Clinical trial NCT06113445: A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
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: 467
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-VASI90)
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: Hoover
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Clinical Research Specialists Inc
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Sunnyvale
country: United States
facility: Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center
state: California
city: Cape Coral
country: United States
facility: Renaissance Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, Llc
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic Inc.
state: Florida
city: Miami
country: United States
facility: Savin Medical Group, Rc
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida, Llc
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Cumming
country: United States
facility: Cleaver Medical Group
state: Georgia
city: Marietta
country: United States
facility: Dermatology and Surgery Specialists of North Atlanta
state: Georgia
city: Stonecrest
country: United States
facility: Pivotal Research Solutions
state: Georgia
city: Kokomo
country: United States
facility: Options Research Group, Llc
state: Indiana
city: Beverly
country: United States
facility: Allcutis Research, Llc
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group Inc
state: Michigan
city: Dearborn
country: United States
facility: Wayne State University Physician Group Dermatology
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, Llc Dermatology
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: Jdr Dermatology Research
state: Nevada
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: New York
country: United States
facility: Sadick Dermatology Sadick Research Group
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York Inc
state: New York
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Bellaire
country: United States
facility: University of Texas Physicians - Bellaire Station
state: Texas
city: Houston
country: United States
facility: Center For Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Brussel/ Brussels/bruxelles
country: Belgium
facility: Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (Uz Gent)
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Woluwe-saint-lambert
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Burlington
country: Canada
facility: Leader Research
state: Ontario
city: London
country: Canada
facility: Dermeffects
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Care Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Siena Medical Research Corporation
state: Ontario
city: Peterborough
country: Canada
facility: Skin Health
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Bordeaux Cedex
country: France
facility: Centre Hospitalier Universitaire (Chu) - Hopital Henri Mondor
city: Bordeaux Cedex
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
city: Reims
country: France
facility: Clinique de Courlancy
city: Toulouse
country: France
facility: Hopital Larrey
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Frankfurt Am Main
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe University
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen Gmbh
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist
city: Memmingen
country: Germany
facility: Beldio Research Gmbh
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Minamikoshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama-shi
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinagawa-ku
country: Japan
facility: Ntt Medical Center Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: National University Corporation - Tokyo Medical and Dental University (Tmdu)
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital
city: Deleg. Cuauhtemoc
country: Mexico
facility: Trials in Medicine S.C.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas A La Neurociencia A.C
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)
city: Providencia 5TA Seccion
country: Mexico
facility: Grupo Clínico Catei Sc
city: Amsterdam
country: Netherlands
facility: Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For
city: Bergen Op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
city: Chorzow
country: Poland
facility: Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
city: Czestochowa
country: Poland
facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial W Katowicach
city: Lodz
country: Poland
facility: Synexus Polska Sp Z Oo Oddzial W Lodzi
city: Osielsko
country: Poland
facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
city: Warsaw
country: Poland
facility: Etg Warszawa
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Mswia
city: Warszawa
country: Poland
facility: Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial W Warszawie
city: Wrocaw
country: Poland
facility: Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol (Hugtp)
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra (Cun)
city: Manises
country: Spain
facility: Hospital de Manises
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: