Study Description
Brief 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.
Condition or Disease
Prurigo Nodularis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis |
| Actual Study Start Date: | November 4, 2021 |
| Estimated Primary Completion Date: | April 20, 2023 |
| Estimated Study Completion Date: | November 2, 2023 |
Outcome Measures
Primary Outcome Measures
- Proportion of participants achieving ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score [ Time Frame: Week 16 ]
Itch NRS is an 11-point scale (0 to10) where 0 is “no itch” and 10 is the “worst itch imaginable”.
Secondary Outcome Measures
- Proportion of participants achieving Investigator’s Global Assessment Treatment Success (IGA-TS) [ Time Frame: Week 16 ]
Defined as IGA score of 0 or 1 with a ≥ 2-grade improvement from baseline
- Time to ≥ 4-point improvement from baseline in Itch NRS score [ Time Frame: Up to Week 48 ]
Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]
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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.