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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.
 
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

Tracking Information
First Submitted Date  ICMJE August 9, 2019
First Posted Date  ICMJE August 19, 2019
Last Update Posted Date August 21, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04061395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.
Official Title  ICMJE Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Biological: Guselkumab
See study arm description.
Other Name: Tremfya
Study Arms  ICMJE Experimental: Guselkumab
Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.
Intervention: Biological: Guselkumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04061395
Other Study ID Numbers  ICMJE CNTO1959HDS2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Horváth, Principal Investigator, University Medical Center Groningen
Study Sponsor  ICMJE Barbara Horváth, Principal Investigator
Collaborators  ICMJE Janssen-Cilag Ltd.
Investigators  ICMJE Not Provided
PRS Account University Medical Center Groningen
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP