A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
A legfontosabb adatok
- Hol
- Baton Rouge, Birmingham, Boca Raton, Boynton Beach, Columbus, Coral Gables, Dallas, Detroit, Fountain Valley, Fremont, Glenn Dale, Houston, Huntington Beach, Indianapolis, Los Angeles, Marietta, Montgomery, New York, Plano, Portland, Portsmouth, Rockville, San Antonio, Sandy Springs, Spokane, Thousand Oaks, West Dundee és West Palm Beach (Egyesült Államok)Mind a 33 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- DelRicht ResearchBaton Rouge, Egyesült ÁllamokNo longer taking part
- University of Alabama At Birmingham Hospital-Whitaker ClinicBirmingham, Egyesült ÁllamokNo longer taking part
- Skin Care Research, LLCBoca Raton, Egyesült ÁllamokNo longer taking part
- Total Vein and Skin LLCBoynton Beach, Egyesült ÁllamokNo longer taking part
- Remington Davis Clinical ResearchColumbus, Egyesült ÁllamokNo longer taking part
- Driven Research LLCCoral Gables, Egyesült ÁllamokNo longer taking part
- Florida Academic Centers Research and Education, LLCCoral Gables, Egyesült ÁllamokNo longer taking part
- Pediatric Skin Research LLCCoral Gables, Egyesült ÁllamokNo longer taking part
- Dermatology Treatment and Research CenterDallas, Egyesült ÁllamokNo longer taking part
- Henry Ford Health SystemDetroit, Egyesült ÁllamokNo longer taking part
- First Oc Dermatology Research IncFountain Valley, Egyesült ÁllamokNo longer taking part
- Center For Dermatology Clinical Research, Inc.Fremont, Egyesült ÁllamokNo longer taking part
- Callender Dermatology and Cosmetic CenterGlenn Dale, Egyesült ÁllamokNo longer taking part
- Heights Dermatology and Aesthetic CenterHouston, Egyesült ÁllamokNo longer taking part
- University of Texas, Md Anderson CancerHouston, Egyesült ÁllamokNo longer taking part
- Marvel Clinical Research, LLCHuntington Beach, Egyesült ÁllamokNo longer taking part
- Indiana University School of Medicine Iusm IndianapolisIndianapolis, Egyesült ÁllamokNo longer taking part
- Dermatology Research AssociatesLos Angeles, Egyesült ÁllamokNo longer taking part
- Vitiligo & Pigmentation Institute of Southern CaliforniaLos Angeles, Egyesült ÁllamokNo longer taking part
- Dermatology and Surgery Specialists of North AtlantaMarietta, Egyesült ÁllamokNo longer taking part
- C2 Research Center, LLCMontgomery, Egyesült ÁllamokNo longer taking part
- Weill Cornell Medical CollegeNew York, Egyesült ÁllamokNo longer taking part
- Innovative Dermatology: Legacy Medical VillagePlano, Egyesült ÁllamokNo longer taking part
- Oregon Medical Research Center PCPortland, Egyesült ÁllamokNo longer taking part
- Allcutis Research, LlcPortsmouth, Egyesült ÁllamokNo longer taking part
- Aesthetic and Dermatology CenterRockville, Egyesült ÁllamokNo longer taking part
- Dermatology Clinical Research Center of San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
- Texas Dermatology and Laser SpecialistsSan Antonio, Egyesült ÁllamokNo longer taking part
- Advanced Medical Research, PC.Sandy Springs, Egyesült ÁllamokNo longer taking part
- Premier Clinical ResearchSpokane, Egyesült ÁllamokNo longer taking part
- Clinical Trials Research InstituteThousand Oaks, Egyesült ÁllamokNo longer taking part
- Dundee DermatologyWest Dundee, Egyesült ÁllamokNo longer taking part
- Metabolic Research Institute, IncWest Palm Beach, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Incyte Corporation
- Azonosító
- NCT06113471EU 2023-506011-18-00
- A regiszteradat frissítve
- 2026. március 31.
- 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.