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ACTIVE NOT RECRUITING
NCT06072183
PHASE3

A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: * Are 18 years of age or older. * are confirmed to have nonsegmental vitiligo for at least 3 months. * Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: * vitiligo rating, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG, * photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.

Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1571

Start Date

2023-11-08

Completion Date

2027-07-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Ritlecitinib

100mg Capsule

DRUG

Ritlecitinib

50mg Capsule

DRUG

Placebo

Matching capsule

Locations (228)

Center for Dermatology and Plastic Surgery/CCT Research

Scottsdale, Arizona, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

First OC Dermatology Research Inc

Fountain Valley, California, United States

Seaside Audiology Vertigo & Ear Specialists

Huntington Beach, California, United States

Wallace Medical Group, Inc

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

Cura Clinical Research - Oxnard

Oxnard, California, United States

Mission Dermatology Center

Rancho Santa Margarita, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

University of California San Diego - La Jolla

San Diego, California, United States

Wolverine Clinical Trials

Santa Ana, California, United States

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, United States

FXM Clinical Research - Fort Lauderdale

Fort Lauderdale, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Clever Medical Research

Miami, Florida, United States

Miami Dermatology and Laser Research

Miami, Florida, United States

SouthCoast Research Center

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Bio-Medical Research LLC

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Skin Research of South Florida

Miami, Florida, United States

Well Pharma Medical Research, Corp.

Miami, Florida, United States

FXM Clinical Research - Miami

Miami, Florida, United States

Health and Life Research Institute

Miami, Florida, United States

University of Miami, Kendall Office

Miami, Florida, United States

Floridian Research Institute Llc

Miami, Florida, United States

Sanitas Research

Miami, Florida, United States

Wellness Clinical Research

Miami Lakes, Florida, United States

FXM Clinical Research - Miramar

Miramar, Florida, United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida, United States

Advanced Clinical Research Institute

Tampa, Florida, United States

USF Health

Tampa, Florida, United States

Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic

Savannah, Georgia, United States

Endeavor Health Audiology -CHICAGO

Chicago, Illinois, United States

Endeavor Health Audiology -LAKE BLUFF

Lake Bluff, Illinois, United States

Endeavor Health Audiology-NORTHBROOK

Northbrook, Illinois, United States

Endeavor Health Audiology-SKOKIE

Skokie, Illinois, United States

Endeavor Health-Dermatology Clinical Trials Unit

Skokie, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The South Bend Clinic, LLC

South Bend, Indiana, United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

CS Mott Center

Detroit, Michigan, United States

Wayne Health

Detroit, Michigan, United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

OptiSkin Medical

New York, New York, United States

DermResearchCenter of New York, Inc.

Stony Brook, New York, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Darst Dermatology

Charlotte, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Columbia Dermatology & Aesthetics

Columbia, South Carolina, United States

Palmetto Clinical Trial Services - Greenville

Greenville, South Carolina, United States

Center for Clinical Studies

Houston, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Complete Dermatology

Sugar Land, Texas, United States

The Woodlands Dermatology Associates, PA

The Woodlands, Texas, United States

University of Utah

Murray, Utah, United States

Springville Dermatology - Springville/CCT Research

Springville, Utah, United States

Eurofins CRL

Forest, Virginia, United States

Paratus Clinical Research Woden

Phillip, Australian Capital Territory, Australia

St George Dermatology & Skin Cancer Centre

Kogarah, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia

North Eastern Health Specialists

Campbelltown, South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Dr Rodney Sinclair Pty Ltd

East Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Institute for Skin, Health and Immunity

Mitcham, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Bruxelles-capitale, Région de, Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-capitale, Région de, Belgium

UZ Gent

Ghent, Oost-vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

ASMC - IPSMC - skin and venereal diseases

Sofia, Sofia (stolitsa), Bulgaria

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), Bulgaria

Diagnostic Consultative Centre (DCC) - Foкus 5

Sofia, Sofia (stolitsa), Bulgaria

Clinic EvroDerma

Sofia, Sofia (stolitsa), Bulgaria

MHAT Pazardzhik

Pazardzhik, Bulgaria

Diagnostic Consultative Center 1 - Pernik

Pernik, Bulgaria

Medical Center Exacta Medica

Pleven, Bulgaria

Medical Center Prolet EOOD

Rousse, Bulgaria

Diagnostic Consultative Center "Ascendent"

Sofia, Bulgaria

Diagnostic - Consultative Center XXVIII - Sofia

Sofia, Bulgaria

"Diagnostic - Consultative Center XX - Sofia" EOOD

Sofia, Bulgaria

UMHAT "Prof. Dr. Stoyan Kirkovich"AD

Stara Zagora, Bulgaria

Center for Skin and Venereal Diseases - Veliko Tarnovo

Veliko Tarnovo, Bulgaria

Multiprofile Hospital for Active Treatment Sv. Panteleymon - Yambol AD

Yambol, Bulgaria

Dermatology Research Institute

Calgary, Alberta, Canada

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada

The Skin Care Centre

Vancouver, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

Sudbury Skin Clinique

Greater Sudbury, Ontario, Canada

DermEffects

London, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

The Centre for Clinical Trials

Oakville, Ontario, Canada

JRB Research Inc.

Ottawa, Ontario, Canada

York Dermatology Clinic & Research Centre

Richmond Hill, Ontario, Canada

North York Research Inc

Toronto, Ontario, Canada

Dermatology on Bloor - Research Toronto

Toronto, Ontario, Canada

Centre de Recherche Saint-Louis

Montreal, Quebec, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Centre de Recherche Saint-Louis

Sherbrooke, Quebec, Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

Diex Recherche Quebec

Québec, Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Canada

Alpha Recherche Clinique

Québec, Canada

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NanYang First people's hospital

Nanyang, Henan, China

The First Hospital of Wuhan

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Chengdu second people's hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Hangzhou Third Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Shanghai General Hospital

Shanghai, China

Rosenpark Research GmbH

Darmstadt, Hesse, Germany

Klinikum Bielefeld gem. GmbH

Bielefeld, North Rhine-Westphalia, Germany

Klinikum Bielefeld Rosenhöhe

Bielefeld, North Rhine-Westphalia, Germany

Hautzentrum im Jahrhunderthaus

Bochum, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

BAG Drs. Med. Quist PartG

Mainz, Rhineland-Palatinate, Germany

Hautarztpraxis Dr. Beatrice Gerlach

Dresden, Saxony, Germany

Hautarztpraxis Dr. Neubauer

Leipzig, Saxony, Germany

HNO-Praxis Dr. Kugler in Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Magdeburger Company for Medical Studies and Services

Magdeburg, Saxony-Anhalt, Germany

Radiologie Ulrichshaus

Magdeburg, Saxony-Anhalt, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, Hungary

Trial Pharma - Semper Medical Center

Békéscsaba, Hungary

Óbudai Egészségügyi Centrum

Budapest, Hungary

Orvostudomanyi Kutato es Fejleszto Kft

Debrecen, Hungary

DERMA-B Egészségügyi és Szolgáltató

Debrecen, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Derm-Surg Egészségügyi Szolgáltató és Tanácsadó Kft.

Kaposvár, Hungary

ASL1 Avezzano-Sulmona-L'Aquila

L’Aquila, Abruzzo, Italy

Presidio Ospedaliero Firenze Centro Piero Palagi

Florence, Firenze, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

IRCCS Istituti Fisioterapici Ospitalieri

Roma, RM, Italy

Ospedale Israelitico

Rome, ROMA, Italy

Istituto Dermopatico Immacolata

Rome, ROMA, Italy

Ospedale Civile - Azienda Ospedaliera Universitaria di Cagliari

Cagliari, Italy

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Aichi-ken, Japan

Toho University Sakura Medical Center

Sakura, Chiba, Japan

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Takarazuka City Hospital

Takarazuka, Hyōgo, Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

Kindai University Nara Hospital

Ikoma, Nara, Japan

Osaka Habikino Medical Center

Habikino, Osaka, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Trials in Medicine

Mexico City, Mexico City, Mexico

Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC

Morelia, Michoacán, Mexico

Cri Centro Regiomontano de Investigacion

Monterrey, Nuevo León, Mexico

Servicios Hospitalarios de Mexico S.A. DE C.V.

Chihuahua City, Mexico

Arké SMO S.A de C.V

Veracruz, Mexico

Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny I Alergologiczny Prof.Dr Hab.Med. Barbara Z

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka

Krakow, Lesser Poland Voivodeship, Poland

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship, Poland

ETG Warszawa

Warsaw, Masovian Voivodeship, Poland

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, Poland

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, Poland

Specderm Poznanska sp.j.

Bialystok, Podlaskie Voivodeship, Poland

ClinicMed Daniluk, Nowak Spółka komandytowa

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, Poland

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, Łódź Voivodeship, Poland

Cardiovascular Radiology Institute

San Juan, Puerto Rico

Clinical Research Puerto Rico

San Juan, Puerto Rico

Centro de Audiología y Balance

San Juan, Puerto Rico

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

Banská Bystrica, Banská Bystrica Region, Slovakia

SANARE, s.r.o

Svidník, Presov, Slovakia

Fakultna nemocnica Trnava

Trnava, Trnava Region, Slovakia

CLINIQ s.r.o.

Bratislava, Slovakia

BeneDerma

Bratislava, Slovakia

Derma therapy spol. s.r.o.

Bratislava, Slovakia

Poliklinika ProCare Kosice s.r.o.

Košice, Slovakia

Topskin pro s.r.o.

Košice, Slovakia

AUDIKA

Córdoba, Andalusia, Spain

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona [barcelona], Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona [barcelona], Spain

Clínica Gaias - Santiago

Santiago de Compostela, Galicia [galicia], Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Comunidad de, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Clínica Gaias - Santiago

Santiago de Compostela, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Gazi University Health Research and Application Center Gazi Hospital

Ankara, Turkey (Türkiye)

Bezmialem Vakf Üniversitesi

Istanbul, Turkey (Türkiye)

West Middlesex University Hospital

Isleworth, England, United Kingdom

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, London, CITY of, United Kingdom