Clinical trial NCT05061693: A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prurigo Nodularis
Keywords: Prurigo nodularis
PN
INCB054707
chronic pruritus
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: 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
timeFrame: Baseline; Week 16
measure: Time to ≥4-point Improvement From Baseline in Itch NRS Score
timeFrame: up to 122 days
measure: PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 152 days
measure: PC Period: Number of Participants With Any ≥Grade 3 TEAE
timeFrame: up to 152 days
measure: Extension Period: Number of Participants With Any TEAE
timeFrame: up to 215 days
measure: Extension Period: Number of Participants With Any ≥Grade 3 TEAE
timeFrame: up to 215 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site US010
state: Arizona
city: Phoenix
country: United States
facility: Investigative Site US024
state: Arizona
city: Fountain Valley
country: United States
facility: Investigative Site US001
state: California
city: Sacramento
country: United States
facility: Investigative Site US014
state: California
city: Fort Lauderdale
country: United States
facility: Investigative Site US019
state: Florida
city: Miami
country: United States
facility: Investigative Site US016
state: Florida
city: Miramar
country: United States
facility: Investigative Site US013
state: Florida
city: Tampa
country: United States
facility: Investigative Site US009
state: Florida
city: Newnan
country: United States
facility: Investigative Site 1071320
state: Georgia
city: Plainfield
country: United States
facility: Investigative Site US008
state: Indiana
city: South Bend
country: United States
facility: Investigative Site US011
state: Indiana
city: Baltimore
country: United States
facility: Investigative Site US003
state: Maryland
city: Troy
country: United States
facility: Investigative Site US017
state: Michigan
city: Saint Joseph
country: United States
facility: Investigative Site US006
state: Missouri
city: Portsmouth
country: United States
facility: Investigative Site US004
state: New Hampshire
city: Athens
country: United States
facility: Investigative Site US023
state: Ohio
city: Dublin
country: United States
facility: Investigative Site US002
state: Ohio
city: Gahanna
country: United States
facility: Investigative Site US012
state: Ohio
city: Murfreesboro
country: United States
facility: Investigative Site US022
state: Tennessee
city: Arlington
country: United States
facility: Investigative Site US021
state: Texas
city: Austin
country: United States
facility: Investigative Site US005
state: Texas
city: Dallas
country: United States
facility: Investigative Site US018
state: Texas
city: Houston
country: United States
facility: Investigative Site US007
state: Texas
city: Edmonton
country: Canada
facility: Investigative Site CA002
state: Alberta
city: Surrey
country: Canada
facility: Investigative Site CA001
state: British Columbia
city: London
country: Canada
facility: Investigative Site CA004
state: Ontario
city: Quebec
country: Canada
facility: Investigative Site CA003
city: Bad Bentheim
country: Germany
facility: Investigative Site DE007
city: Berlin
country: Germany
facility: Investigative Site DE005
city: Bonn
country: Germany
facility: Investigative Site DE004
city: Frankfurt Am Main
country: Germany
facility: Investigative Site DE003
city: Hamburg
country: Germany
facility: Investigative Site DE001
city: Muenster
country: Germany
facility: Investigative Site DE002
city: Tubingen
country: Germany
facility: Investigative Site DE008
city: Kielce
country: Poland
facility: Investigative Site PL005
city: Osielsko
country: Poland
facility: Investigative Site PL003
city: Rzeszow
country: Poland
facility: Investigative Site PL001
city: Torun
country: Poland
facility: Investigative Site PL004
city: Wroclaw
country: Poland
facility: Investigative Site PL002
city: Caguas
country: Puerto Rico
facility: Investigative Site PR002
city: San Juan
country: Puerto Rico
facility: Investigative Site PR001
city: Alicante
country: Spain
facility: Investigative Site ES004
city: Badalona
country: Spain
facility: Investigative Site ES007
city: Barcelona
country: Spain
facility: Investigative Site ES001
city: Cordoba
country: Spain
facility: Investigative Site ES002
city: Granada
country: Spain
facility: Investigative Site ES006
city: Madrid
country: Spain
facility: Investigative Site ES008
city: Madrid
country: Spain
facility: Investigative Site ES003
city: Valencia
country: Spain
facility: Investigative Site ES005
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References: