Skip to main content
OpenTrials
Completed

NCT Number: NCT04061395

Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus MC, University Medical Center Rotterdam, Rotterdam, South Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guselkumab

Biological

See study arm description.

Other names: Tremfya

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. The HiGUS-trial

Acronym: HiGUS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2019
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.