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

NCT03628924 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1085002018-001176-38CNTO1959HDS2001
• Study Type: interventional
• Target: 184
• Locations: 6 countries
• Sites: 45

Brief Summary

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).

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

  HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

  Week 16

Secondary Outcomes (21)

• Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16

  Baseline and Week 16

• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

  Baseline and Week 16

• Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16

  Baseline and Week 16

• Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

  Week 16

• Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

  Week 16

Study Arms (3)

Group 1: Guselkumab Regimen 1

EXPERIMENTAL

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

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

Group 2: Guselkumab Regimen 2

EXPERIMENTAL

Participants will receive guselkumab dose 2 subcutaneously.

Drug: Guselkumab dose 2; Drug: Placebo

Group 3: Placebo then Guselkumab

EXPERIMENTAL

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; Drug: Guselkumab dose 3; Drug: Placebo

Interventions

Guselkumab dose 1 DRUG

Participants will receive guselkumab dose 1 IV.

Also known as: CNTO 1959

Group 1: Guselkumab Regimen 1

Guselkumab dose 2 DRUG

Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.

Also known as: CNTO 1959

Group 1: Guselkumab Regimen 1; Group 2: Guselkumab Regimen 2; Group 3: Placebo then Guselkumab

Guselkumab dose 3 DRUG

Participants will receive guselkumab dose 3 SC in Group 3.

Also known as: CNTO 1959

Group 3: Placebo then Guselkumab

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.

Group 1: Guselkumab Regimen 1; Group 2: Guselkumab Regimen 2; Group 3: Placebo then Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (45)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Olympian Clinical Research

Largo, Florida, 33770, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Park Avenue Dermatology

Orange Park, Florida, 32073, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33624, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Clinical Studies Group

Henderson, Nevada, 89052, United States

Location

Ohio State University

Columbus, Ohio, 43215, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101-1498, United States

Location

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

Bispebjerg Hospital

København NV, DK-2400, Denmark

Location

Sjaellands University Hospital

Roskilde, DK-4000, Denmark

Location

Hopital Prive d'Antony

Antony, 92160, France

Location

Groupe Hospitalier La Rochelle - Re - Aunis

La Rochelle, 17019, France

Location

CHU de Nice

Nice, 06200, France

Location

Polyclinique de Courlancy

Reims, 51100, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

CHU Saint Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Hopital Larrey CHU de Toulouse

Toulouse, 31000, France

Location

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, 10117, Germany

Location

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

Location

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, 64297, Germany

Location

Stadtisches Klinikum Dresden

Dresden, 01067, Germany

Location

Universitaetsklinik Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Haut- und Laserzentrum Freising

Freising, 85354, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsmedizin Mainz

Mainz, 55131, Germany

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Radboudumc

Nijmegen, 6525GA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (1)

• Kimball AB, Podda M, Alavi A, Miller M, Shen YK, Li S, Xu Y, Han C, Fakharzadeh S, Yang YW, DePrimo S, Munoz E, Chen Y, Passeron T, Papp K. Guselkumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa: A phase 2 randomized study. J Eur Acad Dermatol Venereol. 2023 Oct;37(10):2098-2108. doi: 10.1111/jdv.19252. Epub 2023 Jun 27.

  PMID: 37317022 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Product development portfolio leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: September 4, 2018
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: February 4, 2025
• Results First Posted: June 14, 2021

Record last verified: 2025-01

Locations

CA (4); DK (2); US (20); FR (7); DE (9); NL (3)