A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

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: NCT06113445
• Other study ID #: INCB54707-303
• Secondary ID: 2023-505782-86-0
• Status: Recruiting
• Phase: Phase 3
• Start date: November 29, 2023
• Est. completion date: May 8, 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 8, 2027
• Est. primary completion date: May 9, 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
Belgium	Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liege
Belgium	Cliniques Universitaires Ucl Saint-Luc	Woluwe-saint-lambert
Canada	Leader Research	Burlington	Ontario
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Dermeffects	London	Ontario
Canada	North York Research Inc.	North York	Ontario
Canada	Care Clinic	Ottawa	Ontario
Canada	Siena Medical Research Corporation	Ottawa	Ontario
Canada	Skin Health	Peterborough	Ontario
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	Alliance Clinical Trials	Waterloo	Ontario
France	Bordeaux Chu Hopital Saint - Andre	Bordeaux Cedex
France	Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor	Bordeaux Cedex
France	Clinique de Courlancy	Reims
France	Centre Hospitalier Universitaire (Chu)	Toulouse
Germany	Universitatsklinikum Erlangen Hautklinik	Erlangen
Germany	Klinikum Der Johann Wolfgang Goethe University	Frankfurt Am Main
Germany	Derma-Study-Center Friedrichshafen Gmbh	Friedrichshafen
Germany	Dermatologische Gemeinschaftspraxis Dres. Quist	Mainz
Germany	Beldio Research Gmbh, Dr. Schwinn,	Memmingen
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	St. Marianna University School of Medicine Hospital	Kawasaki
Japan	Kobe University Hospital	Kobe
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Dokkyo Medical University Saitama Medical Center	Minamikoshigaya
Japan	Nagasaki University Hospital	Nagasaki-shi
Japan	Nagoya City University Hospital	Nagoya
Japan	Kochi Medical School Hospital	Nankoku
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	National Hospital Organization Okayama Medical Center	Okayama-shi
Japan	Tohoku University Hospital	Sendai
Japan	Ntt Medical Center Tokyo	Shinagawa-ku
Japan	Tokyo Medical University Hospital	Shinjuku-ku
Japan	Osaka University Hospital	Suita
Japan	National University Corporation - Tokyo Medical and Dental University (Tmdu)	Tokyo
Japan	Juntendo University Urayasu Hospital	Urayasu
Japan	Yamagata University Hospital	Yamagata-shi
Mexico	Trials in Medicine S.C.	Cuauhtemoc
Mexico	Instituto de Investigaciones Aplicadas A La Neurociencia A.C	Durango
Mexico	Grupo Clínico Catei Sc	Guadalajara
Mexico	Centro de Dermatologia de Monterrey	Monterrey
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey
Mexico	Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)	Morelia
Netherlands	Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For	Amsterdam
Netherlands	Bravis Ziekenhuis	Bergen Op Zoom
Poland	Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska	Chorzow
Poland	Synexus Polska Sp Z Oo Oddzial W Czestochowie	Czestochowa
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Synexus Polska Sp. Z O.O. Oddzial W Katowicach	Katowice
Poland	Synexus Polska Sp Z Oo Oddzial W Lodzi	Lodz
Poland	Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski	Osielsko
Poland	Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski
Poland	Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie	Rzeszow
Poland	Etg Warszawa	Warsaw
Poland	Carpe Diem Centrum Medycyny Estetycznej	Warszawa
Poland	Csk Mswia Centralny Szpital Kliniczny Mswia	Warszawa
Poland	Synexus Polska Sp. Z O.O. Oddzial Warszawie	Warszawa
Poland	Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia	Wrocaw
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon
Spain	Germans Trias I Pujol	Badalona
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Clinical Universidad de Navarra Madrid	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital de Manises	Manises
United States	Great Lakes Research Group Inc	Bay City	Michigan
United States	University of Texas Physicians - Bellaire Station	Bellaire	Texas
United States	Allcutis Research Inc Beverly	Beverly	Massachusetts
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	Renaissance Research	Cape Coral	Florida
United States	Cleaver Medical Group	Cumming	Georgia
United States	Wayne State University Physician Group Dermatology	Dearborn	Michigan
United States	Empire Dermatology	East Syracuse	New York
United States	Encore Medical Research, Llc Hollywood	Hollywood	Florida
United States	Cahaba Dermatology	Hoover	Alabama
United States	Center For Clinical Studies	Houston	Texas
United States	University of California Irvine	Irvine	California
United States	Options Research Group, Llc	Kokomo	Indiana
United States	Jdr Dermatology Research	Las Vegas	Nevada
United States	Savin Medical Group, Rc	Miami	Florida
United States	Skin Research of South Florida, Llc	Miami	Florida
United States	San Marcus Research Clinic Inc.	Miami Lakes	Florida
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Sadick Dermatology Sadick Research Group	New York	New York
United States	Dermatology Associates of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location	Richmond	Virginia
United States	Medisearch Clinical Trials	Saint Joseph	Missouri
United States	Progressive Clinical Research	San Antonio	Texas
United States	Clinical Science Institute Clinical Research Specialists Inc	Santa Monica	California
United States	Cura Clinical Research	Sherman Oaks	California
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Pivotal Research Solutions	Stonecrest	Georgia
United States	Derm Research Center of New York Inc	Stony Brook	New York
United States	Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center	Sunnyvale	California
United States	Forcare Clinical Research	Tampa	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Revival Research Institute, Llc Dermatology	Troy	Michigan
United States	Jordan Valley Dermatology Center	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Japan,  Mexico,  Netherlands,  Poland,  Spain, 

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-VASI90)	=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