A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis (NCT05061693) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
United States146 participantsStarted 2021-11-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16