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

• ClinicalTrials.gov Identifier: NCT05583526
• Recruitment Status: Recruiting
• First Posted: October 17, 2022
• Last Update Posted: February 5, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Stable Nonsegmental Vitiligo; Active Nonsegmental Vitiligo	Drug: Ritlecitinib; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind, parallel-group, vehicle controlled.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 NONSEGMENTAL VITILIGO
• Actual Study Start Date: December 1, 2022
• Estimated Primary Completion Date: June 27, 2025
• Estimated Study Completion Date: June 27, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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)
2. Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 [ Time Frame: Week 52 ]
   Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
3. Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities [ Time Frame: Baseline through Week 52 ]
   safety and tolerability of ritlecitinib in participants with nonsegmental vitaligo

Secondary Outcome Measures :

1. US-Only: Response based on F-VASI75 at 24, 26 and 52 weeks [ Time Frame: 24, 36 and 52 Weeks ]
   Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline.
2. US-Only: Response based on T-VASI50 at 24 and 36 weeks [ Time Frame: 24 and 36 weeks ]
   Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
3. Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F) [ Time Frame: Week 36 and week 52 ]
   To assess the effect of ritlecitinib compared to placebo on the PGIS-F at Week 36 and 52
4. Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) [ Time Frame: Week 36 and week 52 ]
   To assess the effect of ritlecitinib compared to placebo on the PGIS-V at Week 36 and 52
5. Global (Other Than US): Response based on T-VASI50 at Week 52 [ Time Frame: Week 52 ]
   Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
6. Patient Global Impression of Change-Face (PGIC-F) [ Time Frame: Week 36 and week 52 ]
   To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Weeks 36 and 52.
7. Patient Global Impression of Change- Overall vitiligo(PGIC-V) [ Time Frame: Week 36 and week 52 ]
   To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Weeks 36 and 52.
8. Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks [ Time Frame: Week 24 and week 36 ]
   Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
9. Global (Other than US): Response based on PGIS-V [ Time Frame: 36 and 52 weeks ]
   Proportion of participants achieving PGIC-V response
10. Global (Other than US): Response based on F-VASI75 [ Time Frame: 24 and 36 weeks ]
    Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
11. Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI) [ Time Frame: Week 52 ]
    To evaluate the change from baseline in DLQI or CDLQI at week 52
12. Proportion of participants achieving disease stabilization [ Time Frame: Baseline through week 52 ]
    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
13. Response based on T-VASI50 [ Time Frame: Baseline through week 4, week 8, week 12, week 48. ]
    Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
14. Response based on F-VASI75 [ Time Frame: Baseline through week 4, week 8, week 12, week 48. ]
    Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
15. US only: Response based on T-VASI75 [ Time Frame: Baseline through week 4, week 8, week 12, week 24, week 36, week 48. ]
    Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
16. Global (Other than US): Response based on T-VASI75 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
17. All Countries: Time to rescue medication [ Time Frame: Baseline through week 52 ]
18. Percentage change from baseline in F-VASI [ Time Frame: Baseline through week 52 ]
19. Percentage change from baseline in T-VASI [ Time Frame: Baseline through week 52 ]
20. Response based on T-VASI90 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)
21. Response based on T-VASI100 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)
22. Response based on F-VASI50 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving F-VASI50 (defined as at least 50% improvement in F-VASI from Baseline).
23. Response based on F-VASI90 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).
24. Response based on F-VASI100 [ Time Frame: Baseline through week 52 ]
    Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).
25. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 52 ]
    To assess the effect of ritlecitinib compared to placebo on depression and anxiety subscales of the HADS at week 52
26. The proportion of patients achieving absence of depression on HADS depression subscale [ Time Frame: Week 52 ]
    Response based on a 'normal' subscale score indicative of an absence of depression (in participants with baseline HADS subscale scores indicative of depression)
27. The proportion of patients achieving absence of anxiety on HADS anxiety subscale [ Time Frame: Week 52 ]
    Response based on a 'normal' subscale score indicative of an absence of anxiety (in participants with baseline HADS subscale scores indicative of anxiety)
28. US-Only: Patient Global Impression of Severity-Face (PGIS-F) [ Time Frame: Week 52 ]
    To assess the effect of ritlecitinib compared to placebo on the PGIS-F at 52
29. US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) [ Time Frame: Week 52 ]
    To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham Faculty Office Towers (Regulatory; Recruiting

