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

Phase 2

Completed

• Conditions: Prurigo Nodularis
• Interventions: Drug: INCB054707; Drug: Placebo

• Registration Number: NCT05061693
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-29
• Study Start: 2021-11-04
• Primary Completion: 2023-08-11
• Study Completion: 2024-02-28
• Status Verified: 2024-08
• Results First Submitted: 2024-08-02
• Results First Submitted QC: 2024-08-02
• Results First Posted: 2024-08-27
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INCB054707 Dose B	INCB054707	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).
Placebo followed by INCB054707 Dose B or C	Placebo	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).
INCB054707 Dose A	INCB054707	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).
INCB054707 Dose C	INCB054707	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16	Baseline; Week 16	Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.

Trial Locations

Locations (49)

Investigative Site US016; 🇺🇸 Miami, Florida, United States

Investigative Site PL004; 🇵🇱 Torun, Poland

Investigative Site US010; 🇺🇸 Phoenix, Arizona, United States

Investigative Site US019; 🇺🇸 Fort Lauderdale, Florida, United States

Investigative Site DE007; 🇩🇪 Bad Bentheim, Germany

Investigative Site DE004; 🇩🇪 Bonn, Germany

Investigative Site CA001; 🇨🇦 Surrey, British Columbia, Canada

Investigative Site US017; 🇺🇸 Troy, Michigan, United States

Investigative Site CA004; 🇨🇦 London, Ontario, Canada

Investigative Site US003; 🇺🇸 Baltimore, Maryland, United States

Investigative Site US004; 🇺🇸 Portsmouth, New Hampshire, United States

Investigative Site US024; 🇺🇸 Phoenix, Arizona, United States

Investigative Site PL003; 🇵🇱 Osielsko, Poland

Investigative Site DE005; 🇩🇪 Berlin, Germany

Investigative Site CA003; 🇨🇦 Quebec, Canada

Investigative Site DE008; 🇩🇪 Tubingen, Germany

Investigative Site CA002; 🇨🇦 Edmonton, Alberta, Canada

Investigative Site PL005; 🇵🇱 Kielce, Poland

Investigative Site PL001; 🇵🇱 Rzeszow, Poland

Investigative Site PL002; 🇵🇱 Wroclaw, Poland

Investigative Site PR002; 🇵🇷 Caguas, Puerto Rico

Investigative Site PR001; 🇵🇷 San Juan, Puerto Rico

Investigative Site DE002; 🇩🇪 Muenster, Germany

Investigative Site US009; 🇺🇸 Tampa, Florida, United States

Investigative Site ES002; 🇪🇸 Cordoba, Spain

Investigative Site ES005; 🇪🇸 Valencia, Spain

Investigative Site US001; 🇺🇸 Fountain Valley, California, United States

Investigative Site US013; 🇺🇸 Miramar, Florida, United States

Investigative Site 1071320; 🇺🇸 Newnan, Georgia, United States

Investigative Site US008; 🇺🇸 Plainfield, Indiana, United States

Investigative Site US011; 🇺🇸 South Bend, Indiana, United States

Investigative Site US006; 🇺🇸 Saint Joseph, Missouri, United States

Investigative Site US002; 🇺🇸 Dublin, Ohio, United States

Investigative Site US023; 🇺🇸 Athens, Ohio, United States

Investigative Site US012; 🇺🇸 Gahanna, Ohio, United States

Investigative Site US022; 🇺🇸 Murfreesboro, Tennessee, United States

Investigative Site US021; 🇺🇸 Arlington, Texas, United States

Investigative Site US018; 🇺🇸 Dallas, Texas, United States

Investigative Site US007; 🇺🇸 Houston, Texas, United States

Investigative Site ES001; 🇪🇸 Barcelona, Spain

Investigative Site DE003; 🇩🇪 Frankfurt Am Main, Germany

Investigative Site DE001; 🇩🇪 Hamburg, Germany

Investigative Site ES004; 🇪🇸 Alicante, Spain

Investigative Site ES007; 🇪🇸 Badalona, Spain

Investigative Site ES006; 🇪🇸 Granada, Spain

Investigative Site ES003; 🇪🇸 Madrid, Spain

Investigative Site ES008; 🇪🇸 Madrid, Spain

Investigative Site US014; 🇺🇸 Sacramento, California, United States

Investigative Site US005; 🇺🇸 Austin, Texas, United States