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

Prurigo Nodularis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061693
• Other study ID #: INCB 54707-206
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 28, 2024
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• INCB054707
Oral; Tablet
• Placebo
Oral; Tablet

Locations

Country	Name	City	State
Canada	Investigative Site CA002	Edmonton	Alberta
Canada	Investigative Site CA004	London	Ontario
Canada	Investigative Site CA003	Quebec
Canada	Investigative Site CA001	Surrey	British Columbia
Germany	Investigative Site DE007	Bad Bentheim
Germany	Investigative Site DE005	Berlin
Germany	Investigative Site DE004	Bonn
Germany	Investigative Site DE003	Frankfurt Am Main
Germany	Investigative Site DE001	Hamburg
Germany	Investigative Site DE002	Muenster
Germany	Investigative Site DE008	Tubingen
Poland	Investigative Site PL005	Kielce
Poland	Investigative Site PL003	Osielsko
Poland	Investigative Site PL001	Rzeszow
Poland	Investigative Site PL004	Torun
Poland	Investigative Site PL002	Wroclaw
Puerto Rico	Investigative Site PR002	Caguas
Puerto Rico	Investigative Site PR001	San Juan
Spain	Investigative Site ES004	Alicante
Spain	Investigative Site ES007	Badalona
Spain	Investigative Site ES001	Barcelona
Spain	Investigative Site ES002	Cordoba
Spain	Investigative Site ES006	Granada
Spain	Investigative Site ES003	Madrid
Spain	Investigative Site ES008	Madrid
Spain	Investigative Site ES005	Valencia
United States	Investigative Site US021	Arlington	Texas
United States	Investigative Site US023	Athens	Ohio
United States	Investigative Site US005	Austin	Texas
United States	Investigative Site US003	Baltimore	Maryland
United States	Investigative Site US018	Dallas	Texas
United States	Investigative Site US002	Dublin	Ohio
United States	Investigative Site US019	Fort Lauderdale	Florida
United States	Investigative Site US001	Fountain Valley	California
United States	Investigative Site US012	Gahanna	Ohio
United States	Investigative Site US007	Houston	Texas
United States	Investigative Site US016	Miami	Florida
United States	Investigative Site US013	Miramar	Florida
United States	Investigative Site US022	Murfreesboro	Tennessee
United States	Investigative Site 1071320	Newnan	Georgia
United States	Investigative Site US010	Phoenix	Arizona
United States	Investigative Site US024	Phoenix	Arizona
United States	Investigative Site US008	Plainfield	Indiana
United States	Investigative Site US004	Portsmouth	New Hampshire
United States	Investigative Site US014	Sacramento	California
United States	Investigative Site US006	Saint Joseph	Missouri
United States	Investigative Site US011	South Bend	Indiana
United States	Investigative Site US009	Tampa	Florida
United States	Investigative Site US017	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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