Clinical trial NCT06113471: A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
Official title: A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: NonSegmental Vitiligo
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)
timeFrame: Week 52
measure: Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
timeFrame: Week 52
measure: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)
timeFrame: Week 52
measure: Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5
timeFrame: Week 52 and Week 104
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 104 and 30 days
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
timeFrame: Week 52 and Week 104
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
timeFrame: Week 104
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)
timeFrame: Week 52 and Week 104
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
timeFrame: Week 104
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
timeFrame: Week 104
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
timeFrame: Week 52 and Week 104
measure: Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1
timeFrame: Week 52 and Week 104
measure: Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category
timeFrame: Week 52 and Week 104
measure: Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)
timeFrame: Week 52 and Week 104
measure: Proportion of participants in each Static Investigator Global Assessment (SIGA) category
timeFrame: Week 52 and Week 104
measure: Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2
timeFrame: Week 52 and Week 104
measure: Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category
timeFrame: Week 52 and Week 104
measure: Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2
timeFrame: Week 52 and Week 104
measure: Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category
timeFrame: Week 52 and Week 104
measure: Proportion of participants in each category for the color-matching question
timeFrame: Week 52 and Week 104
measure: Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)
timeFrame: Week 52 and Week 104
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales
timeFrame: Week 52 and Week 104
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Hospital-Whitaker Clinic
state: Alabama
city: Montgomery
country: United States
facility: C2 Research Center, Llc
state: Alabama
city: Fountain Valley
country: United States
facility: First Oc Dermatology Research Inc
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research Llc
state: California
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, Llc
state: Florida
city: Boynton Beach
country: United States
facility: Total Vein and Skin Llc
state: Florida
city: Coral Gables
country: United States
facility: Driven Research Llc
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education Llc
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Skin Research Llc
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc
state: Florida
city: Marietta
country: United States
facility: Dermatology and Surgery Specialists of North Atlanta
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research Pc
state: Georgia
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine Iusm Indianapolis
state: Indiana
city: Baton Rouge
country: United States
facility: Delricht Research
state: Louisiana
city: Glenn Dale
country: United States
facility: Callender Dermatology and Cosmetic Center
state: Maryland
city: Rockville
country: United States
facility: Aesthetic and Dermatology Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Portsmouth
country: United States
facility: Allcutis Research, Llc
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, Pc
state: Oregon
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Heights Dermatology and Aesthetic Center
state: Texas
city: Houston
country: United States
facility: University of Texas, Md Anderson Cancer
state: Texas
city: Plano
country: United States
facility: Innovative Dermatology: Legacy Medical Village
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Dupnitsa
country: Bulgaria
facility: Medical Center Asklepii Ood
city: Sliven
country: Bulgaria
facility: Medical Center Unimed Eood
city: Sofia
country: Bulgaria
facility: Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An
city: Sofia
country: Bulgaria
facility: Aleksandrovska University Hospital
city: Sofia
country: Bulgaria
facility: 28 Diagnostic and Consultative Center
city: Vancouver
country: Canada
facility: British Columbia'S Centre For Dermatologic Science - the Skin Care Centre
state: British Columbia
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DERMEDGE
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Quebec City
country: Canada
facility: Centre de Recherche Dermatologique de Quebec
state: Quebec
city: Brest
country: France
facility: Chru Morvan/Chu Brest Hopital Morvan
city: Le Mans
country: France
facility: Centre Hospitalier - Le Mans
city: Martigues
country: France
facility: Cabinet Medical- Chemin de Paradis
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice,Hopital L Archet
city: Rouen Cedex
country: France
facility: Hopital Charles Nicolle
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Debrecen
country: Hungary
facility: Orvostudomanyi Kutato Es Fejleszto Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Szombathely
country: Hungary
facility: Markusovszky Teaching Hospital
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
city: Catania
country: Italy
facility: Azienda Policlinico Vittorio Emanuele
city: Milano
country: Italy
facility: Fondazione Irccs Ca Granda Ospedale Maggiore
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs
city: Rozzano
country: Italy
facility: Irccs Istituto Clinico Humanitas
city: Gdansk
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial W Gdansku
city: Gdynia
country: Poland
facility: Synexus Gdynia
city: Katowice
country: Poland
facility: Provita Sp.Zo.O. Centrum Medyczne Angelius
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. Z O.O.
city: Kielce
country: Poland
facility: Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
city: Lodz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Dermed Centrum Medyczne Sp. Z O.O.
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
city: Skierniewice
country: Poland
facility: Velocity Clinical Research, Skierniewice
city: Szczecin
country: Poland
facility: Laser Clinic
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
city: Warsaw
country: Poland
facility: Centrum Medyczne Evimed
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. Z O.O.
city: Wrocaw
country: Poland
facility: Futuremeds Targowek Centrum Medyczne Amed Warszawa Targowek
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
city: Wroclaw
country: Poland
facility: Dermmedica Sp. Z O.O.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester-Leicester Royal Infirmary (Lri)
city: London
country: United Kingdom
facility: Whipps Cross University Hospital - Barts Health Nhs Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals - Treatment Center
city: Walsall
country: United Kingdom
facility: Royal Wolverhampton Nhs Trust
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: