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Trial record 50 of 192 for:    Recruiting, Not yet recruiting, Available Studies | Pharmacology

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

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ClinicalTrials.gov Identifier: NCT04061395
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
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

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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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

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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:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs