Can a daily pill bring back skin color? new trial tests ritlecitinib for vitiligo

NCT ID NCT05583526

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested ritlecitinib, an oral drug, in 607 adults and adolescents with nonsegmental vitiligo (a type of white patches on the skin). Participants took either the drug or a placebo daily for 52 weeks. The main goals were to see if the drug could improve skin color on the face and body, and to check for side effects. The trial is complete, and results will show if ritlecitinib is a safe and effective treatment for vitiligo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Ritlecitinib (oral capsule)
What this could lead to: If successful, ritlecitinib could become a new treatment option to restore skin color in people with nonsegmental vitiligo.
What could go wrong: This is a Phase 3 trial, but results are not yet published. The drug may not work for everyone, and side effects are possible. It is not a cure, as ongoing treatment may be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

607 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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: 2. 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. Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA. Other Inclusion Criteria: 3. If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study. 4. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit. Exclusion Criteria: 1. 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. 2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin: * Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo). * 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. 3. 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 4. 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. * Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. * Participants who are positive for HCVAb and HCV RNA will not be eligible for this study. * Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency. 5. Medical Conditions, Other: * Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements. * History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention. * Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive. * Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. * Abnormal findings on the Screening chest imaging (eg, chest x-ray) that may increase the risk associated with study participation including, but not limited to, presence of active TB, general infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening. Documentation of the official reading must be located and available in the source documentation. * Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP. * Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study. Prior/Concomitant Therapy: 6. Have received any of the prohibited treatment regimens specified. Prior/Concurrent Clinical Study Experience: 7. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 \[Baseline\] or within 5 half-lives, whichever is longer. Diagnostic Assessments: 8. Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat: * Renal impairment * Hepatic dysfunction 9. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities Other Exclusion Criteria: 10. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. 11. Adolescent participants 12 to \<18 years of age without one of the following: * Documented evidence from a health professional of having received varicella vaccination (2 doses); or * Evidence of prior exposure to VZV based on serological testing (ie, a positive VZV IgG Ab result) at Screening.

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Conditions

The condition(s) this trial relates to.

vitiligo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Active nonsegmental vitiligo Stable nonsegmental vitiligo

Contacts and locations

Locations

AUDIKA

Córdoba, 14001, Spain
Accellacare

Wilmington, North Carolina, 28411, United States
Accellacare - Wilmington

Wilmington, North Carolina, 28411, United States
Advanced Medical Research, PC.

Sandy Springs, Georgia, 30328, United States
Ajou University Hospital

Suwon, Kyǒnggi-do, 16499, South Korea
Alpesh D. Desai, DO PLLC - Research

Houston, Texas, 77008, United States
Arké SMO S.A de C.V

Veracruz, 91910, Mexico
Audiology

Washington D.C., District of Columbia, 20007, United States
Austin Institute for Clinical Research

Houston, Texas, 77056, United States
Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States
Botho Ke Bontle Health Services

Pretoria, Gauteng, 0184, South Africa
CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada
California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States
Celal Bayar Universitesi Hafta Sultan Hastanesi

Manisa, 45030, Turkey (Türkiye)
Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, 20037, United States
Centre de Recherche Dermatologique du Quebec metropolitain

Québec, G1V 4X7, Canada
Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada
Centro de Dermatologia de Monterrey

Monterrey, Nuevo León, 64460, Mexico
Clever Medical Research

Miami, Florida, 33126, United States
Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599, United States
Clinresco Centres

Kempton Park, Gauteng, 1619, South Africa
DCC Aleksandrovska EOOD

Sofia, 1431, Bulgaria
Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States
DelRicht Research

Baton Rouge, Louisiana, 70809, United States
DelRicht Research

New Orleans, Louisiana, 70115, United States
DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada
Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States
Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China
Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada
Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan
Dermedic Jacek Zdybski

Ostrowiec Witokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland
Dongguk University Ilsan Hospital

