Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Placebo-Controlled 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: NCT03607487
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
INCB054707 at the Cohort 1 dose or placebo.
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.

Drug: Placebo
Placebo tablet administered orally once daily.

Experimental: Cohort 2
INCB054707 at the Cohort 2 dose or placebo.
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.

Drug: Placebo
Placebo tablet administered orally once daily.

Experimental: Cohort 3
INCB054707 at the Cohort 3 dose or placebo.
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.

Drug: Placebo
Placebo tablet administered orally once daily.




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 8 weeks ]
    TEAE is defined as any adverse event 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 Week 8 ]
    To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.

  2. Apparent oral volume of distribution of INCB054707 [ Time Frame: Up to Week 8 ]
    To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.

  3. Proportion of participants achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at each visit [ Time Frame: From screening up to 16 weeks ]
    HiSCR 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.

  4. Proportion of participants achieving an AN count of 0 to 2 at each visit [ Time Frame: Up to 16 weeks ]
    AN defined as abscess and inflammatory nodule count.

  5. Mean change from baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) scores at each visit [ Time Frame: From baseline up to 12 weeks ]
    An 11-point scale used to assess the worst skin pain and the average skin pain due to HS.

  6. Mean change from baseline in the modified Sartorius scale score [ Time Frame: From baseline up to week 8 ]
    Scale measuring the severity of HS.

  7. Mean change from baseline in the number of draining fistulas count at each visit. [ Time Frame: From baseline up to 16 weeks ]
    Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

  8. Proportion of participants at each category of Hurley Stage [ Time Frame: Baseline and Week 8 ]
    Investigator-determined Hurley Stage (I, II, or III) of HS.

  9. Proportion of participants with change from baseline in Hurley Stage [ Time Frame: From baseline to Week 8 ]
    Proportion of participants at each category of Hurley Stage.

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

  11. Actual measurements in HS-PGIC at each visit [ Time Frame: Up to 12 weeks ]
    Participant self-administered 1-item questionnaire that assesses change in the severity of skin in the HS area.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 Hurley Stage III at screening.
  • Total AN count of at least 3 at screening and baseline.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Women who are currently pregnant or lactating.
  • Presence of > 20 draining fistulas at screening and baseline.
  • Participants with protocol-defined concurrent conditions or history of other diseases.
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
  • Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
  • A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
  • Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
  • Decreased blood cell counts at screening per protocol-defined criteria.
  • Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
  • Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
  • Use of protocol-prohibited medications.
  • 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 before baseline.

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): NCT03607487


Locations
Layout table for location information
Canada, Manitoba
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, New Brunswick
Brunswick Dermatology Center
Fredericton, New Brunswick, Canada, E3B 1G9
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada, L4M 7G1
DermEffects
London, Ontario, Canada, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7
Windsor Clinical Research, Inc
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Dr Isabelle Delorme Inc.
Drummondville, Quebec, Canada, J2B 5L4
Dre Angelique Gagne-Henley MD inc.
St-Jerome, Quebec, Canada, J7Z 7E2
Denmark
Aarhus University hospital Afdeling for hud- og kønssygdomme
Aarhus, Denmark, 8200
Sjællands universitetshospital, Roskilde Dermatologisk afdeling
Roskilde, Denmark, 4000
Germany
Universitätsklinikum Münster Abteilung für Dermatologie
Münster, North Rhine-Westphalia, Germany, 48149
Ruhr-Universität Bochum Dermatologische Studienambulanz Haus J, 1. Etage
Bochum, Noth Rhine-Westphalia, Germany, 44791
Universitätsklinikum Schleswig-Holstein Institut für Entzündungsmedizin
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: Kathleen Butler, MD Incyte Corporation

Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03607487    
Other Study ID Numbers: INCB 54707-203
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Incyte Corporation:
Hidradenitis suppurativa
Janus kinase (JAK) inhibitor
skin disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration