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Trial record 27 of 90 for:    hidradenitis suppurativa

A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03607487
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : January 4, 2019
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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

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

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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 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


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

Locations
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Canada, Manitoba
Wiseman Dermatology Research Not yet recruiting
Winnipeg, Manitoba, Canada, R3M 3Z4
Contact: Study Coordinator Lovie Anderson    204-943-4922    Lovie@skinwise.ca   
Principal Investigator: Marni Wiseman         
Canada, New Brunswick
Brunswick Dermatology Center Recruiting
Fredericton, New Brunswick, Canada, E3B 1G9
Contact: Study Coordinator Shannon Bolduc    506-459-1808    s_ashworth@live.com   
Principal Investigator: Irina Turchin         
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center Recruiting
Barrie, Ontario, Canada, L4M 7G1
Contact: Study Coordinator Carol Morrison    705-503-6331    carol.morrison@simcoderm.com   
Principal Investigator: Maryam Shayesteh Alam         
DermEffects Recruiting
London, Ontario, Canada, N6H 5L5
Contact: Study Coordinator Christina Craig    519-472-2929    dermeffects2@gmail.com   
Principal Investigator: Wei Jing Loo         
Lynderm Research Inc. Not yet recruiting
Markham, Ontario, Canada, L3P 1X2
Contact: Study Coordinator Monica Soliman    905 471 8011    monica@lynderma.com   
Principal Investigator: Charles Lynde         
York Dermatology Center Recruiting
Richmond Hill, Ontario, Canada, L4C 9M7
Contact: Study Coordinator Afkham Amiri    (905) 883-4472    afkham@afsanehalavi.com   
Principal Investigator: Afsaneh Alavi         
Windsor Clinical Research, Inc Not yet recruiting
Windsor, Ontario, Canada, N8W 5L7
Contact: Study Coordinator Shannon Moore    519-971-7693    wcri@bellnet.ca   
Principal Investigator: Jerry Tan         
Canada, Quebec
Dr Isabelle Delorme Inc. Not yet recruiting
Drummondville, Quebec, Canada, J2B 5L4
Contact: Study Coordinator Denise Chouinard    819-850-3790 ext 31    dchouinard@dredelorme.com   
Principal Investigator: Isabelle Delorme         
Dre Angelique Gagne-Henley MD inc. Recruiting
St-Jerome, Quebec, Canada, J7Z 7E2
Contact: Study Coordinator Guillaume Morissette    450-565-6522    mori7g@gmail.com   
Principal Investigator: Angélique Gagné-Henley         
Denmark
Aarhus University hospital Afdeling for hud- og kønssygdomme Not yet recruiting
Aarhus, Denmark, 8200
Contact       madsrasm@rm.dk   
Principal Investigator: Mads Rasmussen         
Sjællands universitetshospital, Roskilde Dermatologisk afdeling Not yet recruiting
Roskilde, Denmark, 4000
Contact       gbj@regionsjaelland.dk   
Principal Investigator: Gregor Jemec         
Germany
Universitätsklinikum Münster Abteilung für Dermatologie Not yet recruiting
Münster, North Rhine-Westphalia, Germany, 48149
Contact: Nina Magnolo       Nina.Magnolo@ukmuenster.de   
Ruhr-Universität Bochum Dermatologische Studienambulanz Haus J, 1. Etage Not yet recruiting
Bochum, Noth Rhine-Westphalia, Germany, 44791
Contact: Falk G. Bechara       F.Bechara@klinikum-bochum.de   
Universitätsklinikum Schleswig-Holstein Institut für Entzündungsmedizin Not yet recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Diamant Thaci       diamant.thaci@uksh.de   
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: NCT03607487     History of Changes
Other Study ID Numbers: INCB 54707-203
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 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
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:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration