• Having a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
• 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.
• Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB
• Specific Viral Infection History:
• History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (115)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham Faculty Office Towers (Regulatory

Birmingham, Alabama, 35294, United States

Location

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

Audiology

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, 20037, 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

Clever Medical Research

Miami, Florida, 33126, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

Location

Olympian Clinical Research

St. Petersburg, Florida, 33709, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Advanced Medical Research, PC.

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

The NeuroMedical Center (XRay)

Baton Rouge, Louisiana, 70810, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Prairieville Family Hospital (XRay)

Prairieville, Louisiana, 70769, United States

Location

Visage Dermatology and Aesthetic Center

Bowie, Maryland, 20716, United States

Location

Lawrence J Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hamzavi Dermatology - Canton

Canton, Michigan, 48187, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, 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

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, 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

Accellacare

Wilmington, North Carolina, 28411, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28411, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Remington Davis Clinical Research

Columbus, Ohio, 43215, United States

Location

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

Alpesh D. Desai, DO PLLC - Research

Houston, Texas, 77008, United States

Location

Austin Institute for Clinical Research

Houston, Texas, 77056, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, 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

MC "Asklepiy" OOD

Dupnitsa, 2600, Bulgaria

Location

DCC Aleksandrovska EOOD

Sofia, 1431, Bulgaria

Location

UMHAT "Prof. dr. Stoyan Kirkovich" AD

Stara Zagora, 6000, 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

Whitby Health Centre Dermatology trials

Whitby, Ontario, L1P 0p9, 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

Fujian Medical University Affiliated First Hospital

Fuzhou, Fujian, 350005, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, 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

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Zhejiang Provincial People's Hospital/Dermatology Department

Hangzhou, Zhejiang, 310014, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

The first Affiliated hospital of Wenzhou medical University

Wenzhou, Zhejiang, 325000, China

Location

Praxis Leitz und Kollegen

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Istituto Clinico Humanitas, IRCCS

Rozzano, Milano, 20089, Italy

Location

Istituti Fisioterapici Ospitalieri (IFO)

Roma, RM, 00144, Italy

Location

Policlinico S. Orsola- Malpighi

Bologna, 40138, Italy

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

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Sugamo Kobayashi Derma Clinic

Toshima-Ku, Tokyo, 170-0002, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, 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

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico

Location

Sociedad de Metabolismo Y Corazon Sc

Veracruz, 91900, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91910, 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 Witokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

Clinresco Centres

Kempton Park, Gauteng, 1619, South Africa

Location

Botho Ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa

Location

Task Central

Cape Town, Western Cape, 7530, South Africa

Location

Dongguk University Ilsan Hospital

Goyang-si, Kyǒnggi-do, 10326, South Korea

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 Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

AUDIKA

Córdoba, 14001, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34890, Turkey (Türkiye)

Location

Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, 38039, Turkey (Türkiye)

Location

Celal Bayar Universitesi Hafta Sultan Hastanesi

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.

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

Model Details: Double-blind, parallel-group, vehicle controlled.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 17, 2022
• Study Start: December 1, 2022
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (11); AU (5); JP (7); ES (5); ZA (4); DE (4); US (46); CA (8); KR (4); IT (3); TU (4); PL (5); GB (1); BU (3); ME (5)