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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

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).

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa; Acne Inversa
• Intervention / Treatment: Drug: INCB054707; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 0B4
      • Investigative Site 101
    • Calgary, Alberta, Canada, T3A 0B2
      • Investigative Site 102
• France
  • Nantes, France, 44093
    • Investigative Site 304
• Germany
  • Berlin, Germany, 10117
    • Investigative Site 403
  • Bochum, Germany, 44791
    • Investigative Site 401
  • Dessau, Germany, 06847
    • Investigative Site 405
  • Dresden, Germany, 01307
    • Investigative Site 406
  • Erlangen, Germany, 91054
    • Investigative Site 404
  • Frankfurt Am Main, Germany, 60590
    • Investigative Site 402
• Poland
  • Rzeszow, Poland, 35-055
    • Investigative Site 552
  • Wroclaw, Poland, 50-566
    • Investigative Site 551
  • Wroclaw, Poland, 51-318
    • Investigative Site 553
• Spain
  • Granada, Spain, 18014
    • Investigative Site 703
  • Madrid, Spain, 28007
    • Investigative Site 702
  • Valencia, Spain, 46940
    • Investigative Site 701
• United States
  • Alabama
    • Hoover, Alabama, United States, 35244
      • Investigative Site 005
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Investigative Site 003
    • Phoenix, Arizona, United States, 85006
      • Investigative Site 011
  • California
    • Fountain Valley, California, United States, 92708
      • Investigative Site 014
    • Fremont, California, United States, 94538
      • Investigative Site 010
    • Huntington Beach, California, United States, 92647
      • Investigative Site 012
    • Newbury Park, California, United States, 91320
      • Investigative Site 022
    • Sacramento, California, United States, 95815
      • Investigative Site 009
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Investigative Site 025
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Investigative Site 015
    • Miami, Florida, United States, 33136
      • Investigative Site 021
    • Tampa, Florida, United States, 33614
      • Investigative Site 006
    • Tampa, Florida, United States, 33624
      • Investigative Site 001
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Investigative Site 016
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Investigative Site 002
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Investigative Site 027
    • New Orleans, Louisiana, United States, 70112
      • Investigative Site 023
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Investigative Site 013
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Investigative Site 004
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Investigative Site 019
  • New York
    • Bronx, New York, United States, 10468
      • Investigative Site 026
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • Investigative Site 008
    • Winston-Salem, North Carolina, United States, 27157
      • Investigative Site 017
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Investigative Site 007
  • Texas
    • Bellaire, Texas, United States, 77401
      • Investigative Site 018

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCB054707 15 mg; 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.	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Experimental: INCB054707 45 mg; 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.	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Experimental: INCB054707 75 mg; 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.	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Placebo Comparator: Placebo followed by INCB054707 75 mg; 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.	Drug: Placebo; Oral; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: INCB 54707-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No