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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

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

ArmDescriptionAssigned Intervention
Experimental
Group 1: Guselkumab Regimen 1 		Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.
  • Drug: Guselkumab dose 1
    Participants will receive guselkumab dose 1 IV.
    Other names:
    • CNTO 1959
  • Drug: Guselkumab dose 2
    Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
    Other names:
    • CNTO 1959
  • 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.
Experimental
Group 2: Guselkumab Regimen 2 		Participants will receive guselkumab dose 2 subcutaneously.
  • Drug: Guselkumab dose 2
    Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
    Other names:
    • CNTO 1959
  • 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.
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.
  • Drug: Guselkumab dose 2
    Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
    Other names:
    • CNTO 1959
  • Drug: Guselkumab dose 3
    Participants will receive guselkumab dose 3 SC in Group 3.
    Other names:
    • CNTO 1959
  • 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.

More Details

Status
Completed
Sponsor
Janssen Research & Development, LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.