A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo
NCT ID: NCT05583526
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
592 participants
INTERVENTIONAL
2022-12-01
2026-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ritlecitinib 50 mg
Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
Ritlecitinib
50 mg capsule
Placebo
Placebo (placebo arm; approximately 200 participants)
Placebo
Matching capsule
Interventions
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Ritlecitinib
50 mg capsule
Placebo
Matching capsule
Eligibility Criteria
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Inclusion Criteria
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.
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
* 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
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.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham Faculty Office Towers (Regulatory
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Wallace Medical Group, Inc
Los Angeles, California, United States
Audiology
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, United States
Skin Care Research
Hollywood, Florida, United States
Clever Medical Research
Miami, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Olympian Clinical Research
St. Petersburg, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Advanced Medical Research, PC.
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
Baton Rouge, Louisiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
The NeuroMedical Center (XRay)
Baton Rouge, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Prairieville Family Hospital (XRay)
Prairieville, Louisiana, United States
Visage Dermatology and Aesthetic Center
Bowie, Maryland, United States
Lawrence J Green, MD LLC
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Hamzavi Dermatology - Canton
Canton, Michigan, United States
Skin Specialists, PC
Omaha, Nebraska, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Remington Davis Clinical Research
Columbus, Ohio, United States
Remington-Davis, Inc
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
Alpesh D. Desai, DO PLLC - Research
Houston, Texas, United States
Austin Institute for Clinical Research
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
The Skin Hospital
Darlinghurst, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
MC "Asklepiy" OOD
Dupnitsa, , Bulgaria
DCC Aleksandrovska EOOD
Sofia, , Bulgaria
UMHAT "Prof. dr. Stoyan Kirkovich" AD
Stara Zagora, , Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
CaRe Clinic
Red Deer, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
Whitby Health Centre Dermatology trials
Whitby, Ontario, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Fujian Medical University Affiliated First Hospital
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Hospital of Wuhan
Wuhan, Hubei, China
The First Hospital of China Medical University/Dermatology and STD Department
Shenyang, Liaoning, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang, China
Praxis Leitz und Kollegen
Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Istituto Clinico Humanitas, IRCCS
Rozzano, Milano, Italy
Istituti Fisioterapici Ospitalieri (IFO)
Roma, RM, Italy
Policlinico S. Orsola- Malpighi
Bologna, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Sugamo Kobayashi Derma Clinic
Toshima-Ku, Tokyo, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Nippon Medical School Hospital
Tokyo, , Japan
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, , Mexico
Sociedad de Metabolismo Y Corazon Sc
Veracruz, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko, Kuyavian-Pomeranian Voivodeship, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland
Dermedic Jacek Zdybski
Ostrowiec Witokrzyski, Świętokrzyskie Voivodeship, Poland
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
Clinresco Centres
Kempton Park, Gauteng, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa
Task Central
Cape Town, Western Cape, South Africa
Dongguk University Ilsan Hospital
Goyang-si, Kyǒnggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
AUDIKA
Córdoba, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri, , Turkey (Türkiye)
Celal Bayar Universitesi Hafta Sultan Hastanesi
Manisa, , Turkey (Türkiye)
Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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Tranquillo
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501668-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7981040
Identifier Type: -
Identifier Source: org_study_id
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