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

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

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.

Study Overview

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

Detailed Description

Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo

• Study Type: Interventional
• Enrollment (Estimated): 1450
• 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

• Canada
  • Quebec, Canada, G2J 0C4
    • Not yet recruiting
    • ALPHA Recherche Clinique
  • Quebec, Canada, G1V 4T3
    • Recruiting
    • Diex Recherche Quebec Inc.
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Not yet recruiting
      • Wiseman Dermatology Research Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Recruiting
      • SimcoDerm Medical and Surgical Dermatology Center
    • London, Ontario, Canada, N6H 5L5
      • Not yet recruiting
      • Dermeffects
    • Oakville, Ontario, Canada, L6J 7W5
      • Recruiting
      • The Centre for Clinical Trials
    • Toronto, Ontario, Canada, M4W 2N4
      • Not yet recruiting
      • Dermatology on Bloor - Research Toronto
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Not yet recruiting
      • Innovaderm Research Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Recruiting
      • DIEX Recherche Sherbrooke Inc.
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Recruiting
      • Centre de Recherche Saint-Louis
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Not yet recruiting
      • Skinsense Medical Research
• China
  • Fuzhou, China, 350005
    • Not yet recruiting
    • The First Affiliated Hospital Of Fujian Medical University
  • Shanghai, China, 200080
    • Recruiting
    • Shanghai General Hospital
  • Shijiazhuang, China, 050030
    • Recruiting
    • The First Hospital of Hebei Medical University
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital Affiliate of Capital University
    • Beijing, Beijing, China, 100730
      • Not yet recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100730
      • Not yet recruiting
      • Peking Union Medical College Hopital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Not yet recruiting
      • Guangzhou First People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The First Hospital of Hebei Medical University
  • Henan
    • Nanyang, Henan, China, 473000
      • Not yet recruiting
      • Nanyang First People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Not yet recruiting
      • The First Hospital of Wuhan
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Not yet recruiting
      • The First Affiliated Hospital of BaoTou Medical College
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Not yet recruiting
      • Chengdu Second People's Hospital
  • 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
      • Not yet recruiting
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 457-8510
      • Recruiting
      • Japan Community Health Care Organization Chukyo Hospital
    • Nagoya, Aichi, Japan, 457-8510
      • Recruiting
      • Japan Community Healthcare Organization Chukyo Hospital
  • Chiba
    • Sakura, Chiba, Japan, 285-8741
      • Recruiting
      • Toho University Sakura Medical Center
    • Urayasu, Chiba, Japan, 279-0021
      • Recruiting
      • Juntendo University Urayasu Hospital
  • Hyōgo
    • Takarazuka, Hyōgo, Japan, 665-0827
      • Recruiting
      • Takarazuka City Hospital
  • Ibaraki
    • Inashiki, Ibaraki, Japan, 300-0395
      • Recruiting
      • Tokyo Medical University Ibaraki Medical Center
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Recruiting
      • Tokyo Medical University Ibaraki Medical Center
  • Nara
    • Ikoma City, Nara, Japan, 630-0293
      • Recruiting
      • Kindai University Nara Hospital
  • Osaka
    • Habikino, Osaka, Japan, 583-8588
      • Recruiting
      • Osaka Habikino Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Recruiting
      • Hamamatsu University Hospital
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Recruiting
      • Hamamatsu University Hospital
  • Tokyo
    • Bunkyō, Tokyo, Japan, 113-8519
      • Recruiting
      • Tokyo Medical and Dental University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Recruiting
      • Yamaguchi University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Not yet recruiting
      • Total Skin & Beauty Dermatology Center, PC
    • Birmingham, Alabama, United States, 35203
      • Not yet recruiting
      • Total Dermatology
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Center for Dermatology and Plastic Surgery/CCT Research
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Recruiting
      • Dermatology Trial Associates
  • California
    • Fountain Valley, California, United States, 92708
      • Not yet recruiting
      • First OC Dermatology Research Inc
    • Los Angeles, California, United States, 90057
      • Not yet recruiting
      • L.A. Universal Research Center, Inc.
    • Rancho Santa Margarita, California, United States, 92688
      • Not yet recruiting
      • Mission Dermatology Center
    • Rolling Hills Estates, California, United States, 90274
      • Recruiting
      • Peninsula Research Associates
    • San Diego, California, United States, 92122
      • Not yet recruiting
