A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

NonSegmental Vitiligo Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113471
• Other study ID #: INCB54707-304
• Secondary ID: 2023-506011-18-0
• Status: Recruiting
• Phase: Phase 3
• Start date: November 27, 2023
• Est. completion date: May 17, 2027

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: May 17, 2027
• Est. primary completion date: May 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Other forms of vitiligo or skin depigmentation disorders.

• Clinically significant abnormal TSH or free T4 at screening.

• Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.

• Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.

• History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.

• Spontaneous and significant repigmentation within 6 months prior to screening.

• Women who are pregnant, considering pregnancy, or breast feeding.

• 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.

• Evidence of infection with TB, HBV, HCV or HIV.

• History of failure to JAK inhibitor treatment of any inflammatory disease.

• Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Related Conditions & MeSH terms

• NonSegmental Vitiligo
• Vitiligo

Intervention

Drug:
• Povorcitinib
Oral, Tablet
• Placebo
Oral, Tablet

Locations

Country	Name	City	State
Bulgaria	Medical Center Asklepii Ood	Dupnitsa
Bulgaria	Mc Unimed	Sliven
Bulgaria	28 Diagnostic and Consultative Center	Sofia
Bulgaria	Aleksandrovska University Hospital	Sofia
Bulgaria	Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An	Sofia
Canada	Lynderm Research Inc	Markham	Ontario
Canada	DERMEDGE	Mississauga	Ontario
Canada	Centre de Recherche Dermatologique de Quebec	Quebec City	Quebec
Canada	Research Toronto	Toronto	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	British Columbia'S Centre For Dermatologic Science - the Skin Care Centre	Vancouver	British Columbia
France	Chru Morvan/Chu Brest Hopital Morvan	Brest
France	Centre Hospitalier - Le Mans	Le Mans
France	Cabinet Medical- Chemin de Paradis	Martigues
France	Centre Hospitalier Universitaire de Nice,Hopital L Archet	Nice
France	Hopital Charles Nicolle	Rouen Cedex
Germany	Fachklinik Bad Bentheim Dermatologie	Bad Bentheim
Germany	Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	University Hospital Carl Gustav Carus	Dresden
Germany	Universitatsklinikum Hamburg	Hamburg
Germany	Dermatologische Gemeinschaftspraxis	Mahlow
Germany	Universitatsklinikum Munster	Muenster
Hungary	Debreceni Egyetem	Debrecen
Hungary	Orvostudomanyi Kutato Es Fejleszto Kft	Debrecen
Hungary	Obudai Egeszsegugyi Centrum - Dunaujvaros	Dunaujvaros
Hungary	Markusovszky Teaching Hospital	Szombathely
Italy	Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia	Brescia
Italy	Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania	Catania
Italy	Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Fondazione Policlinico Universitario Agostino Gemelli Irccs	Rome
Italy	Irccs Istituto Clinico Humanitas	Rozzano
Poland	Synexus - Polska Sp Z Oo Oddzial W Gdansksynexus Affiliate - Bialystok - Clinicmed Daniluk Nowak Spo	Gdansk
Poland	Synexus Gdynia	Gdynia
Poland	Pro Familia Altera Sp. Z O.O.	Katowice
Poland	Provita Sp.Zo.O. Centrum Medyczne Angelius	Katowice
Poland	Prywatny Gabinet Dermatologiczny Elzbieta Klujszo	Kielce
Poland	Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak	Lodz
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.	Lodz
Poland	Etg Skierniewice	Skierniewice
Poland	Laser Clinic	Szczecin
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.	Tarnow
Poland	Centrum Medyczne Evimed	Warsaw
Poland	Klinika Ambroziak Sp. Z O.O.	Warszawa
Poland	Royalderm Agnieszka Nawrocka	Warszawa
Poland	Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek	Wrocaw
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Dermmedica Sp. Z O.O.	Wroclaw
Poland	Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu	Wroclaw
United Kingdom	Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust	Ipswich
United Kingdom	University Hospitals of Leicester-Leicester Royal Infirmary (Lri)	Leicester
United Kingdom	Barts Health Nhs Trust - Whipps Cross University Hospital	London
United Kingdom	Nottingham University Hospitals - Treatment Center	Nottingham
United Kingdom	Royal Wolverhampton Nhs Trust	Walsall
United States	Delricht Research	Baton Rouge	Louisiana
United States	University of Alabama At Birmingham Hospital-Whitaker Clinic	Birmingham	Alabama
United States	Skin Care Research, Llc	Boca Raton	Florida
United States	Total Vein and Skin Llc	Boynton Beach	Florida
United States	Remington-Davis Clinical Research	Columbus	Ohio
United States	Driven Research Llc	Coral Gables	Florida
United States	Florida Academic Centers Research and Education Llc	Coral Gables	Florida
United States	Pediatric Skin Research Llc	Coral Gables	Florida
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Tien Q Nguyen Md Inc	Fountain Valley	California
