Prurigo Nodularis (Incyte Study)

Study Description

Brief 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.

Condition or Disease

Prurigo Nodularis

Study Design

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date: November 4, 2021
Estimated Primary Completion Date: April 20, 2023
Estimated Study Completion Date: November 2, 2023

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants achieving ‚Č• 4-point improvement in Itch Numerical Rating Scale (NRS) score [¬†Time¬†Frame:¬†Week 16¬†]
    Itch NRS is an 11-point scale (0 to10) where 0 is “no itch” and 10 is the “worst itch imaginable”.

Secondary Outcome Measures

  1. Proportion of participants achieving Investigator’s Global Assessment Treatment Success (IGA-TS) [¬†Time¬†Frame:¬†Week 16¬†]
    Defined as IGA score of 0 or 1 with a ‚Č• 2-grade improvement from baseline
  2. Time to ‚Č• 4-point improvement from baseline in Itch NRS score [¬†Time¬†Frame:¬†Up to Week 48¬†]
    Defined as time taken for the participant to achieve a ‚Č•4 improvement in NRS scale compared to baseline
  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Eligibility Criteria

Ages Eligible for Study: 18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria

  • Clinical diagnosis of PN for at least 3 months before screening.
  • Inadequate response or intolerant to ongoing or prior PN therapy.
  • ‚Č• 20 nodules on ‚Č• 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.