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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NonSegmental Vitiligo

In brief

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

Key facts

Study ID

NCT06113445

Run by

Incyte Corporation

People needed

467

Starts

2023-11-29

Expected to finish

2027-02-24

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Grupo Clínico Catei Sc — Providencia 5TA Seccion, Mexico
• Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For — Amsterdam, Netherlands
• Bravis Ziekenhuis — Bergen op Zoom, Netherlands
• Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska — Chorzów, Poland
• Synexus Polska Sp Z Oo Oddzial W Czestochowie — Częstochowa, 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 Świętokrzyski, Poland
• Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie — Rzeszów, Poland
• Panstwowy Instytut Medyczny Mswia — Warsaw, Poland
• Carpe Diem Centrum Medycyny Estetycznej — Warsaw, Poland
• Synexus Polska Sp. Z O.O. Oddzial W Warszawie — Warsaw, Poland
• Etg Warszawa — Warsaw, Poland
• Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia — Wrocaw, Poland
• Hospital Universitario Fundacion Alcorcon — Alcorcón, Spain
• Hospital Universitari Germans Trias I Pujol (Hugtp) — Badalona, Spain
• Hospital Clinic I Provincial de Barcelona — Barcelona, Spain
• Hospital Universitario Ramon Y Cajal — Madrid, Spain
• Clinica Universidad de Navarra (Cun) — Madrid, Spain
• Hospital de Manises — Manises, Spain
• Wayne State University Physician Group Dermatology — Dearborn, Michigan, United States
• Revival Research Institute, Llc Dermatology — Troy, Michigan, United States
• Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype) — Morelia, Mexico

Full record on ClinicalTrials.gov

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