CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 184 enrolled
Drug / intervention
Guselkumab dose 1 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03628924
NCT03628924Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

Janssen Research & Development, LLC·interventional·Posted Aug 14, 2018·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating Guselkumab dose 1, Guselkumab dose 2, and 2 other interventions for Hidradenitis Suppurativa. Completed, enrolled 184 participants across 45 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHidradenitis Suppurativa
CountriesCanada, Denmark, France, Germany, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartSep 4, 2018
Primary CompletionMay 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.9 years ago

Interventions

Guselkumab dose 1drug

Participants will receive guselkumab dose 1 IV.

Guselkumab dose 2drug

Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.

Guselkumab dose 3drug

Participants will receive guselkumab dose 3 SC in Group 3.

Placebodrug

Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.