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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Guselkumab dose 2; Drug: Guselkumab dose 3; Drug: Placebo; Drug: Guselkumab dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628924

CR108500

CNTO1959HDS2001 (Other Identifier)

2018-001176-38 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 3 patient groups

Group 1: Guselkumab Regimen 1

Experimental group

Description:

Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.

Treatment:

Drug: Guselkumab dose 1

Drug: Placebo

Drug: Guselkumab dose 2

Group 2: Guselkumab Regimen 2

Experimental group

Description:

Participants will receive guselkumab dose 2 subcutaneously.

Treatment:

Drug: Placebo

Drug: Guselkumab dose 2

Group 3: Placebo then Guselkumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Guselkumab dose 3

Drug: Guselkumab dose 2