ACTIVE_NOT_RECRUITING

A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

Conditions

Stable Nonsegmental Vitiligo Active Nonsegmental Vitiligo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: * Are 18 years of age or older. * are confirmed to have nonsegmental vitiligo for at least 3 months. * Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: * vitiligo rating, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG, * photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Quick Facts

Study Start:2023-11-08

Study Completion:2027-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06072183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening. 2. Eligible participants must have at both Screening and BL: * A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and * BSA involvement 4% to 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 to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. 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 and T-VASI ≥3; and * Either active or stable nonsegmental vitiligo at Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease. * New/extending lesions(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. 3. Additional inclusion criteria are: * 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.	1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 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 criteria (including but not limited to segmental vitiligo and mixed vitiligo). * Currently have active forms of other hypopigmentation (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, 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, but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or BL 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 infection within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves. 3. General Infection History: * Have 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 tuberculosis. 4. Specific Viral Infection History: * History (single episode) of disseminated HZ or disseminated herpes simplex or recurrent (more than one episode of) localized, dermatomal HZ. * Infected with HBV or HCV: all participants will undergo screening for HBV and HBC 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. Other Medical Conditions: * 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 current, 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). 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. 6. Have received any of the prohibited treatment regimens specified. 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. 8. Renal impairment 9. Hepatic dysfunction 10. Other laboratory abnormalities 11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities

Inclusion Criteria

Exclusion Criteria

1. Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening.
2. Eligible participants must have at both Screening and BL:
* A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
* BSA involvement 4% to 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 to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. 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 and T-VASI ≥3; and
* Either active or stable nonsegmental vitiligo at Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.
* New/extending lesions(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.
3. Additional inclusion criteria are:
* 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.

1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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 criteria (including but not limited to segmental vitiligo and mixed vitiligo).
* Currently have active forms of other hypopigmentation (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, 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, but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or BL 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 infection within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
3. General Infection History:
* Have 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 tuberculosis.
4. Specific Viral Infection History:
* History (single episode) of disseminated HZ or disseminated herpes simplex or recurrent (more than one episode of) localized, dermatomal HZ.
* Infected with HBV or HCV: all participants will undergo screening for HBV and HBC 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. Other Medical Conditions:
* 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 current, 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). 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.
6. Have received any of the prohibited treatment regimens specified.
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.
8. Renal impairment
9. Hepatic dysfunction
10. Other laboratory abnormalities
11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Center for Dermatology and Plastic Surgery/CCT Research

Scottsdale, Arizona, 85260

United States

Dermatology Trial Associates

Bryant, Arkansas, 72022

United States

First OC Dermatology Research Inc

Fountain Valley, California, 92708

United States

Seaside Audiology Vertigo & Ear Specialists

Huntington Beach, California, 92648

United States

Wallace Medical Group, Inc

Los Angeles, California, 90056

United States

Kaiser Permanente

Oakland, California, 94611

United States

Cura Clinical Research - Oxnard

Oxnard, California, 93030

United States

Mission Dermatology Center

Rancho Santa Margarita, California, 92688

United States

Peninsula Research Associates

Rolling Hills Estates, California, 90274

United States

Integrative Skin Science and Research

Sacramento, California, 95815

United States

University of California San Diego - La Jolla

San Diego, California, 92122

United States

Wolverine Clinical Trials

Santa Ana, California, 92706

United States

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436

United States

FXM Clinical Research - Fort Lauderdale

Fort Lauderdale, Florida, 33308

United States

Direct Helpers Research Center

Hialeah, Florida, 33012

United States

Harmony Medical Research Institute

Hialeah, Florida, 33016

United States

Wellness Clinical Research

Miami Lakes, Florida, 33016

United States

University of Miami Dermatology Clinical Trials Unit

Miami, Florida, 33125

United States

Clever Medical Research

Miami, Florida, 33126

United States

JD Medical Group

Miami, Florida, 33133

United States

Miami Dermatology and Laser Research

Miami, Florida, 33133

United States

SouthCoast Research Center

Miami, Florida, 33136

United States

University of Miami

Miami, Florida, 33136

United States

Bio-Medical Research LLC

Miami, Florida, 33144

United States

South Miami Medical & Research Group

Miami, Florida, 33155

United States

New Horizon Research Center

Miami, Florida, 33165

United States

Skin Research of South Florida

Miami, Florida, 33173

United States

Well Pharma Medical Research, Corp.

Miami, Florida, 33173

United States

FXM Clinical Research - Miami

Miami, Florida, 33175

United States

Health and Life Research Institute

Miami, Florida, 33176

United States

University of Miami, Kendall Office

Miami, Florida, 33176

United States

Floridian Research Institute Llc

Miami, Florida, 33179

United States

Sanitas Research

Miami, Florida, 33186

United States

FXM Clinical Research - Miramar

Miramar, Florida, 33027

United States

GCP Research, Global Clinical professionals

Saint Petersburg, Florida, 33705

United States

Advanced Clinical Research Institute

Tampa, Florida, 33607

United States

USF Health

Tampa, Florida, 33612

United States

Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic

Savannah, Georgia, 31419

United States

NorthShore University Health System

Skokie, Illinois, 60077

United States

Indiana University School of Medicine - Indiana CTSI Clinical Research Center

Indianapolis, Indiana, 46202

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

United States

The South Bend Clinic, LLC

South Bend, Indiana, 46617

United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850

United States

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326

United States

CS Mott Center

Detroit, Michigan, 48201

United States

Wayne Health

Detroit, Michigan, 48201

United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202

United States

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506

United States

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516

United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102

United States

OptiSkin Medical

New York, New York, 10128

United States

DermResearchCenter of New York, Inc.

Stony Brook, New York, 11790

United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28211

United States

Darst Dermatology

Charlotte, North Carolina, 28277

United States

Bexley Dermatology Research

Bexley, Ohio, 43209

United States

Centricity Research Dublin Multispecialty

Dublin, Ohio, 43016

United States

Oregon Dermatology and Research Center

Portland, Oregon, 97210

United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Columbia Dermatology & Aesthetics

Columbia, South Carolina, 29212

United States

Palmetto Clinical Trial Services - Greenville

Greenville, South Carolina, 29615

United States

Center for Clinical Studies

Houston, Texas, 77004

United States

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

United States

Complete Dermatology

Sugar Land, Texas, 77479

United States

The Woodlands Dermatology Associates, PA

The Woodlands, Texas, 77380

United States

University of Utah

Murray, Utah, 84107

United States

Springville Dermatology - Springville/CCT Research

Springville, Utah, 84663

United States

The Education & Research Foundation, Inc.

Forest, Virginia, 24551

United States

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2027-07-30

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo