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

Incyte

Status and phase: Completed; Phase 2

Conditions: NonSegmental Vitiligo

Treatments: Drug: INCB054707; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04818346

INCB 54707-205

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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171 participants in 4 patient groups, including a placebo group

INCB054707 Dose A followed by Dose C

Experimental group

Description:

Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Treatment:

Drug: INCB054707

INCB054707 Dose B

Experimental group

Description:

Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).

Treatment:

Drug: INCB054707

INCB054707 Dose C

Experimental group

Description:

Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).

Treatment:

Drug: INCB054707

Placebo followed by INCB054707 Dose C

Placebo Comparator group

Description:

Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Treatment:

Drug: Placebo