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

• Status: Recruiting
• Trial end date: 2023-06-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Clinical diagnosis of PN for at least 3 months before screening.

• Inadequate response or intolerant to ongoing or prior PN therapy.

• ≥ 20 nodules on ≥ 2 different body regions at screening and Day 1.

• Willingness to avoid pregnancy or fathering children

• Further inclusion criteria apply.

Exclusion Criteria:

• Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.

• Current use of a medication known to cause pruritus.

• 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.