A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

INCB 54707-206

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.

2021-11-04

2023-08-11

2024-04-14

Active (not recruiting)

Early phase I

146

Inclusion Criteria: * Clinical diagnosis of PN for at least 3 months before screening. * Inadequate response or intolerant to ongoing or prior PN therapy. * ≥ 20 pruriginous lesions 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 146, 'type': 'ACTUAL'}}

2024-02-28