Clinical trial NCT06163326: A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
Official title: A PHASE 3 OPEN-LABEL, MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Vitiligo
Keywords: Stable vitiligo
Active vitiligo
Adults
Adolescents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).

Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.

Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:

* if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
* Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
* Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.

This study is seeking for participants who:

* have non-segmental vitiligo (either active or stable) and
* received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.

All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home.

Participants may receive the study medicine or placebo for up to 52 weeks.

The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.

Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.

Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.


Eligibility criteria: Inclusion Criteria:

* Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to \<18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
* Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
* The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Exclusion Criteria:

* Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
* Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
timeFrame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
measure: Incidence of clinically significant laboratory abnormalities
timeFrame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
Secondary outcomes:
measure: Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to Week 52
measure: Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52
timeFrame: Baseline to week 52
measure: Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
timeFrame: Baseline to week 52
measure: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52
timeFrame: Baseline to week 52
measure: Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
timeFrame: Baseline to week 52
measure: Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
timeFrame: Baseline to week 52
measure: Proportion of participants achieving disease stabilization
timeFrame: Baseline to week 52
measure: Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52
timeFrame: Baseline to week 52
measure: Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52
timeFrame: Baseline to week 52
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc
state: California
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Largo
country: United States
facility: Visage Dermatology and Aesthetic Center
state: Maryland
city: Rockville
country: United States
facility: Lawrence J. Green, MD LLC
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Chapel Hill
country: United States
facility: Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Alpesh D. Desai, DO PLLC
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepiy"
state: Kyustendil
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Aleksandrovska
state: Sofia (stolitsa)
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich"AD
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Dermatology Hospital
state: Guangdong
city: Wuhan
country: China
facility: The First Hospital of Wuhan
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University/Dermatology and STD Department
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Stuttgart
country: Germany
facility: Praxis Leitz und Kollegen
state: Baden-württemberg
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-westfalen
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Sakai-City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Sakai
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital
state: Kyǒnggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo LEÓN
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Osielsko
country: Poland
facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
state: Łódzkie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
state: Świętokrzyskie
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [cataluña]
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: LAS Palmas
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad DE
city: Córdoba
country: Spain
facility: AUDIKA
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri
city: Manisa
country: Turkey
facility: Celal Bayar University Hafsa Sultan Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: