To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
- Conditions
- Hidradenitis SuppurativaAcne Inversa
- Interventions
- Drug: Placebo
- Registration Number
- NCT04476043
- Lead Sponsor
- Incyte Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INCB054707 15 mg INCB054707 Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. INCB054707 45 mg INCB054707 Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. INCB054707 75 mg INCB054707 Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks. Placebo followed by INCB054707 75 mg Placebo Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 Baseline; 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 Baseline; 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.
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 Baseline; Weeks 2, 4, 6, 8, and 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.
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 Baseline; Weeks 2, 4, 6, 8, 12, and 16 AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.
Mean Change From Baseline in AN Count at Weeks 2 to 12 Baseline; Weeks 2, 4, 6, 8, and 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.
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 Baseline; Weeks 2, 4, 6, 8, 12, and 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.
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 Baseline; Weeks 2, 4, 6, 8, 12, and 16 Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 Baseline; Weeks 2, 4, 6, 8, 12, and 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.
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 Baseline; Weeks 2, 4, 6, 8, 12, and 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.
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 Weeks 2, 4, 6, 8, 12, and 16 Total AN count was assessed throughout the study.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to Week 16 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.
Trial Locations
- Locations (40)
Investigative Site 018
🇺🇸Bellaire, Texas, United States
Investigative Site 403
🇩🇪Berlin, Germany
Investigative Site 401
🇩🇪Bochum, Germany
Investigative Site 405
🇩🇪Dessau, Germany
Investigative Site 003
🇺🇸Gilbert, Arizona, United States
Investigative Site 005
🇺🇸Hoover, Alabama, United States
Investigative Site 014
🇺🇸Fountain Valley, California, United States
Investigative Site 012
🇺🇸Huntington Beach, California, United States
Investigative Site 016
🇺🇸Atlanta, Georgia, United States
Investigative Site 025
🇺🇸Cromwell, Connecticut, United States
Investigative Site 015
🇺🇸Coral Gables, Florida, United States
Investigative Site 101
🇨🇦Calgary, Alberta, Canada
Investigative Site 027
🇺🇸Baton Rouge, Louisiana, United States
Investigative Site 004
🇺🇸Fort Gratiot, Michigan, United States
Investigative Site 019
🇺🇸Saint Louis, Missouri, United States
Investigative Site 026
🇺🇸Bronx, New York, United States
Investigative Site 102
🇨🇦Calgary, Alberta, Canada
Investigative Site 304
🇫🇷Nantes, France
Investigative Site 007
🇺🇸Hershey, Pennsylvania, United States
Investigative Site 404
🇩🇪Erlangen, Germany
Investigative Site 552
🇵🇱Rzeszow, Poland
Investigative Site 551
🇵🇱Wroclaw, Poland
Investigative Site 553
🇵🇱Wroclaw, Poland
Investigative Site 703
🇪🇸Granada, Spain
Investigative Site 702
🇪🇸Madrid, Spain
Investigative Site 701
🇪🇸Valencia, Spain
Investigative Site 013
🇺🇸Boston, Massachusetts, United States
Investigative Site 010
🇺🇸Fremont, California, United States
Investigative Site 022
🇺🇸Newbury Park, California, United States
Investigative Site 002
🇺🇸West Lafayette, Indiana, United States
Investigative Site 402
🇩🇪Frankfurt Am Main, Germany
Investigative Site 406
🇩🇪Dresden, Germany
Investigative Site 011
🇺🇸Phoenix, Arizona, United States
Investigative Site 009
🇺🇸Sacramento, California, United States
Investigative Site 021
🇺🇸Miami, Florida, United States
Investigative Site 006
🇺🇸Tampa, Florida, United States
Investigative Site 001
🇺🇸Tampa, Florida, United States
Investigative Site 017
🇺🇸Winston-Salem, North Carolina, United States
Investigative Site 023
🇺🇸New Orleans, Louisiana, United States
Investigative Site 008
🇺🇸Chapel Hill, North Carolina, United States