A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
About the study
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 take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Prurigo Nodularis
Age (in years)
18+
Phase
Phase 2
Participants needed
146
Est. Completion Date
Apr 14, 2024
Treatment type
Interventional
Sponsor
Incyte Corporation
ClinicalTrials.gov identifier
NCT05061693
Study number
INCB 54707-206
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