Last updated 6 days ago

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

444 patients around the world

Available in Spain, Mexico, United States

Incyte Corporation

5Research sites

444Patients around the world

This study is for people with

Vitiligo

Generalized vitiligo

From 18 Years

All Gender

: 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.

: 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.

Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González

Av. Madero y Gonzalitos S/N, Mitras Centro, Monterrey, Nuevo León

Instituto de Investigaciones Aplicadas a la Neurociencia, A.C.

Luis Pasteur 205 Nte, Centro, Durango

CATEI - Centro de Atención en Enfermedades Inflamatorias

Calle Sta. Fe 3078, Providencia 5a Secc., 44638 Guadalajara, Jal., Mexico

Centro de Dermatologia de Monterrey

Av Paseo de los Leones 603-D, Mitras Centro, 64460 Monterrey, N.L

Clínica de Enfermedades Crónicas y de Procedimientos Especiales - CECYPE

C. Nicolás Bravo 1734, Villa Universidad, 58060 Morelia, Mich., Mexico

SponsorIncyte Corporation

Conditions

Generalized vitiligo

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06113445