A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Prurigo Nodularis
About this trial
This is an interventional treatment trial for Prurigo Nodularis focused on measuring Prurigo nodularis, PN, INCB054707, chronic pruritus
Eligibility 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 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.
Sites / Locations
- Investigative Site US010
- Investigative Site US024
- Investigative Site US001
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- Investigative Site 1071320
- Investigative Site US008
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- Investigative Site US006
- Investigative Site US004
- Investigative Site US023
- Investigative Site US002
- Investigative Site US012
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- Investigative Site US021
- Investigative Site US005
- Investigative Site US018
- Investigative Site US007
- Investigative Site CA002
- Investigative Site CA001
- Investigative Site CA004
- Investigative Site CA003
- Investigative Site DE007
- Investigative Site DE005
- Investigative Site DE004
- Investigative Site DE003
- Investigative Site DE001
- Investigative Site DE002
- Investigative Site DE008
- Investigative Site PL005
- Investigative Site PL003
- Investigative Site PL001
- Investigative Site PL004
- Investigative Site PL002
- Investigative Site PR002
- Investigative Site PR001
- Investigative Site ES004
- Investigative Site ES007
- Investigative Site ES001
- Investigative Site ES002
- Investigative Site ES006
- Investigative Site ES008
- Investigative Site ES003
- Investigative Site ES005
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
INCB054707 Dose A
INCB054707 Dose B
INCB054707 Dose C
Placebo followed by INCB054707 Dose B or C
Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).