Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

Hidradenitis Suppurativa Clinical Trial

— HiGUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061395
• Other study ID #: CNTO1959HDS2002
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• moderate to severe HS

• treatment history of at least one systemic anti-in?ammatory / 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Biological:
• Guselkumab
See study arm description.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Erasmus MC, University Medical Center Rotterdam	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Janssen-Cilag Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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