Phase 2
N=146
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Prurigo Nodularis
Bottom Line
View on ClinicalTrials.gov: NCT05061693 ↗Enrolled (actual)
146
Serious AEs
6.3%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 — 8.1; 36.1; 44.4; 56.8 percentage of participants — p=0.0061
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCB054707 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 |
8.1; 36.1; 44.4; 56.8 | 0.0061 sig |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 |
5.4; 13.9; 30.6; 48.6 | — |
| SECONDARY Time to ≥4-point Improvement From Baseline in Itch NRS Score |
NA; 58.0; 35.0; 19.0 | — |
| SECONDARY PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
20; 20; 25; 28 | — |
| SECONDARY PC Period: Number of Participants With Any ≥Grade 3 TEAE |
0; 1; 1; 2 | — |
| SECONDARY Extension Period: Number of Participants With Any TEAE |
0; 3; 5; 7; 20; 19 | — |
| SECONDARY Extension Period: Number of Participants With Any ≥Grade 3 TEAE |
0; 0; 0; 1; 0; 1 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT05061693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.