Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study.

NCT ID: NCT04061395

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hidradenitis Suppurativa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Guselkumab

Guselkumab 200 mg Q4W; subcutaneous injections; duration of 16 weeks.

Group Type EXPERIMENTAL

Guselkumab

Intervention Type BIOLOGICAL

See study arm description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guselkumab

See study arm description.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tremfya

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erasmus MC, University Medical Center Rotterdam

Rotterdam, South Holland, Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNTO1959HDS2002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Etanercept in Hidradenitis Suppurativa
NCT00329823 COMPLETED PHASE2
Anifrolumab for Hidradenitis Suppurativa
NCT06374212 ACTIVE_NOT_RECRUITING PHASE2