A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Purpose
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).
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history - Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) - Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigator's opinion - Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 3 at the screening and baseline visit - Must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath
Exclusion Criteria
- Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS - Has a draining fistula count of greater than (>) 20 at the baseline visit - Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit - Receipt of systemic non-biologic therapies for the treatment of HS less than (<) 4 Weeks prior to the baseline visit - Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Group 1: Guselkumab Regimen 1 |
Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously. |
|
Experimental Group 2: Guselkumab Regimen 2 |
Participants will receive guselkumab dose 2 subcutaneously. |
|
Experimental Group 3: Placebo then Guselkumab |
Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC. |
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More Details
- Status
- Completed
- Sponsor
- Janssen Research & Development, LLC