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

Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. (HiGUS)

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. Identifier: NCT04061395
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 21, 2019
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Barbara Horváth, Principal Investigator, University Medical Center Groningen

Brief Summary:

This is a multicenter open-label mode of action study. Twenty patients with moderate to severe hidradenitis suppurativa will be treated with guselkumab 200 mg Q4W subcutaneously. Main objectie is to investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin.

The total duration of the treatment period per subject is 16 weeks.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: Guselkumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Guselkumab
Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
Biological: Guselkumab
See study arm description.
Other Name: Tremfya

Primary Outcome Measures :
  1. Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab. [ Time Frame: Week 0 and 16 ]
    Pangenomic gene expression profiling at week 0 and week 16 will be performed on skin biopsies to investigate changes in levels of cytokines in the skin.

Secondary Outcome Measures :
  1. Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 0, 4, 12, 16. ]
    All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.

  2. Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4). [ Time Frame: Week 0, 4, 12, 16. ]
    The IHS4 score will be calculated by multiplying the number of nodules by 1, the number of abscesses by 2 and the number of draining fistulas by 4 and adding up these three outcomes into a total score.

  3. Patient reported outcomes - Patient Global Assessment [ Time Frame: Every four weeks ]
    Patient will be asked to assess his or her skin disease activity with in 5 categories.

  4. Patient reported outcomes - Itch Numeric Rating Scale [ Time Frame: Week 0, 4, 8, 12 and 16 ]
    Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).

  5. Patient reported outcomes - Pain Numeric Rating Scale [ Time Frame: Week 0, 4, 8, 12 and 16 ]
    Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).

  6. Patient reported outcomes - Patient treatment satisfaction score [ Time Frame: Week 0 and 16 ]
    Patient will be asked to score his or her satisfaction about the treatment at baseline and at week 16 on a numeric rating scale from 0 (completely unsatisfied) to 10 (completely satisfied).

  7. Patient reported outcomes - Dermatology Life Quality Index [ Time Frame: Week 0, 4, 8, 12 and 16 ]
    A survey containing 10 questions regarding multiple aspects of the quality of life. Each question has 4 answer possibilities: 'not at all', 'a little', 'a lot' and 'very much'. These answers correspond with 0,1,2 or 3 points respectively. The total score can range from 0 to 30 points.

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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • moderate to severe HS
  • treatment history of at least one systemic anti-inflammatory / immunosuppressive agent;
  • HS diagnosis of at least 1 year;
  • minimum of two anatomical locations with HS lesions
  • minimum of 4 active abscesses and/or inflammatory nodules (AN).

Key Exclusion Criteria:

  • contra-indication for guselkumab;
  • previous use of guselkumab;
  • use of treatment with biologics or any immunosuppressives for HS in the last 3 months prior to randomization;
  • presence of other uncontrolled major disease;
  • pregnant or lactating women

Layout table for additonal information
Responsible Party: Barbara Horváth, Principal Investigator, Principial Investigator, Dermatologist, Interim Head of Department of Dermatology., University Medical Center Groningen Identifier: NCT04061395    
Other Study ID Numbers: CNTO1959HDS2002
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs