Efficacy and Safety Evaluation of Povorcitinib in Adult Patients with Nonsegmental Vitiligo: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study

Trial ID: 2023-506011-18-00
Protocol: INCB 54707-304
Sponsor: Incyte Corp.

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Diseases & Conditions

Vitiligo

Objectives

The primary objective of this study is to compare the **efficacy** of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo. This objective is clinically relevant as it aims to evaluate the potential of povorcitinib as a therapeutic option for nonsegmental vitiligo, a condition characterized by the loss of skin pigmentation, which can significantly impact patients' quality of life.

Secondary objectives include:

Further comparing the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo.
Comparing participants' perception of treatment response for povorcitinib versus placebo at Week 52.

Participants

The clinical trial involves a total of **163 participants** diagnosed with **nonsegmental vitiligo**. The study population includes both male and female adults aged 18 years and older. Participants were selected based on their ability to comprehend and sign an informed consent form, as well as their clinical diagnosis of nonsegmental vitiligo. The trial requires participants to discontinue all treatments for vitiligo from the screening phase through the final safety follow-up visit. Additionally, participants must agree to avoid pregnancy or fathering children during the study period. The trial population includes individuals from a vulnerable population, although specific lifestyle considerations such as diet or physical activity are not detailed. The selection criteria ensure that participants are willing and able to comply with the study protocol and procedures, including photography.

Plans and Procedures

The clinical trial is a **Phase 3**, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of **Povorcitinib** in adult participants with nonsegmental **vitiligo**. The trial is set to last for 52 weeks, with the primary objective being to compare the efficacy of Povorcitinib to placebo at Week 52. Participants will be randomly assigned to receive either Povorcitinib or a placebo, both administered orally in tablet form. The primary endpoint is the proportion of participants achieving a ≥ 75% improvement from baseline in the Face Vitiligo Area Scoring Index (F-VASI75) at Week 52. Secondary endpoints include percentage change from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) and other related measures.

The trial will commence with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥ 18 years), clinical diagnosis of nonsegmental vitiligo, and willingness to comply with study protocols. Participants must agree to discontinue all other treatments for vitiligo from screening through the final safety follow-up visit. The study will include several follow-up visits to monitor progress and ensure adherence to the protocol. The end-of-study visit will occur at Week 52, where final assessments will be conducted to evaluate the primary and secondary endpoints.

Participant involvement is expected to last for the entire 52-week duration of the trial. However, conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or any adverse events that may compromise participant safety. The trial is scheduled to start recruitment in March 2024, with an estimated end date in June 2027. The study is not classified as a low-intervention trial and follows the guidelines for a Phase 3 trial under Category 2 per EMA guidance.

Treatment

The clinical trial involves the administration of **Povorcitinib**, an investigational medication, in the form of a **tablet**. Povorcitinib is a chemical substance developed by Incyte Corporation, identified by the sponsor product code INCB054707. The active substance in Povorcitinib is also named Povorcitinib, with the European substance number SUB261823. The medication is administered orally. The trial is designed to evaluate the efficacy and safety of Povorcitinib over a 52-week period in participants with nonsegmental vitiligo. The dosing schedule and specific dosage amounts are not explicitly detailed in the provided data.

In addition to the experimental treatment, a **placebo** is used as a comparator in this double-blind study. The placebo is designed to match the pharmaceutical form of Povorcitinib, although specific details regarding its composition are not provided. The placebo is administered orally, in alignment with the administration route of the active treatment. The use of a placebo allows for the assessment of the true efficacy of Povorcitinib by providing a control group for comparison.

Efficacy

The efficacy of **Povorcitinib** in the treatment of nonsegmental vitiligo will be assessed in a Phase 3, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the proportion of participants achieving a ≥ 75% improvement from baseline in the Face Vitiligo Area Scoring Index (F-VASI75) at Week 52. Secondary endpoints include the percentage change from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI) at Week 52, the proportion of participants achieving ≥ 50% improvement from baseline in T-VASI50, the proportion achieving ≥ 75% improvement in T-VASI75, and the proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 52.

These efficacy parameters will be measured and collected at the specified timepoint of Week 52. The Face Vitiligo Area Scoring Index (F-VASI) and Total Body Vitiligo Area Scoring Index (T-VASI) are validated scales used to quantify the extent and severity of vitiligo. The Vitiligo Noticeability Scale (VNS) is a patient-reported outcome measure assessing the visibility of vitiligo. The analysis of these endpoints will provide insights into the efficacy of Povorcitinib compared to placebo in achieving significant improvements in vitiligo symptoms over the 52-week treatment period.

Inclusion and Exclusion Criteria

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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.

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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 (QTc) > 480 milliseconds (> 470 milliseconds in the UK only) 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 5.2.14 of the protocol)
At the screening visit, any of the laboratory abnormalities defined in Table 10 of the protocol
Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2. of the protocol
Active human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3 of the protocol).
Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions or leukotrichia in more than 33% of the total body (including the face) surface area affected with vitiligo lesions as assessed at screening.
Had ≥ 3 laser hair removal treatments of an area to be treated for vitiligo.
Concurrent enrollment in another clinical study.

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
Bulgaria	Not Recruiting	11 Mar 2024	23
France	Not Recruiting	11 Mar 2024	37
Germany	Not Recruiting	11 Mar 2024	34
Hungary	Not Recruiting	11 Mar 2024	20
Italy	Not Recruiting	11 Mar 2024	39
Poland	Not Recruiting	11 Mar 2024	128