A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
- Registration Number
- NCT04818346
- Lead Sponsor
- Incyte Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by INCB054707 Dose C Placebo Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). INCB054707 Dose B INCB054707 Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2). INCB054707 Dose A followed by Dose C INCB054707 Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). INCB054707 Dose C INCB054707 Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 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 Outcome Measures
Name Time Method Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) 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.
Extension Period: Number of Participants With Any TEAE 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.
Percentage of Participants Achieving T-VASI50 at Week 24 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.
Trial Locations
- Locations (31)
Investigative Site 010
🇺🇸Hoover, Alabama, United States
Investigative Site 015
🇺🇸Gilbert, Arizona, United States
Investigative Site 028
🇺🇸Scottsdale, Arizona, United States
Investigative Site 006
🇺🇸Irvine, California, United States
Investigative Site 009
🇺🇸Los Angeles, California, United States
Investigative Site 018
🇺🇸Los Angeles, California, United States
Investigative Site 017
🇺🇸Sacramento, California, United States
Investigative Site 032
🇺🇸Orange Park, Florida, United States
Investigative Site 005
🇺🇸Tampa, Florida, United States
Investigative Site 022
🇺🇸Tampa, Florida, United States
Scroll for more (21 remaining)Investigative Site 010🇺🇸Hoover, Alabama, United States