Goyang-si, Kyǒnggi-do, 10326, South Korea
Dr Rodney Sinclair Pty Ltd

East Melbourne, Victoria, 3002, Australia
Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436, United States
Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, 38039, Turkey (Türkiye)
Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany
First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
ForCare Clinical Research

Tampa, Florida, 33613, United States
Fujian Medical University Affiliated First Hospital

Fuzhou, Fujian, 350005, China
Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China
Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom
Hamzavi Dermatology - Canton

Canton, Michigan, 48187, United States
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City, 06720, Mexico
Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain
Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)
Istituti Fisioterapici Ospitalieri (IFO)

Roma, RM, 00144, Italy
Istituto Clinico Humanitas, IRCCS

Rozzano, Milano, 20089, Italy
Lawrence J Green, MD LLC

Rockville, Maryland, 20850, United States
Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada
MC "Asklepiy" OOD

Dupnitsa, 2600, Bulgaria
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34890, Turkey (Türkiye)
Marvel Clinical Research

Huntington Beach, California, 92647, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Modern Research Associates, PLLC

Dallas, Texas, 75231, United States
Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan
Nippon Medical School Hospital

Tokyo, 113-8603, Japan
North Eastern Health Specialists

Campbelltown, South Australia, 5074, Australia
North York Research Inc

Toronto, Ontario, M2N3A6, Canada
Olympian Clinical Research

St. Petersburg, Florida, 33709, United States
PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28411, United States
Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa
Policlinico S. Orsola- Malpighi

Bologna, 40138, Italy
Prairieville Family Hospital (XRay)

Prairieville, Louisiana, 70769, United States
Praxis Leitz und Kollegen

Stuttgart, Baden-Wurttemberg, 70178, Germany
Progressive Clinical Research

San Antonio, Texas, 78213, United States
Remington Davis Clinical Research

Columbus, Ohio, 43215, United States
Remington-Davis, Inc

Columbus, Ohio, 43215, United States
Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, 02-962, Poland
SUNY Downstate Health Sciences University

Brooklyn, New York, 11203, United States
Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China
Skin Care Research

Hollywood, Florida, 33021, United States
Skin Health Institute Inc.

Carlton, Victoria, 3053, Australia
Skin Specialists, PC

Omaha, Nebraska, 68144, United States
Sociedad de Metabolismo Y Corazon Sc

Veracruz, 91900, Mexico
Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91900, Mexico
Sugamo Kobayashi Derma Clinic

Toshima-Ku, Tokyo, 170-0002, Japan
Task Central

Cape Town, Western Cape, 7530, South Africa
Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The Catholic University Of Korea St. Vincent's Hospital

Suwon, Kyǒnggi-do, 16247, South Korea
The First Hospital of China Medical University/Dermatology and STD Department

Shenyang, Liaoning, 110001, China
The First Hospital of Wuhan

Wuhan, Hubei, 430022, China
The NeuroMedical Center (XRay)

Baton Rouge, Louisiana, 70810, United States
The Skin Hospital

Darlinghurst, New South Wales, 2010, Australia
The first Affiliated hospital of Wenzhou medical University

Wenzhou, Zhejiang, 325000, China
Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China
Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan
Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan
Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, 71-500, Poland
UMHAT "Prof. dr. Stoyan Kirkovich" AD

Stara Zagora, 6000, Bulgaria
Universitaetsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham Faculty Office Towers (Regulatory

Birmingham, Alabama, 35294, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States
University of North Carolina Medical Center

Chapel Hill, North Carolina, 27516, United States
Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808, United States
Visage Dermatology and Aesthetic Center

Bowie, Maryland, 20716, United States
Wallace Medical Group, Inc

Los Angeles, California, 90056, United States
Whitby Health Centre Dermatology trials

Whitby, Ontario, L1P 0p9, Canada
Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan
Zhejiang Provincial People's Hospital/Dermatology Department

Hangzhou, Zhejiang, 310014, China
Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

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Other studies related to the condition(s) this trial covers.

Could a daily pill help restore skin color in vitiligo?