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Completed

NCT Number: NCT04818346

A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.

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Key information

Conditions

NonSegmental Vitiligo

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site 020, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of nonsegmental vitiligo.
  • History of prior vitiligo treatment with a total duration of at least 3 months.
  • 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
  • Further inclusion criteria apply.

Exclusion criteria

  • Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
  • Uncontrolled thyroid function at screening as determined by the investigator.
  • Women who are pregnant (or who are considering pregnancy) or lactating.
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
  • Laboratory values outside of the protocol-defined ranges.
  • Further exclusion criteria apply.

Treatment and study plan

INCB054707

Drug

INCB054707 will be administered once daily

Other names: Povorcitinib

Placebo

Drug

Placebo or INCB054707 will be administered once daily

Primary outcomes

  1. Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

    Time frame: Baseline; Week 24

    The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.

Secondary outcomes

  1. Percentage of Participants Achieving T-VASI50 at Week 24

    Time frame: Baseline; Week 24

    T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.

  2. Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    Time frame: up to Week 24

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.

  3. Extension Period: Number of Participants With Any TEAE

    Time frame: from Week 25 up to Week 76

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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