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 logo

Janssen

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

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

Trial documents
2

Trial contacts and locations

45

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems