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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03628924
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Sep 4, 2018
Status verified
Jan 2025
Primary completion
May 22, 2020
Completion
May 22, 2020

Study Design

Enrollment
184 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 [ Time Frame: Week 16 ]

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
Olympian Clinical ResearchLargoFlorida33770-
Renstar Medical ResearchOcalaFlorida34470-
Park Avenue DermatologyOrange ParkFlorida32073-
Forcare Clinical Research IncTampaFlorida33624-
Olympian Clinical ResearchTampaFlorida33614-
Great Lakes Clinical TrialsChicagoIllinois60640-
Indiana Clinical Trial CenterPlainfieldIndiana46168-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
Hamzavi DermatologyFort GratiotMichigan48059-
Central DermatologySt LouisMissouri63117-
Clinical Studies GroupHendersonNevada89052-
Ohio State UniversityColumbusOhio43215-
Oregon Medical Research CenterPortlandOregon97223-
University of Pittsburgh Department of DermatologyPittsburghPennsylvania15213-
Clinical Partners, LLCJohnstonRhode Island02919-
Progressive Clinical ResearchSan AntonioTexas78213-
Dermatology Associates of SeattleSeattleWashington98101-1498-

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama Birmingham· Birmingham, ALOlympian Clinical Research· Largo, FLRenstar Medical Research· Ocala, FLPark Avenue Dermatology· Orange Park, FLForcare Clinical Research Inc· Tampa, FLOlympian Clinical Research· Tampa, FL

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