      • University of California San Diego - La Jolla
    • Santa Ana, California, United States, 92705
      • Not yet recruiting
      • Wolverine Clinical Trials
  • Florida
    • Doral, Florida, United States, 33172
      • Recruiting
      • Gamma Diagnostic Lab
    • Fort Lauderdale, Florida, United States, 33308
      • Not yet recruiting
      • FXM Clinical Research - Fort Lauderdale
    • Hialeah, Florida, United States, 33016
      • Not yet recruiting
      • Harmony Medical Research Institute
    • Hialeah, Florida, United States, 33015
      • Recruiting
      • Hear 4 U
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Unlimited Diagnostic Center
    • Miami, Florida, United States, 33165
      • Recruiting
      • New Horizon Research Center
    • Miami, Florida, United States, 33136
      • Recruiting
      • SouthCoast Research Center
    • Miami, Florida, United States, 33173
      • Recruiting
      • Well Pharma Medical Research, Corp.
    • Miami, Florida, United States, 33173
      • Not yet recruiting
      • Miami Dermatology and Laser Research
    • Miami, Florida, United States, 33144
      • Recruiting
      • Bio-Medical Research LLC
    • Miami, Florida, United States, 33179
      • Recruiting
      • Floridian Research Institute Llc
    • Miami, Florida, United States, 33173
      • Not yet recruiting
      • Skin Research of South Florida
    • Miami, Florida, United States, 33155
      • Recruiting
      • Health and Life Research Institute
    • Miami, Florida, United States, 33176
      • Not yet recruiting
      • JD Medical Group
    • Miami, Florida, United States, 33155
      • Recruiting
      • All Hearing Aid, LLC
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • South Miami Medical & Research Group
    • Miami, Florida, United States, 33175
      • Not yet recruiting
      • FXM Clinical Research - Miami
    • Miami, Florida, United States, 33186
      • Recruiting
      • Sanitas Research
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Wellness Clinical Research
    • Miramar, Florida, United States, 33027
      • Not yet recruiting
      • FXM Clinical Research - Miramar
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • GCP Research, Global Clinical professionals
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Not yet recruiting
      • NorthShore University Health System
  • Indiana
    • South Bend, Indiana, United States, 46617
      • Not yet recruiting
      • The South Bend Clinic, LLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Not yet recruiting
      • Dermatology & Advanced Aesthetics
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Recruiting
      • Oakland Hills Dermatology
    • Bay City, Michigan, United States, 48706
      • Not yet recruiting
      • Great Lakes Research Group, Inc.
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Not yet recruiting
      • Medisearch Clinical Trials
  • New Jersey
    • Parsippany, New Jersey, United States, 07054
      • Not yet recruiting
      • Canfield Scientific Inc.
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • OptiSkin Medical
    • New York, New York, United States, 10128
      • Not yet recruiting
      • OptiSkin Medical
    • New York, New York, United States, 10022
      • Not yet recruiting
      • Juva Skin & Laser Center
    • Stony Brook, New York, United States, 11790
      • Not yet recruiting
      • DermResearchCenter of New York, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Not yet recruiting
      • Dermatology Specialists of Charlotte
    • Charlotte, North Carolina, United States, 28277
      • Not yet recruiting
      • Darst Dermatology
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Not yet recruiting
      • Bexley dermatology research
    • Dublin, Ohio, United States, 43016
      • Not yet recruiting
      • Centricity Research Dublin Multispeciality
    • Dublin, Ohio, United States, 43016
      • Not yet recruiting
      • Centricity Research Dublin Multispecialty
  • Oregon
    • Portland, Oregon, United States, 97210
      • Not yet recruiting
      • Oregon Dermatology and Research Center
  • South Carolina
    • Columbia, South Carolina, United States, 29212
      • Recruiting
      • Columbia Dermatology & Aesthetics
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Not yet recruiting
      • International Clinical Research - Tennessee LLC
  • Texas
    • Houston, Texas, United States, 77004
      • Not yet recruiting
      • Center For Clinical Studies
    • Pflugerville, Texas, United States, 78660
      • Recruiting
      • Austin Institute for Clinical Research
    • Pflugerville, Texas, United States, 78660
      • Not yet recruiting
      • Austin Institute for Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Complete Dermatology
    • Sugar Land, Texas, United States, 77478
      • Recruiting
      • Global Imaging
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Fort Bend Hearing
  • Utah
    • Springville, Utah, United States, 84663
      • Not yet recruiting
      • Springville Dermatology - Springville/CCT Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Recruiting
      • The Education & Research Foundation, Inc.
    • Norfolk, Virginia, United States, 23502
      • Not yet recruiting
      • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

   • Meeting reproductive criteria for female participants.

   Disease Characteristics:

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.

   Active vitiligo is defined as:

   Participants will be classified as having active vitiligo based on the presence of at least one active lesion at BL defined as one of the following:

   • 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.

   Stable vitiligo is defined as:

   • Participants will be classified as having stable vitiligo based on an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) will be classified as having stable disease.

   Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.

3. 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.

Exclusion Criteria:

Medical Conditions:

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.

   • Any psychiatric condition including recent or active suicidal ideation or behavior that meets defined criteria.

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.

   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:

   Any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

8. Renal impairment
9. Hepatic dysfunction
10. Other laboratory abnormalities

11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities

    Other Exclusion Criteria:

12. 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.

13. In South Africa only participants are excluded without one of the following:

    • Document evidence form a health professional of having received varicella vaccination (two 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1- Ritlecitinib 100 milligrams (mg); Randomized to Ritlecitinib 100 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.	Drug: Ritlecitinib; 100mg Capsule; Drug: Ritlecitinib; 50mg Capsule
Experimental: Arm 2- Ritlecitinib 50mg; Randomized to Ritlecitinib 50 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.	Drug: Ritlecitinib; 100mg Capsule; Drug: Ritlecitinib; 50mg Capsule
Placebo Comparator: Arm 3- Placebo; Randomized to Placebo QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.	Drug: Placebo; Matching capsule
Experimental: Arm 4- Ritlecitinib 100mg; Non-randomized open-label Ritlecitinib 100mg QD for 52 weeks.	Drug: Ritlecitinib; 100mg Capsule; Drug: Ritlecitinib; 50mg 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)	52 Weeks
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).	52 Weeks
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.	To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo	Baseline through 108 weeks
Incidence of Clinically significant laboratory abnormalities.		Baseline through 108 weeks

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 F-VASI75 at 24 and 36 weeks	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)	To evaluate the change from baseline in DLQI 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 104
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, week 56, week 60, week 64, week 76, week 88 and week 104.
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, week 56, week 60, week 64, week 76, week 88 and week 104.
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, week 56, week 60, week 64, week 76, week 88 and week 104.
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
Proportion of participants with sustained improvement in T-VASI	Defined as maintenance of ≥T-VASI50 from Week 36 to Week 52	Week 36 through week 52
Proportion of participants with sustained improvement in F-VASI	Defined as maintenance of ≥F-VASI75 from Week 36 to 52	Week 36 through week 52
Time to rescue medication use		Baseline through week 104
Percentage change from baseline in F-VASI		Baseline through week 104
Percentage change from baseline in T-VASI		Baseline through week 104
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
Response based on T-VASI100	Proportion of participants achieving T-VASI90 (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 104
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

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): November 8, 2023
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): July 14, 2027

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: B7981080; 2022-502518-98-00 (Other Identifier: EU CTIS)

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