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

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

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

Study Overview

• Status: Recruiting
• Conditions: Stable Nonsegmental Vitiligo; Active Nonsegmental Vitiligo
• Intervention / Treatment: Drug: Ritlecitinib; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • The Skin Hospital
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • Recruiting
      • North Eastern Health Specialists
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Recruiting
      • Skin Health Institute Inc.
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Sinclair Dermatology
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Recruiting
    • MC "Asklepiy" OOD
  • Sofia, Bulgaria, 1431
    • Recruiting
    • Dcc Aleksandrovska Eood
  • Stara Zagora, Bulgaria, 6000
    • Recruiting
    • UMHAT "Prof. dr. Stoyan Kirkovich" AD
• Canada
  • Quebec, Canada, G1W 4R4
    • Recruiting
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1V 4X7
    • Recruiting
    • Centre de Recherche Dermatologique Du Quebec Metropolitain
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Recruiting
      • Dermatology Research Institute
    • Red Deer, Alberta, Canada, T4P 1K4
      • Recruiting
      • Care Clinic
  • Ontario
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Recruiting
      • Skin Health
    • Markham, Ontario, Canada, L3P 1X3
      • Recruiting
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Recruiting
      • DermEdge Research
    • Oshawa, Ontario, Canada, L1H 1B9
      • Recruiting
      • Oshawa Clinic Dermatology Trials
    • Toronto, Ontario, Canada, M2N3A6
      • Recruiting
      • North York Research Inc
• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Fujian Medical University Affiliated First Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Recruiting
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • The First Hospital of Wuhan
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University/Dermatology and STD Department
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital Fudan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
  • Yunnan Sheng
    • Kunming, Yunnan Sheng, China, 650032
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital/Dermatology Department
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China, 325000
      • Not yet recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Germany
  • Baden-württemberg
    • Stuttgart, Baden-württemberg, Germany, 70178
      • Recruiting
      • Praxis Leitz und Kollegen
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Recruiting
      • Universitaetsklinikum Erlangen
  • Niedersachsen
    • Bad Bentheim, Niedersachsen, Germany, 48455
      • Recruiting
      • Fachklinik Bad Bentheim
  • Nordrhein-westfalen
    • Münster, Nordrhein-westfalen, Germany, 48149
      • Recruiting
      • Universitatsklinikum Munster
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico S. Orsola- Malpighi
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Not yet recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Recruiting
      • Azienda Ospedaliera Spedali Civili di Brescia
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Not yet recruiting
      • Istituto Clinico Humanitas IRCCS
    • Rozzano, Milano, Italy, 20089
      • Not yet recruiting
      • Istituto Clinico Humanitas IRCSS - UOC di Dermatologia
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas, IRCCS
  • RM
    • Roma, RM, Italy, 00144
      • Not yet recruiting
      • Istituti Fisioterapici Ospitalieri (IFO) - Roma
    • Roma, RM, Italy, 00144
      • Recruiting
      • Istituti Fisioterapici Ospitalieri (IFO)
• Japan
  • Tokyo, Japan, 113-8603
    • Recruiting
    • Nippon Medical School Hospital
  • Tokyo, Japan, 113-8603
    • Not yet recruiting
    • Nippon Medical School Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Recruiting
      • Nagoya City University Hospital
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Osaka
    • Sakai City, Osaka, Japan, 593-8324
      • Recruiting
      • Dermatology and Ophthalmology Kume Clinic
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Recruiting
      • Tokyo Medical University Hospital
    • Toshima-Ku, Tokyo, Japan, 170-0002
      • Recruiting
      • Sugamo Kobayashi Derma Clinic
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-8506
      • Recruiting
      • Yamanashi Prefectural Central Hospital
• Korea, Republic of
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, Korea, Republic of, 10326
      • Recruiting
      • Dongguk University Ilsan Hospital
    • Suwon, Kyǒnggi-do, Korea, Republic of, 16499
      • Recruiting
      • Ajou University Hospital
    • Suwon-si, Kyǒnggi-do, Korea, Republic of, 16247
      • Recruiting
      • The Catholic University Of Korea St. Vincent's Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722
      • Recruiting
      • Severance Hospital, Yonsei University Health System
• Mexico
  • Veracruz, Mexico, 91910
    • Recruiting
    • Arké SMO S.A de C.V
  • Veracruz, Mexico, 91900
    • Recruiting
    • Sociedad de Metabolismo y Corazon S.C.
  • Veracruz, Mexico, 91900
    • Recruiting
    • Sociedad de Metabolismo Y Corazon Sc
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 64460
      • Recruiting
      • Centro de Dermatologia de Monterrey
• Poland
  • Kujawsko-pomorskie
    • Osielsko, Kujawsko-pomorskie, Poland, 86-031
      • Recruiting
      • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-962
      • Recruiting
      • Royalderm Agnieszka Nawrocka
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 71-500
      • Not yet recruiting
      • Twoja Przychodnia Scm
    • Szczecin, Zachodniopomorskie, Poland, 71-500
      • Recruiting
      • Twoja Przychodnia Scm
  • Łódzkie
    • Lodz, Łódzkie, Poland, 90-436
      • Recruiting
      • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
  • Świętokrzyskie
    • Ostrowiec Witokrzyski, Świętokrzyskie, Poland, 27-400
      • Recruiting
      • Dermedic Jacek Zdybski
• South Africa
  • Eastern CAPE
    • Port Elizabeth, Eastern CAPE, South Africa, 6001
      • Recruiting
      • Phoenix Pharma
  • Gauteng
    • Kempton Park, Gauteng, South Africa, 1619
      • Recruiting
      • Clinresco Centres
    • Pretoria, Gauteng, South Africa, 0184
      • Not yet recruiting
      • Botho ke Bontle Health Services
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7530
      • Recruiting
      • TASK Central
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic de Barcelona
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28046
    • Not yet recruiting
    • Hospital Universitario La Paz
  • Andalucía
    • Cordoba, Andalucía, Spain, 14004
      • Recruiting
      • Hospital Universitario Reina Sofia
  • Canarias
    • Las Palmas de Gran Canaria, Canarias, Spain, 35010
      • Recruiting
      • Hospital Universitario de Gran Canaria Doctor Negrin
• Turkey
  • Istanbul, Turkey, 34890
    • Recruiting
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey, 34098
    • Recruiting
    • Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi
  • Kayseri, Turkey, 38039
    • Recruiting
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri
  • Manisa, Turkey, 45030
    • Recruiting
    • Celal Bayar Universitesi Hafta Sultan Hastanesi
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guy's & St Thomas' NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham Faculty Office Towers (Regulatory
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • California Dermatology & Clinical Research Institute
    • Fremont, California, United States, 94538
      • Not yet recruiting
      • Center for Dermatology Clinical Research, Inc.
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Marvel Clinical Research
    • Los Angeles, California, United States, 90056
      • Recruiting
      • Wallace Medical Group, Inc
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Audiology
    • Washington, District of Columbia, United States, 20037
      • Terminated
      • Center for Dermatology and Dermatologic Surgery
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Recruiting
      • Encore Medical Research of Boynton Beach
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Skin Care Research
    • Lutz, Florida, United States, 33548
      • Recruiting
      • JC Audiology
    • Miami, Florida, United States, 33125
      • Not yet recruiting
      • Millennium Clinical Research
    • Miami, Florida, United States, 33126
      • Recruiting
      • Clever Medical Research
    • North Miami Beach, Florida, United States, 33162
      • Recruiting
      • Tory Sullivan, Md Pa
    • North Miami Beach, Florida, United States, 33162
      • Not yet recruiting
      • Tory Sullivan, Md Pa
    • North Miami Beach, Florida, United States, 33162
      • Recruiting
      • Ziaderm Research, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Terminated
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33618
      • Recruiting
      • Tower Imaging, LLC dba TGH Imaging powered by Tower
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Marietta Dermatology Clinical Research, Inc
    • Sandy Springs, Georgia, United States, 30328
      • Terminated
      • Advanced Medical Research, PC.
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Dawes Fretzin Clinical Research Group, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Delricht Research
    • Baton Rouge, Louisiana, United States, 70810
      • Recruiting
      • The NeuroMedical Center (XRay)
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Delricht Research
    • Prairieville, Louisiana, United States, 70769
      • Recruiting
      • Prairieville Family Hospital (XRay)
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Not yet recruiting
      • Callender Center for Clinical Research
    • Largo, Maryland, United States, 20774
      • Recruiting
      • Visage Dermatology and Aesthetic Center
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Lawrence J Green, MD LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
    • Brighton, Massachusetts, United States, 02135
      • Recruiting
      • MetroBoston Clinical Partners, LLC
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Chan Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Canton, Michigan, United States, 48187
      • Recruiting
      • Hamzavi Dermatology - Canton
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • University of New Mexico Health Sciences Center
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • SUNY Downstate Health Sciences University
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Recruiting
      • University of North Carolina Medical Center
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Clinical & Translational Research Center (CTRC)
    • Wilmington, North Carolina, United States, 28411
      • Recruiting
      • Accellacare - Wilmington
    • Wilmington, North Carolina, United States, 28411
      • Recruiting
      • Accellacare
    • Wilmington, North Carolina, United States, 28411
      • Recruiting
      • PMG Research of Wilmington, LLC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43215
      • Recruiting
      • Remington Davis Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Modern Research Associates, PLLC
    • Houston, Texas, United States, 77056
      • Recruiting
      • Austin Institute for Clinical Research
    • Houston, Texas, United States, 77008
      • Not yet recruiting
      • Alpesh D. Desai, DO PLLC
    • Houston, Texas, United States, 77008
      • Recruiting
      • Alpesh D. Desai, DO PLLC - Research
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Recruiting
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 ideation or 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) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ritlecitinib 50 mg; Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)	Drug: Ritlecitinib; 50 mg capsule
Placebo Comparator: Placebo; Placebo (placebo arm; approximately 200 participants)	Drug: Placebo; Matching capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
US only Co-Primary Endpoints: Response based on Total body Vitiligo Area Scoring Index 75 (T-VASI75) at Week 52 and T-VASI50 at Week 52	Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)	Week 52
Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52	Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).	Week 52
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities	safety and tolerability of ritlecitinib in participants with nonsegmental vitaligo	Baseline through Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
US-Only: Response based on F-VASI75 at 24, 26 and 52 weeks	Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline.	24, 36 and 52 Weeks
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).	24 and 36 weeks
Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)	To assess the effect of ritlecitinib compared to placebo on the PGIS-F at Week 36 and 52	Week 36 and week 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	To assess the effect of ritlecitinib compared to placebo on the PGIS-V at Week 36 and 52	Week 36 and week 52
Global (Other Than US): Response based on T-VASI50 at Week 52	Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).	Week 52
Patient Global Impression of Change-Face (PGIC-F)	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Weeks 36 and 52.	Week 36 and week 52
Patient Global Impression of Change- Overall vitiligo(PGIC-V)	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Weeks 36 and 52.	Week 36 and week 52
Global (Other than US): Response based on T-VASI75	Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)	Baseline through week 52
Response based on T-VASI90	Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)	Baseline through week 52
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	Week 52
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)	Week 52
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)	Week 52
US-Only: Patient Global Impression of Severity-Face (PGIS-F)	To assess the effect of ritlecitinib compared to placebo on the PGIS-F at 52	Week 52
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52	Week 52
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).	Week 24 and week 36
Global (Other than US): Response based on PGIS-V	Proportion of participants achieving PGIC-V response	36 and 52 weeks
Global (Other than US): Response based on F-VASI75	Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)	24 and 36 weeks
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	Week 52
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 and 100mg compared to placebo	Baseline through week 52
Response based on T-VASI50	Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 48.
Response based on F-VASI75	Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 48.
US only: Response based on T-VASI75	Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 24, week 36, week 48.
All Countries: Time to rescue medication		Baseline through week 52
Percentage change from baseline in F-VASI		Baseline through week 52
Percentage change from baseline in T-VASI		Baseline through week 52
Response based on T-VASI100	Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)	Baseline through week 52
Response based on F-VASI50	Proportion of participants achieving F-VASI50 (defined as at least 50% improvement in F-VASI from Baseline).	Baseline through week 52
Response based on F-VASI90	Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).	Baseline through week 52
Response based on F-VASI100	Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).	Baseline through week 52

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): June 27, 2025
• Study Completion (Estimated): June 27, 2025

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Non-segmental vitiligo (both active and stable vitiligo)
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: B7981040; Tranquillo (Other Identifier: Alias Study Number); 2022-501668-16-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No