Birmingham, Alabama, United States, 35294

United States, California

California Dermatology & Clinical Research Institute; Recruiting

Encinitas, California, United States, 92024

Center For Dermatology Clinical Research, Inc.; Not yet recruiting

Fremont, California, United States, 94538

Marvel Clinical Research; Recruiting

Huntington Beach, California, United States, 92647

Wallace Medical Group, Inc; Recruiting

Los Angeles, California, United States, 90056

United States, District of Columbia

Audiology; Recruiting

Washington, District of Columbia, United States, 20007

MedStar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Center for Dermatology and Dermatologic Surgery; Terminated

Washington, District of Columbia, United States, 20037

United States, Florida

Encore Medical Research of Boynton Beach; Recruiting

Boynton Beach, Florida, United States, 33436

Skin Care Research; Recruiting

Hollywood, Florida, United States, 33021

JC Audiology; Recruiting

Lutz, Florida, United States, 33548

Millennium Clinical Research; Not yet recruiting

Miami, Florida, United States, 33125

Clever Medical Research; Recruiting

Miami, Florida, United States, 33126

Tory Sullivan, MD PA; Not yet recruiting

North Miami Beach, Florida, United States, 33162

Tory Sullivan, Md Pa; Recruiting

North Miami Beach, Florida, United States, 33162

Ziaderm Research, LLC; Recruiting

North Miami Beach, Florida, United States, 33162

Olympian Clinical Research; Terminated

Saint Petersburg, Florida, United States, 33709

ForCare Clinical Research; Recruiting

Tampa, Florida, United States, 33613

Tower Imaging, LLC dba TGH Imaging powered by Tower; Recruiting

Tampa, Florida, United States, 33618

United States, Georgia

Marietta Dermatology Clinical Research, Inc; Recruiting

Marietta, Georgia, United States, 30060

Advanced Medical Research, PC.; Terminated

Sandy Springs, Georgia, United States, 30328

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC; Recruiting

Indianapolis, Indiana, United States, 46250

United States, Louisiana

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge; Recruiting

Baton Rouge, Louisiana, United States, 70808

DelRicht Research; Recruiting

Baton Rouge, Louisiana, United States, 70809

The NeuroMedical Center (XRay); Recruiting

Baton Rouge, Louisiana, United States, 70810

DelRicht Research; Recruiting

New Orleans, Louisiana, United States, 70115

Prairieville Family Hospital (XRay); Recruiting

Prairieville, Louisiana, United States, 70769

United States, Maryland

Callender Center for Clinical Research; Not yet recruiting

Glenn Dale, Maryland, United States, 20769

Visage Dermatology and Aesthetic Center; Recruiting

Largo, Maryland, United States, 20774

Lawrence J Green, MD LLC; Recruiting

Rockville, Maryland, United States, 20850

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

MetroBoston Clinical Partners, LLC; Recruiting

Brighton, Massachusetts, United States, 02135

University of Massachusetts Chan Medical School; Recruiting

Worcester, Massachusetts, United States, 01655

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Hamzavi Dermatology - Canton; Recruiting

Canton, Michigan, United States, 48187

United States, Nebraska

Skin Specialists, PC; Recruiting

Omaha, Nebraska, United States, 68144

United States, New Mexico

University of New Mexico Health Sciences Center; Recruiting

Albuquerque, New Mexico, United States, 87102

United States, New York

SUNY Downstate Health Sciences University; Recruiting

Brooklyn, New York, United States, 11203

Icahn School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

United States, North Carolina

University of North Carolina Medical Center; Recruiting

Chapel Hill, North Carolina, United States, 27516

Clinical & Translational Research Center (CTRC); Recruiting

Chapel Hill, North Carolina, United States, 27599

Accellacare - Wilmington; Recruiting

Wilmington, North Carolina, United States, 28411

Accellacare; Recruiting

Wilmington, North Carolina, United States, 28411

PMG Research of Wilmington, LLC; Recruiting

Wilmington, North Carolina, United States, 28411

United States, Ohio

University Hospitals Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Remington Davis Clinical Research; Recruiting

