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

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

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Biological: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands
      • Erasmus MC, University Medical Center Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab.	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.	Week 0 and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy - Inflammatory lesion count and Hidradenitis Suppurativa Clinical Response (HiSCR)	All inflammatory lesions on all affected body areas will be counted. Additionally, the HiSCR will be calculated from these counted lesions.	Week 0, 4, 12, 16.
Clinical efficacy - International Hidradenitis Suppurativa Severity Score System (IHS4).	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.	Week 0, 4, 12, 16.
Patient reported outcomes - Patient Global Assessment	Patient will be asked to assess his or her skin disease activity with in 5 categories.	Every four weeks
Patient reported outcomes - Itch Numeric Rating Scale	Patient will be asked to score his or her itch on numeric rating scale from 0 (no itch) to 10 (worst possible itch).	Week 0, 4, 8, 12 and 16
Patient reported outcomes - Pain Numeric Rating Scale	Patient will be asked to score his or her pain on numeric rating scale from 0 (no pain) to 10 (worst possible pain).	Week 0, 4, 8, 12 and 16
Patient reported outcomes - Patient treatment satisfaction score	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).	Week 0 and 16
Patient reported outcomes - Dermatology Life Quality Index	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.	Week 0, 4, 8, 12 and 16

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Janssen-Cilag Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CNTO1959HDS2002

Drug and device information, study documents

• 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