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

Primary Purpose

Hidradenitis Suppurativa, Acne Inversa

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB054707
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site 005
  • Investigative Site 003
  • Investigative Site 011
  • Investigative Site 014
  • Investigative Site 010
  • Investigative Site 012
  • Investigative Site 022
  • Investigative Site 009
  • Investigative Site 025
  • Investigative Site 015
  • Investigative Site 021
  • Investigative Site 006
  • Investigative Site 001
  • Investigative Site 016
  • Investigative Site 002
  • Investigative Site 027
  • Investigative Site 023
  • Investigative Site 013
  • Investigative Site 004
  • Investigative Site 019
  • Investigative Site 026
  • Investigative Site 008
  • Investigative Site 017
  • Investigative Site 007
  • Investigative Site 018
  • Investigative Site 101
  • Investigative Site 102
  • Investigative Site 304
  • Investigative Site 403
  • Investigative Site 401
  • Investigative Site 405
  • Investigative Site 406
  • Investigative Site 404
  • Investigative Site 402
  • Investigative Site 552
  • Investigative Site 551
  • Investigative Site 553
  • Investigative Site 703
  • Investigative Site 702
  • Investigative Site 701

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

INCB054707 15 mg

INCB054707 45 mg

INCB054707 75 mg

Placebo followed by INCB054707 75 mg

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 15, 2020
Last Updated
September 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04476043
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Acne Inversa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCB054707 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
INCB054707 45 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
INCB054707 75 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo followed by INCB054707 75 mg
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INCB054707
Other Intervention Name(s)
Povorcitinib
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Description
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.
Time Frame
Baseline; Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Description
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.
Time Frame
Baseline; Week 16
Title
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Description
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.
Time Frame
Baseline; Weeks 2, 4, 6, 8, and 12
Title
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Description
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.
Time Frame
Baseline; Weeks 2, 4, 6, 8, 12, and 16
Title
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
Description
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.
Time Frame
Baseline; Weeks 2, 4, 6, 8, 12, and 16
Title
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
Description
AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.
Time Frame
Baseline; Weeks 2, 4, 6, 8, 12, and 16
Title
Mean Change From Baseline in AN Count at Weeks 2 to 12
Description
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.
Time Frame
Baseline; Weeks 2, 4, 6, 8, and 12
Title
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Description
Total AN count was assessed throughout the study.
Time Frame
Weeks 2, 4, 6, 8, 12, and 16
Title
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame
Baseline; Weeks 2, 4, 6, 8, 12, and 16
Title
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Description
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.
Time Frame
Baseline; Weeks 2, 4, 6, 8, 12, and 16
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Investigative Site 005
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Investigative Site 003
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Investigative Site 011
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Investigative Site 014
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigative Site 010
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Investigative Site 012
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Investigative Site 022
City
Newbury Park
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Investigative Site 009
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Investigative Site 025
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Investigative Site 015
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigative Site 021
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigative Site 006
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigative Site 001
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Investigative Site 016
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Investigative Site 002
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Facility Name
Investigative Site 027
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Investigative Site 023
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Investigative Site 013
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Investigative Site 004
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Investigative Site 019
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigative Site 026
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Investigative Site 008
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Investigative Site 017
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Investigative Site 007
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Investigative Site 018
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Investigative Site 101
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 0B4
Country
Canada
Facility Name
Investigative Site 102
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 0B2
Country
Canada
Facility Name
Investigative Site 304
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigative Site 403
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigative Site 401
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigative Site 405
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Investigative Site 406
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigative Site 404
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Investigative Site 402
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigative Site 552
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Investigative Site 551
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Investigative Site 553
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Investigative Site 703
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Investigative Site 702
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigative Site 701
City
Valencia
ZIP/Postal Code
46940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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