Phase 2
N=171
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
NonSegmental Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT04818346 ↗Enrolled (actual)
171
Serious AEs
1.3%
Results posted
Jul 2023
Primary outcome: Primary: Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 — 2.29; -19.12; -17.78; -15.73 percent change — p=0.0015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCB054707 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 |
2.29; -19.12; -17.78; -15.73 | 0.0015 sig |
| SECONDARY Percentage of Participants Achieving T-VASI50 at Week 24 |
2.3; 9.3; 11.6; 4.8 | 0.3574 |
| SECONDARY Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
24; 29; 30; 35 | — |
| SECONDARY Extension Period: Number of Participants With Any TEAE |
27; 28; 21; 31 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04818346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.