United States	Center For Dermatology Clinical Research, Inc	Fremont	California
United States	Callender Dermatology and Cosmetic Center	Glenn Dale	Maryland
United States	Heights Dermatology and Aesthetic Center	Houston	Texas
United States	University of Texas, Md Anderson Cancer	Houston	Texas
United States	Marvel Clinical Research Llc	Huntington Beach	California
United States	Indiana University School of Medicine Iusm Indianapolis	Indianapolis	Indiana
United States	Dermatology Research Associates	Los Angeles	California
United States	Vitiligo & Pigmentation Institute of Southern California	Los Angeles	California
United States	C2 Research Center, Llc	Montgomery	Alabama
United States	Weill Cornell Medicine	New York	New York
United States	Kgl Skin Study Center	Newtown Square	Pennsylvania
United States	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas
United States	Oregon Medical Research Center, Pc	Portland	Oregon
United States	Allcutis Research, Inc Portsmouth	Portsmouth	New Hampshire
United States	Aesthetic and Dermatology Center	Rockville	Maryland
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Advanced Medical Research Pc	Sandy Springs	Georgia
United States	Premier Clinical Research	Spokane	Washington
United States	Clinical Trials Research Institute	Thousand Oaks	California
United States	Dundee Dermatology	West Dundee	Illinois
United States	Metabolic Research Institute Inc	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  France,  Germany,  Hungary,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Achieving a = 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)	=75% improvement in facial Vitiligo Area Scoring Index.	Week 52
Secondary	Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)	Percentage change from Baseline in total body Vitiligo Area Scoring Index.	Week 52
Secondary	Proportion of Participants Achieving a = 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)	=50% improvement in total body Vitiligo Area Scoring Index.	Week 52
Secondary	Proportion of Participants Achieving a = 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)	=75% improvement in total body Vitiligo Area Scoring Index.	Week 52
Secondary	Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5	VNS is a participant reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable.	Week 52 and Week 104
Secondary	Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to Week 104 and 30 days
Secondary	Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)	=50% improvement in facial Vitiligo Area Scoring Index.	Week 52 and Week 104
Secondary	Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)	=75% improvement in facial Vitiligo Area Scoring Index.	Week 104
Secondary	Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)	=90% improvement in facial Vitiligo Area Scoring Index.	Week 52 and Week 104
Secondary	Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)	=50% improvement in total body Vitiligo Area Scoring Index.	Week 104
Secondary	Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)	=75% improvement in total body Vitiligo Area Scoring Index.	Week 104
Secondary	Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)	=90% improvement in total body Vitiligo Area Scoring Index.	Week 52 and Week 104
Secondary	Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1	Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).	Week 52 and Week 104
Secondary	Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category	Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).	Week 52 and Week 104
Secondary	Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)	Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).	Week 52 and Week 104
Secondary	Proportion of participants in each Static Investigator Global Assessment (SIGA) category	Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).	Week 52 and Week 104
Secondary	Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2	F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).	Week 52 and Week 104
Secondary	Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category	F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).	Week 52 and Week 104
Secondary	Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2	T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).	Week 52 and Week 104
Secondary	Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category	T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).	Week 52 and Week 104
Secondary	Proportion of participants in each category for the color-matching question	Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor.	Week 52 and Week 104
Secondary	Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)	VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time").	Week 52 and Week 104
Secondary	Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales	HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).	Week 52 and Week 104