Selective Treatment of Oral Povorcitinib in Vitiligo Study 2 (STOP-V2)

Phase 1

Recruiting

• Conditions: Vitiligo; MedDRA version: 21.1Level: PTClassification code: 10047642Term: Vitiligo Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-506011-18-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study., Aged = 18 years at the time of consent., Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol, 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 based on the criteria listed in the section 5.1.5 of the protocol., Willing and able to comply with the study Protocol and procedures, including photography.

Exclusion Criteria

Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)., Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or risk of reactivation (see Section 8.3.5.4 of the protocol)., Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class., Clinically significant abnormal thyroid-stimulating hormone (TSH) or free thyroxine (T4) at screening as determined by the investigator., Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data., The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code., Use of laser or light-based treatment (phototherapy), including tanning beds, within 8 weeks prior to Day 1., Use of dihydroxyacetone (generally present in self-tanning products) within 4 weeks prior to Day 1., Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (monobenzone)., History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo., Spontaneous and significant repigmentation within 6 months prior to screening (eg, repigmentation without any treatment and significant in amount as determined by the investigator)., A screening 12-lead electrocardiogram (ECG) that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome) or QT interval corrected > 480 milliseconds at screening., Women who are pregnant, considering pregnancy, or breastfeeding., Concurrent conditions or history of other diseases, as listed in section 5.2.9 of the protocol, The following participants are excluded in the EU: participants with increased risks of events associated with JAK inhibitors (specifically increased risk of major cardiovascular events [eg, > 65 years of age and current or past longtime smokers] and venous thromboembolism) unless the benefit/risk profile is still favorable in the opinion of the investigator., Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit., History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit., History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or any other inflammatory condition., Receipt of medical treatment or investigational drugs within the following interval prior to Day 1 (as outlined in section 5.2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo.;Secondary Objective: To further compare the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo., To compare participants' perception of treatment response for povorcitinib versus placebo at Week 52.;Primary end point(s): Proportion of participants achieving = 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI75) at Week 52.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 52.;Secondary end point(s):Proportion of participants achieving = 50% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI50) at Week 52;Secondary end point(s):Proportion of participants achieving = 75% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI75) at Week 52;Secondary end point(s):Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of 4 – A lot less noticeable or 5 – No longer noticeable at Week 52.