Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Prurigo Nodularis PN INCB054707 chronic pruritus Prurigo Neurodermatitis

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Investigative Site US014 not yet accepting patients
    Sacramento California 95816 United States
  • Investigative Site US001 accepting new patients
    Fountain Valley California 92708 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
Sign up for this study
ID
NCT05061693
Phase
Phase 2 Prurigo Nodularis Research Study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated