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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476043
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Acne Inversa Drug: INCB054707 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : July 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INCB054707 Dose A
Participants will receive INCB054707 Dose A for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
Drug: INCB054707
Oral; Tablet

Experimental: INCB054707 Dose B
Participants will receive INCB054707 Dose B for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
Drug: INCB054707
Oral; Tablet

Experimental: INCB054707 Dose C
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2)
Drug: INCB054707
Oral; Tablet

Placebo Comparator: Placebo followed by INCB054707 Dose C
Participants will receive placebo for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2).
Drug: Placebo
Oral; Tablet




Primary Outcome Measures :
  1. Mean change in total AN count [ Time Frame: Week 16 ]
    Defined as mean change of Abscess and Inflammatory Nodule (AN) count relative to baseline.


Secondary Outcome Measures :
  1. Proportion of participants who achieve HiSCR [ Time Frame: Week 16 ]
    HiSCR defined as at least a 50% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

  2. Proportion of participants who achieve HiSCR at each visit [ Time Frame: Weeks 2 to 12 ]
    HiSCR defined as at least a 50% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

  3. Proportion of participants who achieve HSCR75 at each visit [ Time Frame: Weeks 2 to 16 ]
    HiSCR75 defined as at least a 75% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

  4. Mean change in IHS4 at each visit [ Time Frame: Weeks 2 to 16 ]
    Defined as change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4).

  5. Proportion of participants achieving AN50, AN75, AN90, and AN100 at each visit [ Time Frame: Weeks 2 to 16 ]
    Defined as reduction in AN count by at least 50%, 75%, 90% and 100% relative to baseline.

  6. Mean change in AN count relative to baseline at each visit [ Time Frame: Weeks 2 to 12 ]
    Defined as mean change of Abscess and Inflammatory Nodule (AN) count relative to baseline.

  7. Proportion of participants achieving AN of 0 to 2 at each visit [ Time Frame: Weeks 2 to 16 ]
    Defined as Abscess and Inflammatory Nodule (AN) count.

  8. Mean change from baseline in the draining fistula count at each visit [ Time Frame: Weeks 2 to 16 ]
    Defined as the mean change from baseline in the draining fistulas count at each visit.

  9. Mean change in ANF count at each visit [ Time Frame: Weeks 2 to 16 ]
    Defined as the mean change from baseline in the sum of abscess, inflammatory nodule, and draining fistula count.

  10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 56 weeks ]
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476043


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, Alabama
Investigative Site 005 Recruiting
Hoover, Alabama, United States, 35244
United States, Arizona
Investigative Site 003 Recruiting
Gilbert, Arizona, United States, 85295
United States, California
Investigative Site 014 Recruiting
Fountain Valley, California, United States, 92708
Investigative Site 012 Recruiting
Huntington Beach, California, United States, 92647
Investigative Site 009 Recruiting
Sacramento, California, United States, 95815
United States, Florida
Investigative Site 006 Recruiting
Tampa, Florida, United States, 33614
Investigative Site 001 Recruiting
Tampa, Florida, United States, 33624
United States, Indiana
Investigative Site 002 Recruiting
West Lafayette, Indiana, United States, 47906
United States, Michigan
Investigative Site 004 Recruiting
Fort Gratiot, Michigan, United States, 48059
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04476043    
Other Study ID Numbers: INCB 54707-204
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration