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A Study of the 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03569371
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INCB054707 Drug: INCB054707
INCB054707 administered once daily orally with water without regard to food for 8 weeks.




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 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.


Secondary Outcome Measures :
  1. Apparent oral clearance of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    To evaluate the systemic exposure to INCB054707.

  2. Apparent oral volume of distribution of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    To evaluate the systemic exposure to INCB054707.

  3. Absorption constant of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

  4. Apparent inter-compartmental clearance [ Time Frame: Up to approximately 6 weeks. ]
    Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.

  5. Proportion of participants with a hidradenitis suppurativa clinical response (HiSCR) at each visit [ Time Frame: Up to approximately 12 weeks. ]
    An HiSCR is defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline at each visit.

  6. Proportion of participants achieving an AN count of 0 to 2 at each visit [ Time Frame: Up to approximately 12 weeks. ]
    Abscess and inflammatory nodule count.

  7. Mean change from baseline in the HS Pain Numeric Rating Scale (NRS) scores at each visit [ Time Frame: Up to approximately 12 weeks. ]
    The HS Pain NRS is an 11-point scale used to assess the worst skin pain and the average skin pain due to HS.

  8. Mean change from baseline in the modified Sartorius scale score [ Time Frame: Week 8. ]
    The modified Sartorius scale is a measure of the severity of HS with points given for each body area. The total modified Sartorius scale score is the sum of the 12 anatomic region scores.

  9. Mean change from baseline in the number of draining fistulas count at each visit [ Time Frame: Up to approximately 12 weeks. ]
    Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

  10. Proportion of participants at each category of Hurley Stage [ Time Frame: Baseline and Week 8. ]
    Investigator-determined Hurley Stage (I, II, or III, corresponding with the Hurley Stage of worst involved anatomic region).

  11. Proportion of participants with change from baseline in Hurley Stage [ Time Frame: Week 8. ]
    Investigator-determined Hurley Stage (I, II, or III, corresponding with the Hurley Stage of worst involved anatomic region).

  12. Proportions of participants in each HS Patient Global Impression of Change (PGIC) category [ Time Frame: Up to approximately 12 weeks. ]
    The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area.

  13. Proportion of participants requiring rescue lesional treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.

  14. Number of interventions with rescue lesional treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.

  15. Proportion of participants at each scoring category of the Dermatology Life Quality Index (DLQI) at each visit [ Time Frame: Up to approximately 12 weeks. ]
    The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life.



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:

  • Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
  • Stable course of HS for at least 90 days before screening, as determined by the investigator.
  • HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or III at screening and baseline.
  • Total AN count of at least 3 at screening and baseline.
  • Male participants must agree to use contraception per protocol-defined criteria.

Exclusion Criteria:

  • Women of childbearing potential or who are currently pregnant or lactating.
  • Presence of > 20 draining fistulas at screening and baseline.
  • Participants with concurrent conditions or history of other diseases as follows:

    • Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
    • Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
    • Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
    • Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
    • History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
    • Albinism.
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
  • Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
  • Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
  • Decreased blood cell counts at screening as per protocol-defined parameters.
  • Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
  • Impaired renal function with serum creatinine > 1.5 mg/dL.
  • Use of prohibited medications per protocol-defined criteria.
  • Known or suspected allergy to INCB054707 or any component of the study drug.
  • Known history of clinically significant drug or alcohol abuse in the last year prior to baseline.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

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): NCT03569371


Locations
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United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Florida
Forward Clinical Trials, Inc.
Tampa, Florida, United States, 33624
United States, New York
Rockefeller University
New York, New York, United States, 10065
United States, Pennsylvania
Penn State Hershey Dermatology
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03569371     History of Changes
Other Study ID Numbers: INCB 54707-202
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Hidradenitis suppurativa (HS)
Janus kinase (JAK)
Janus kinase 1 (JAK1) inhibitor

Additional relevant MeSH terms:
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Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration