A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

Study Overview
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Brief Summary
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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.

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

Conditions
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Prurigo Nodularis

Intervention / Treatment
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* Drug: INCB054707
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCB054707 Dose A<br>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). | Drug: INCB054707<br>* Oral; Tablet<br>* Other names: Povorcitinib;|
| Experimental: INCB054707 Dose B<br>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). | Drug: INCB054707<br>* Oral; Tablet<br>* Other names: Povorcitinib;|
| Experimental: INCB054707 Dose C<br>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). | Drug: INCB054707<br>* Oral; Tablet<br>* Other names: Povorcitinib;|
| Placebo Comparator: Placebo followed by INCB054707 Dose B or C<br>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). | Drug: Placebo<br>* Oral; Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score | Itch NRS is an 11-point scale (0 to10) where 0 is no itch and 10 is the worst itch imaginable. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving Investigator's Global Assessment Treatment Success (IGA-TS) | Defined as IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline | Week 16 | 
| Time to ≥ 4-point improvement from baseline in Itch NRS score | Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline | Up to Week 48 | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Up to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prurigo nodularis, PN, INCB054707, chronic pruritus