NCT03628924

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Guselkumab dose 1	Participants will receive guselkumab dose 1 IV.
DRUG	Guselkumab dose 2	Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
DRUG	Guselkumab dose 3	Participants will receive guselkumab dose 3 SC in Group 3.
DRUG	Placebo	Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.

Timeline

• Start date: 2018-09-04
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2018-08-14
• Last updated: 2025-02-04
• Results posted: 2021-06-14

Locations

45 sites across 6 countries: United States, Canada, Denmark, France, Germany, Netherlands

Regulatory

• FDA-regulated drug study