To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

Hidradenitis Suppurativa 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 Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476043
• Other study ID #: INCB 54707-204
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Acne Inversa
• Hidradenitis
• Hidradenitis Suppurativa

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