A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
A legfontosabb adatok
- Hol
- Bay City, Bellaire, Beverly, Brighton, Cape Coral, Cumming, Dearborn, East Syracuse, Hollywood, Hoover, Houston, Irvine, Kokomo, Las Vegas, Marietta, Miami, Miami Lakes, Murfreesboro, New York, Plymouth Meeting, Richmond, Saint Joseph, San Antonio, Santa Monica, Sherman Oaks, Spokane, Stonecrest, Stony Brook, Sunnyvale, Tampa, Troy és West Jordan (Egyesült Államok)Mind a 34 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Great Lakes Research Group, Inc.Bay City, Egyesült ÁllamokNo longer taking part
- University of Texas Physicians - Bellaire StationBellaire, Egyesült ÁllamokNo longer taking part
- Allcutis Research LLCBeverly, Egyesült ÁllamokNo longer taking part
- Metro Boston Clinical PartnersBrighton, Egyesült ÁllamokNo longer taking part
- Renaissance ResearchCape Coral, Egyesült ÁllamokNo longer taking part
- Cleaver Medical GroupCumming, Egyesült ÁllamokNo longer taking part
- Wayne State University Physician Group DermatologyDearborn, Egyesült ÁllamokNo longer taking part
- Empire DermatologyEast Syracuse, Egyesült ÁllamokNo longer taking part
- Encore Medical Research LLCHollywood, Egyesült ÁllamokNo longer taking part
- Cahaba DermatologyHoover, Egyesült ÁllamokNo longer taking part
- Center for Clinical StudiesHouston, Egyesült ÁllamokNo longer taking part
- University of California, IrvineIrvine, Egyesült ÁllamokNo longer taking part
- Options Research Group, LlcKokomo, Egyesült ÁllamokNo longer taking part
- JDR Dermatology ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
- Dermatology and Surgery Specialists of North AtlantaMarietta, Egyesült ÁllamokNo longer taking part
- Savin Medical Group, RcMiami, Egyesült ÁllamokNo longer taking part
- Skin Research of South Florida, LlcMiami, Egyesült ÁllamokNo longer taking part
- San Marcus Research Clinic, Inc.Miami Lakes, Egyesült ÁllamokNo longer taking part
- International Clinical Research - Tennessee LLCMurfreesboro, Egyesült ÁllamokNo longer taking part
- Sadick Dermatology Sadick Research GroupNew York, Egyesült ÁllamokNo longer taking part
- Dermatology Associates of Plymouth MeetingPlymouth Meeting, Egyesült ÁllamokNo longer taking part
- Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building LocationRichmond, Egyesült ÁllamokNo longer taking part
- Medisearch Clinical TrialsSaint Joseph, Egyesült ÁllamokNo longer taking part
- Progressive Clinical ResearchSan Antonio, Egyesült ÁllamokNo longer taking part
- Clinical Science Institute Clinical Research Specialists IncSanta Monica, Egyesült ÁllamokNo longer taking part
- Cura Clinical ResearchSherman Oaks, Egyesült ÁllamokNo longer taking part
- Dermatology Specialists of SpokaneSpokane, Egyesült ÁllamokNo longer taking part
- Pivotal Research SolutionsStonecrest, Egyesült ÁllamokNo longer taking part
- Derm Research Center of New York, Inc.Stony Brook, Egyesült ÁllamokNo longer taking part
- Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale CenterSunnyvale, Egyesült ÁllamokNo longer taking part
- ForCare Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Olympian Clinical ResearchTampa, Egyesült ÁllamokNo longer taking part
- Revival Research Institute, Llc DermatologyTroy, Egyesült ÁllamokNo longer taking part
- Jordan Valley Dermatology CenterWest Jordan, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Incyte Corporation
- Azonosító
- NCT06113445EU 2023-505782-86-00
- A regiszteradat frissítve
- 2026. augusztus 25.
- Eredeti leírás
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Bevonási feltételek: Aged ≥ 18 years; Clinical diagnosis of nonsegmental vitiligo and meet the following:; T-BSA ≥ 5%; T-VASI score ≥ 4; F-BSA ≥ 0.5%; F-VASI score ≥ 0.5; Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit; Willingness to avoid pregnancy or fathering children.
Kizáró feltételek: Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1; Spontaneous and significant repigmentation within 6 months prior to screening; Other forms of vitiligo or skin depigmentation disorders; History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo; Evidence of infection with TB, HBV, HCV or HIV; History of failure to JAK inhibitor treatment of any inflammatory disease; Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies; Laboratory values outside of the protocol-defined ranges; Other protocol-defined Inclusion/Exclusion Criteria may apply; Clinically significant abnormal TSH or free T4 at screening; Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®; Women who are pregnant, considering pregnancy, or breast feeding.