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Stable Nonsegmental VitiligoPhase 3TranquilloNCT05583526

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

A Phase 3 study testing Ritlecitinib in people with Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo, run by Pfizer at 115 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 years and older
What is being tested?
Ritlecitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
607 participants
Where
115 sitesin 15 countries
Study dates
1 Dec 2022to 5 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • 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.
  • Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.

Who cannot join

  • 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:
  • 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).
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  • 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.
  • 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.
  • 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:
  • Have received any of the prohibited treatment regimens specified.
  • Prior/Concurrent Clinical Study Experience:
  • 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:
  • 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
  • Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities
  • Other Exclusion Criteria:
  • 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.
  • 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.

Trial locations and contacts

115 sites in 15 countries.

115 sites in 15 countries

United States46 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

    Baton Rouge, Louisiana, 70808

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • The NeuroMedical Center (XRay)

    Baton Rouge, Louisiana, 70810

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham Faculty Office Towers (Regulatory

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Visage Dermatology and Aesthetic Center

    Bowie, Maryland, 20716

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida, 33436

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • Hamzavi Dermatology - Canton

    Canton, Michigan, 48187

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27516

  • Clinical & Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • Modern Research Associates, PLLC

    Dallas, Texas, 75231

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Skin Care Research

    Hollywood, Florida, 33021

  • Alpesh D. Desai, DO PLLC - Research

    Houston, Texas, 77008

  • Austin Institute for Clinical Research

    Houston, Texas, 77056

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Wallace Medical Group, Inc

    Los Angeles, California, 90056

  • Clever Medical Research

    Miami, Florida, 33126

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162

  • Skin Specialists, PC

    Omaha, Nebraska, 68144

  • Prairieville Family Hospital (XRay)

    Prairieville, Louisiana, 70769

  • Lawrence J Green, MD LLC

    Rockville, Maryland, 20850

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Advanced Medical Research, PC.

    Sandy Springs, Georgia, 30328

  • Olympian Clinical Research

    St. Petersburg, Florida, 33709

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Audiology

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Center for Dermatology and Dermatologic Surgery

    Washington D.C., District of Columbia, 20037

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28411

  • Accellacare

    Wilmington, North Carolina, 28411

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28411

Other trials in United States

China11 sites

  • Fujian Medical University Affiliated First Hospital

    Fuzhou, Fujian, 350005

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Zhejiang Provincial People's Hospital/Dermatology Department

    Hangzhou, Zhejiang, 310014

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

    Hangzhou, Zhejiang, 310016

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The First Hospital of China Medical University/Dermatology and STD Department

    Shenyang, Liaoning, 110001

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The first Affiliated hospital of Wenzhou medical University

    Wenzhou, Zhejiang, 325000

  • The First Hospital of Wuhan

    Wuhan, Hubei, 430022

Other trials in China

Canada8 sites

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Québec, G1V 4X7

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4

  • North York Research Inc

    Toronto, Ontario, M2N3A6

  • Whitby Health Centre Dermatology trials

    Whitby, Ontario, L1P 0p9

Other trials in Canada

Japan7 sites

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Sugamo Kobayashi Derma Clinic

    Toshima-Ku, Tokyo, 170-0002

Other trials in Japan

Australia5 sites

  • North Eastern Health Specialists

    Campbelltown, South Australia, 5074

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053

  • The Skin Hospital

    Darlinghurst, New South Wales, 2010

  • Dr Rodney Sinclair Pty Ltd

    East Melbourne, Victoria, 3002

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

Mexico5 sites

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Mexico City, 06720

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo León, 64460

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900

  • Sociedad de Metabolismo Y Corazon Sc

    Veracruz, 91900

  • Arké SMO S.A de C.V

    Veracruz, 91910

Other trials in Mexico

Poland5 sites

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódź Voivodeship, 90-436

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • Dermedic Jacek Zdybski

    Ostrowiec Witokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship, 71-500

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • AUDIKA

    Córdoba, 14001

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Canary Islands, 35010

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

Other trials in Spain

Germany4 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Praxis Leitz und Kollegen

    Stuttgart, Baden-Wurttemberg, 70178

Other trials in Germany

South Africa4 sites

  • Task Central

    Cape Town, Western Cape, 7530

  • Clinresco Centres

    Kempton Park, Gauteng, 1619

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape, 6001

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng, 0184

Other trials in South Africa

South Korea4 sites

  • Dongguk University Ilsan Hospital

    Goyang-si, Kyǒnggi-do, 10326

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon, Kyǒnggi-do, 16247

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri

    Kayseri, 38039

  • Celal Bayar Universitesi Hafta Sultan Hastanesi

    Manisa, 45030

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • MC "Asklepiy" OOD

    Dupnitsa, 2600

  • DCC Aleksandrovska EOOD

    Sofia, 1431

  • UMHAT "Prof. dr. Stoyan Kirkovich" AD

    Stara Zagora, 6000

Other trials in Bulgaria

Italy3 sites

  • Policlinico S. Orsola- Malpighi

    Bologna, 40138

  • Istituti Fisioterapici Ospitalieri (IFO)

    Roma, RM, 00144

  • Istituto Clinico Humanitas, IRCCS

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom1 site

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

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

Read the detailed description

Study B7981040 is a Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with nonsegmental vitiligo (both active and stable vitiligo).

Being tested
Ritlecitinib, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RitlecitinibDrug

    50 mg capsule

  • PlaceboDrug

    Matching capsule

Study groups in NCT05583526
Study groupRoleWhat they receive
Ritlecitinib 50 mgExperimentalRitlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
Receives: Drug: Ritlecitinib
PlaceboPlacebo comparatorPlacebo (placebo arm; approximately 200 participants)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Week 52

  2. 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)

    Measured: Week 52

  3. 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

    Measured: Baseline through Week 52

Secondary outcomes (35)

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

    Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline

    Measured: Weeks 24 and 36

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

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

    Measured: Weeks 24 and 36

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

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

    Measured: Week 52

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

    Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Weeks 24, 36, and 52

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

    Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Weeks 24, 36, and 52

  6. US-Only: Patient Global Impression of Severity-Face (PGIS-F)

    Proportion of responders based on PGIS-F at 52 weeks

    Measured: Week 52

  7. US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)

    Proportion of responders based on PGIS-V at 52 weeks

    Measured: Week 52

  8. Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks

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

    Measured: Weeks 24 and 36

  9. Global (Other Than US): Response based on T-VASI50 at 24, 36, and 52 weeks

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

    Measured: Weeks 24, 36, and 52

  10. Global (Other than US): Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks

    Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Weeks 24, 36, and 52

  11. Global (Other than US): Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks

    Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Weeks 24, 36, and 52

  12. Global (Other than US): Patient Global Impression of Severity-Face (PGIS-F)

    Proportion of responders based on PGIS-F at 24, 36, and 52 weeks

    Measured: Weeks 24, 36, and 52

  13. Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)

    Proportion of responders based on PGIS-V at 24, 36, and 52 weeks

    Measured: Weeks 24, 36, and 52

  14. All Countries: Proportion of participants achieving disease stabilization

    The difference in the proportion of participants with stable disease at all timepoints in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo

    Measured: Baseline through week 52

  15. Response based on T-VASI50

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

    Measured: Baseline through week 4, week 8, week 12, week 48

  16. Response based on F-VASI75

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

    Measured: Baseline through week 4, week 8, week 12, week 48

  17. Response based on T-VASI75

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

    Measured: Baseline through week 4, week 8, week 12, week 24, week 36, week 48

  18. Proportion of participants with sustained improvement in T-VASI

    Defined as maintenance of ≥T-VASI50 from Week 36 to Week 52

    Measured: Week 36 through week 52

  19. Proportion of participants with sustained improvement in F-VASI

    Defined as maintenance of ≥F-VASI75 from Week 36 to 52

    Measured: Week 36 through week 52

  20. All Countries: Time to rescue medication

    Comparing time to rescue medication curves and difference in probabilities of using rescue medication

    Measured: Baseline through week 52

  21. Percentage change from baseline in F-VASI

    Median % CFB in F-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Baseline through week 52

  22. Percentage change from baseline in T-VASI

    Median % CFB in T-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo

    Measured: Baseline through week 52

  23. Response based on T-VASI90

    Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)

    Measured: Baseline through week 52

  24. Response based on T-VASI100

    Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)

    Measured: Baseline through week 52

  25. Response based on F-VASI50

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

    Measured: Baseline through week 52

  26. Response based on F-VASI90

    Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).

    Measured: Baseline through week 52

  27. Response based on F-VASI100

    Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).

    Measured: Baseline through week 52

  28. Patient Global Impression of Severity-Face (PGIS-F)

    Proportion of responders based on PGIS-F at 24 and 26 weeks

    Measured: Weeks 24 and 36

  29. Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)

    Proportion of responders based on PGIS-V at 24 and 36 weeks

    Measured: Weeks 24 and 36

  30. Patient Global Impression of Change-Face (PGIC-F)

    To assess the effect of ritlecitinib compared to placebo on the PGIC-F at 24, 36, and 52 weeks

    Measured: Weeks 24, 36, and 52

  31. Patient Global Impression of Change- Overall Vitiligo (PGIC-V)

    To assess the effect of ritlecitinib compared to placebo on the PGIC-V at 24, 36, and 52 weeks

    Measured: Weeks 24, 36, and 52

  32. Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)

    To evaluate the change from baseline in DLQI or CDLQI at week 52

    Measured: Week 52

  33. Change from baseline in the Hospital Anxiety and Depression Scale (HADS)

    To assess the effect of ritlecitinib compared to placebo on depression and anxiety subscales of the HADS at week 52

    Measured: Week 52

  34. The proportion of patients achieving absence of depression on HADS depression subscale

    Response based on a 'normal' subscale score indicative of an absence of depression (in participants with baseline HADS subscale scores indicative of depression)

    Measured: Week 52

  35. The proportion of patients achieving absence of anxiety on HADS anxiety subscale

    Response based on a 'normal' subscale score indicative of an absence of anxiety (in participants with baseline HADS subscale scores indicative of anxiety)

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start1 Dec 2022
  3. Primary completion5 Feb 2026
  4. Study completion5 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, parallel-group, vehicle controlled.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
607 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583526
Sponsor's protocol ID
B7981040
Other IDs
Tranquillo, 2022-501668-16-00
Acronym
Tranquillo
Status last verified
Feb 2026
First submitted
6 Oct 2022
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Lukic T, Ghosh P, Napatalung L, Wang C, Kurosky SK, Hamzavi I, Sinclair R, Xiang L, Steil K, Rosmarin D, Parsad D, Ezzedine K, Adiri R. Description of the Tranquillo Phase 3 Clinical Trial Designs/Study Protocols to Assess Ritlecitinib in Adults and Adolescents with Nonsegmental Vitiligo. Dermatol Ther (Heidelb). 2026 Jul;16(7):3709-3727. doi: 10.1007/s13555-026-01724-y. Epub 2026 May 22.

    PubMed 42171987

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ritlecitinib in people with Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo, run by Pfizer at 115 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, China, Canada, Japan, Australia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05583526, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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