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

  • STATUS
    Recruiting
  • End date
    May 3, 2024
  • participants needed
    140
  • sponsor
    Incyte Corporation
Updated on 28 October 2022
Investigator
Incyte Corporation Call Center (US)
Primary Contact
Investigative Site CA003 (2.6 mi away) Contact
+31 other location

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.

Details
Condition Prurigo Nodularis
Treatment Placebo, INCB054707
Clinical Study IdentifierNCT05061693
SponsorIncyte Corporation
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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