Columbus, Ohio, United States, 43215

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

United States, Texas

Bellaire Dermatology Associates; Recruiting

Bellaire, Texas, United States, 77401

Modern Research Associates, PLLC; Recruiting

Dallas, Texas, United States, 75231

Alpesh D. Desai, DO PLLC - Research; Recruiting

Houston, Texas, United States, 77008

Alpesh D. Desai, DO PLLC; Not yet recruiting

Houston, Texas, United States, 77008

Austin Institute for Clinical Research; Recruiting

Houston, Texas, United States, 77056

Progressive Clinical Research; Recruiting

San Antonio, Texas, United States, 78213

Texas Dermatology and Laser Specialists; Recruiting

San Antonio, Texas, United States, 78218

Dermatology Clinical Research Center of San Antonio; Recruiting

San Antonio, Texas, United States, 78229

Australia, New South Wales

The Skin Hospital; Recruiting

Darlinghurst, New South Wales, Australia, 2010

Australia, South Australia

North Eastern Health Specialists; Recruiting

Campbelltown, South Australia, Australia, 5074

Australia, Victoria

Skin Health Institute Inc.; Recruiting

Carlton, Victoria, Australia, 3053

Sinclair Dermatology; Recruiting

East Melbourne, Victoria, Australia, 3002

The Alfred Hospital; Recruiting

Melbourne, Victoria, Australia, 3004

Bulgaria

MC "Asklepiy" OOD; Recruiting

Dupnitsa, Bulgaria, 2600

DCC Aleksandrovska EOOD; Recruiting

Sofia, Bulgaria, 1431

UMHAT "Prof. dr. Stoyan Kirkovich" AD; Recruiting

Stara Zagora, Bulgaria, 6000

Canada, Alberta

Dermatology Research Institute; Recruiting

Calgary, Alberta, Canada, T2J 7E1

CARe Clinic; Recruiting

Red Deer, Alberta, Canada, T4P 1K4

Canada, Ontario

SKiN Health; Recruiting

Cobourg, Ontario, Canada, K9A 0Z4

Lynderm Research Inc.; Recruiting

Markham, Ontario, Canada, L3P 1X3

DermEdge Research; Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Oshawa Clinic Dermatology Trials; Recruiting

Oshawa, Ontario, Canada, L1H 1B9

North York Research Inc; Recruiting

Toronto, Ontario, Canada, M2N3A6

Canada

Centre de Recherche Dermatologique du Quebec metropolitain; Recruiting

Quebec, Canada, G1V 4X7

Centre de Recherche Saint-Louis; Recruiting

Quebec, Canada, G1W 4R4

China, Fujian

Fujian Medical University Affiliated First Hospital; Recruiting

Fuzhou, Fujian, China, 350005

China, Guangdong

Dermatology Hospital of Southern Medical University; Recruiting

Guangzhou, Guangdong, China, 510091

Guangzhou First People's Hospital; Recruiting

Guangzhou, Guangdong, China, 510180

China, Hubei

The First Hospital of Wuhan; Recruiting

Wuhan, Hubei, China, 430022

China, Liaoning

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

Shenyang, Liaoning, China, 110001

China, Shanghai

Huashan Hospital Fudan University; Recruiting

Shanghai, Shanghai, China, 200040

China, Tianjin

Tianjin Medical University General Hospital; Recruiting

Tianjin, Tianjin, China, 300052

China, Yunnan Sheng

First Affiliated Hospital of Kunming Medical University; Recruiting

Kunming, Yunnan Sheng, China, 650032

China, Zhejiang

Zhejiang Provincial People's Hospital/Dermatology Department; Recruiting

Hangzhou, Zhejiang, China, 310014

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University; Recruiting

Hangzhou, Zhejiang, China, 310016

The first Affiliated hospital of Wenzhou medical University; Not yet recruiting

Wenzhou, Zhejiang, China, 325000

The first Affiliated hospital of Wenzhou medical University; Recruiting

Wenzhou, Zhejiang, China, 325000

Germany

Praxis Leitz und Kollegen; Recruiting

Stuttgart, Baden-württemberg, Germany, 70178

Universitaetsklinikum Erlangen; Recruiting

Erlangen, Bayern, Germany, 91054

Fachklinik Bad Bentheim; Recruiting

Bad Bentheim, Niedersachsen, Germany, 48455

Universitätsklinikum Münster; Recruiting

Münster, Nordrhein-westfalen, Germany, 48149

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore; Not yet recruiting

Roma, Lazio, Italy, 00168

Azienda Ospedaliera Spedali Civili di Brescia; Recruiting

Brescia, Lombardia, Italy, 25123

Istituto Clinico Humanitas IRCCS; Not yet recruiting

Rozzano, Milano, Italy, 20089

Istituto Clinico Humanitas IRCSS - UOC di Dermatologia; Not yet recruiting

Rozzano, Milano, Italy, 20089

Istituto Clinico Humanitas, IRCCS; Recruiting

Rozzano, Milano, Italy, 20089

Istituti Fisioterapici Ospitalieri (IFO) - Roma; Not yet recruiting

Roma, RM, Italy, 00144

Istituti Fisioterapici Ospitalieri (IFO); Recruiting

Roma, RM, Italy, 00144

Policlinico S. Orsola- Malpighi; Recruiting

Bologna, Italy, 40138

Azienda Ospedaliera Spedali Civili di Brescia; Recruiting

Brescia, Italy, 25123

Japan

Nagoya City University Hospital; Recruiting

Nagoya, Aichi, Japan, 467-8602

Tohoku University Hospital; Recruiting

Sendai-shi, Miyagi, Japan, 980-8574

Dermatology and Ophthalmology Kume Clinic; Recruiting

Sakai City, Osaka, Japan, 593-8324

Tokyo Medical University Hospital; Recruiting

Shinjuku-ku, Tokyo, Japan, 160-0023

Sugamo Kobayashi Derma Clinic; Recruiting

Toshima-Ku, Tokyo, Japan, 170-0002

Yamanashi Prefectural Central Hospital; Recruiting

Kofu, Yamanashi, Japan, 400-8506

Nippon Medical School Hospital; Not yet recruiting

Tokyo, Japan, 113-8603

Nippon Medical School Hospital; Recruiting

Tokyo, Japan, 113-8603

Korea, Republic of

Dongguk University Ilsan Hospital; Recruiting

Goyang-si, Kyǒnggi-do, Korea, Republic of, 10326

The Catholic University Of Korea St. Vincent's Hospital; Recruiting

Suwon-si, Kyǒnggi-do, Korea, Republic of, 16247

Ajou University Hospital; Recruiting

Suwon, Kyǒnggi-do, Korea, Republic of, 16499

Severance Hospital, Yonsei University Health System; Recruiting

Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722

Mexico

Centro de Dermatologia de Monterrey; Recruiting

Monterrey, Nuevo LEÓN, Mexico, 64460

Sociedad de Metabolismo y Corazon S.C.; Recruiting

Veracruz, Mexico, 91900

Sociedad de Metabolismo Y Corazon Sc; Recruiting

Veracruz, Mexico, 91900

Arké SMO S.A de C.V; Recruiting

Veracruz, Mexico, 91910

Poland

DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.; Recruiting

Osielsko, Kujawsko-pomorskie, Poland, 86-031

Royalderm Agnieszka Nawrocka; Recruiting

Warszawa, Mazowieckie, Poland, 02-962

Twoja Przychodnia SCM; Not yet recruiting

Szczecin, Zachodniopomorskie, Poland, 71-500

Twoja Przychodnia SCM; Recruiting

Szczecin, Zachodniopomorskie, Poland, 71-500

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

Lodz, Łódzkie, Poland, 90-436

Dermedic Jacek Zdybski; Recruiting

Ostrowiec Witokrzyski, Świętokrzyskie, Poland, 27-400

South Africa

Phoenix Pharma; Recruiting

Port Elizabeth, Eastern CAPE, South Africa, 6001

Clinresco Centres; Recruiting

Kempton Park, Gauteng, South Africa, 1619

Botho Ke Bontle Health Services; Not yet recruiting

Pretoria, Gauteng, South Africa, 0184

Task Central; Recruiting

Cape Town, Western CAPE, South Africa, 7530

Spain

Hospital Universitario Reina Sofia; Recruiting

Cordoba, Andalucía, Spain, 14004

Hospital Universitario de Gran Canaria Doctor Negrín; Recruiting

Las Palmas de Gran Canaria, Canarias, Spain, 35010

Hospital Clinic de Barcelona; Recruiting

Barcelona, Spain, 08036

Hospital Universitario Ramón y Cajal; Recruiting

Madrid, Spain, 28034

Hospital Universitario La Paz; Not yet recruiting

Madrid, Spain, 28046

Turkey

Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi; Recruiting

Istanbul, Turkey, 34098

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi; Recruiting

Istanbul, Turkey, 34890

Erciyes Universitesi Tıp Fakultesi Hastaneleri; Recruiting

Kayseri, Turkey, 38039

Celal Bayar Universitesi Hafta Sultan Hastanesi; Recruiting

Manisa, Turkey, 45030

United Kingdom

Guy's & St Thomas' NHS Foundation Trust; Recruiting

London, United Kingdom, SE1 9RT

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05583526
• Other Study ID Numbers: B7981040; Tranquillo ( Other Identifier: Alias Study Number ); 2022-501668-16-00 ( Registry Identifier: CTIS (EU) )
• First Posted: October 17, 2022
• Last Update Posted: February 5, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases