Clinical trial NCT04476043: To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Acne Inversa
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).


Eligibility criteria: Inclusion Criteria:

* HS disease duration of at least 3 months before screening.
* Willingness to avoid pregnancy or fathering children.
* Active HS in at least 2 distinct anatomical areas.
* Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

Exclusion Criteria:

* Draining fistula count of \> 20 at screening or baseline.
* 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.
* History of failure to treatment of inflammatory diseases with JAK inhibitors.
* 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.

Primary outcomes:
measure: Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Baseline; Week 16
measure: Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
timeFrame: Baseline; Weeks 2, 4, 6, 8, and 12
measure: Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
timeFrame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
measure: Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16
timeFrame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
measure: Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
timeFrame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
measure: Mean Change From Baseline in AN Count at Weeks 2 to 12
timeFrame: Baseline; Weeks 2, 4, 6, 8, and 12
measure: Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
timeFrame: Weeks 2, 4, 6, 8, 12, and 16
measure: Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
timeFrame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
measure: Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
timeFrame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to Week 16
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Investigative Site 005
state: Alabama
city: Gilbert
country: United States
facility: Investigative Site 003
state: Arizona
city: Phoenix
country: United States
facility: Investigative Site 011
state: Arizona
city: Fountain Valley
country: United States
facility: Investigative Site 014
state: California
city: Fremont
country: United States
facility: Investigative Site 010
state: California
city: Huntington Beach
country: United States
facility: Investigative Site 012
state: California
city: Newbury Park
country: United States
facility: Investigative Site 022
state: California
city: Sacramento
country: United States
facility: Investigative Site 009
state: California
city: Cromwell
country: United States
facility: Investigative Site 025
state: Connecticut
city: Coral Gables
country: United States
facility: Investigative Site 015
state: Florida
city: Miami
country: United States
facility: Investigative Site 021
state: Florida
city: Tampa
country: United States
facility: Investigative Site 006
state: Florida
city: Tampa
country: United States
facility: Investigative Site 001
state: Florida
city: Atlanta
country: United States
facility: Investigative Site 016
state: Georgia
city: West Lafayette
country: United States
facility: Investigative Site 002
state: Indiana
city: Baton Rouge
country: United States
facility: Investigative Site 027
state: Louisiana
city: New Orleans
country: United States
facility: Investigative Site 023
state: Louisiana
city: Boston
country: United States
facility: Investigative Site 013
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Investigative Site 004
state: Michigan
city: Saint Louis
country: United States
facility: Investigative Site 019
state: Missouri
city: Bronx
country: United States
facility: Investigative Site 026
state: New York
city: Chapel Hill
country: United States
facility: Investigative Site 008
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigative Site 017
state: North Carolina
city: Hershey
country: United States
facility: Investigative Site 007
state: Pennsylvania
city: Bellaire
country: United States
facility: Investigative Site 018
state: Texas
city: Calgary
country: Canada
facility: Investigative Site 101
state: Alberta
city: Calgary
country: Canada
facility: Investigative Site 102
state: Alberta
city: Nantes
country: France
facility: Investigative Site 304
city: Berlin
country: Germany
facility: Investigative Site 403
city: Bochum
country: Germany
facility: Investigative Site 401
city: Dessau
country: Germany
facility: Investigative Site 405
city: Dresden
country: Germany
facility: Investigative Site 406
city: Erlangen
country: Germany
facility: Investigative Site 404
city: Frankfurt Am Main
country: Germany
facility: Investigative Site 402
city: Rzeszow
country: Poland
facility: Investigative Site 552
city: Wroclaw
country: Poland
facility: Investigative Site 551
city: Wroclaw
country: Poland
facility: Investigative Site 553
city: Granada
country: Spain
facility: Investigative Site 703
city: Madrid
country: Spain
facility: Investigative Site 702
city: Valencia
country: Spain
facility: Investigative Site 701
Study officials:
References: