A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
A legfontosabb adatok
- Ki végzi
- Pfizer
- Hol
- Albuquerque, Ann Arbor, Baton Rouge, Boynton Beach, Brooklyn, Chapel Hill, Charleston, Cleveland, Columbus, Dallas, Encinitas, Hollywood, Houston, Huntington Beach, Indianapolis, Los Angeles, Rockville, Tampa és Wilmington (Egyesült Államok)Mind a 22 helyszín megnézéseMég 13 másik országban, 53 helyszínen
- Azonosító
- Állapot
- Fut, nem toboroz
- Fázis
- 3. fázis
- Résztvevők
- 394 fő vett részt
- Kezdés
- 2024. jan. 19.
- Várható befejezés
- 2027. márc. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Ritlecitinib
- Ritlecitinib 100 mg
- Placebo
- A regiszteradat frissítve
- 2026. szeptember 28.
Ki vehet részt
- Életkor
- 12 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 5 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
- Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
Helyszínek itt: Egyesült Államok
Még 13 másik országban, 53 helyszínen
- University of New Mexico Health Sciences CenterAlbuquerque, Egyesült ÁllamokNo longer taking part
- University of MichiganAnn Arbor, Egyesült ÁllamokNo longer taking part
- DelRicht ResearchBaton Rouge, Egyesült ÁllamokNo longer taking part
- Encore Medical Research of Boynton BeachBoynton Beach, Egyesült ÁllamokNo longer taking part
- SUNY Downstate Health Sciences UniversityBrooklyn, Egyesült ÁllamokNo longer taking part
- Clinical & Translational Research Center (CTRC)Chapel Hill, Egyesült ÁllamokNo longer taking part
- University of North Carolina Medical CenterChapel Hill, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, Egyesült ÁllamokNo longer taking part
- Remington Davis, Inc.Columbus, Egyesült ÁllamokNo longer taking part
- Modern Research Associates PllcDallas, Egyesült ÁllamokNo longer taking part
- California Dermatology & Clinical Research InstituteEncinitas, Egyesült ÁllamokNo longer taking part
- Skin Care ResearchHollywood, Egyesült ÁllamokNo longer taking part
- Alpesh D. Desai, DO PLLCHouston, Egyesült ÁllamokNo longer taking part
- Austin Institute for Clinical ResearchHouston, Egyesült ÁllamokNo longer taking part
- Marvel Clinical ResearchHuntington Beach, Egyesült ÁllamokNo longer taking part
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, Egyesült ÁllamokNo longer taking part
- Wallace Medical Group, IncLos Angeles, Egyesült ÁllamokNo longer taking part
- Lawrence J. Green, MD, LLCRockville, Egyesült ÁllamokNo longer taking part
- ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Accellacare - WilmingtonWilmington, Egyesült ÁllamokNo longer taking part
- Wilmington Health, PLLCWilmington, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).
A teljes eredeti leírásKevesebb
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. On study visit days, 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.
A vizsgálat 2 csoportja
- Arm 1A vizsgált kezelés
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
Kezelés: Ritlecitinib, Ritlecitinib 100 mg és Placebo
- Arm 2A vizsgált kezelés
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
Kezelés: Ritlecitinib, Ritlecitinib 100 mg és Placebo
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
- Publikációk
- A regiszteradat frissítve
- 2026. szeptember 28.