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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04476043
Other study ID # INCB 54707-204
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 25, 2020
Est. completion date August 16, 2023

Study information

Verified date September 2023
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date August 16, 2023
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INCB054707
Oral; Tablet
Placebo
Oral; Tablet

Locations

Country Name City State
Canada Investigative Site 101 Calgary Alberta
Canada Investigative Site 102 Calgary Alberta
France Investigative Site 304 Nantes
Germany Investigative Site 403 Berlin
Germany Investigative Site 401 Bochum
Germany Investigative Site 405 Dessau
Germany Investigative Site 406 Dresden
Germany Investigative Site 404 Erlangen
Germany Investigative Site 402 Frankfurt Am Main
Poland Investigative Site 552 Rzeszow
Poland Investigative Site 551 Wroclaw
Poland Investigative Site 553 Wroclaw
Spain Investigative Site 703 Granada
Spain Investigative Site 702 Madrid
Spain Investigative Site 701 Valencia
United States Investigative Site 016 Atlanta Georgia
United States Investigative Site 027 Baton Rouge Louisiana
United States Investigative Site 018 Bellaire Texas
United States Investigative Site 013 Boston Massachusetts
United States Investigative Site 026 Bronx New York
United States Investigative Site 008 Chapel Hill North Carolina
United States Investigative Site 015 Coral Gables Florida
United States Investigative Site 025 Cromwell Connecticut
United States Investigative Site 004 Fort Gratiot Michigan
United States Investigative Site 014 Fountain Valley California
United States Investigative Site 010 Fremont California
United States Investigative Site 003 Gilbert Arizona
United States Investigative Site 007 Hershey Pennsylvania
United States Investigative Site 005 Hoover Alabama
United States Investigative Site 012 Huntington Beach California
United States Investigative Site 021 Miami Florida
United States Investigative Site 023 New Orleans Louisiana
United States Investigative Site 022 Newbury Park California
United States Investigative Site 011 Phoenix Arizona
United States Investigative Site 009 Sacramento California
United States Investigative Site 019 Saint Louis Missouri
United States Investigative Site 001 Tampa Florida
United States Investigative Site 006 Tampa Florida
United States Investigative Site 002 West Lafayette Indiana
United States Investigative Site 017 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. Baseline; Week 16
Secondary Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. Baseline; Week 16
Secondary Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. Baseline; Weeks 2, 4, 6, 8, and 12
Secondary Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. Baseline; Weeks 2, 4, 6, 8, 12, and 16
Secondary 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 Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe =11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. Baseline; Weeks 2, 4, 6, 8, 12, and 16
Secondary Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count. Baseline; Weeks 2, 4, 6, 8, 12, and 16
Secondary Mean Change From Baseline in AN Count at Weeks 2 to 12 Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. Baseline; Weeks 2, 4, 6, 8, and 12
Secondary Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 Total AN count was assessed throughout the study. Weeks 2, 4, 6, 8, 12, and 16
Secondary Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline; Weeks 2, 4, 6, 8, 12, and 16
Secondary Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. Baseline; Weeks 2, 4, 6, 8, 12, and 16
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. up to Week 16
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