A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

Phase 1

• Conditions: Moderate to Severe Hidradenitis Suppurativa; MedDRA version: 20.0Level: LLTClassification code 10076650Term: Acne inversaSystem Organ Class: 100000004858; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-001176-38-FR
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
-Have moderate to severe HS for at least 1 year (365 days) prior to the baseline visit.
-Have HS lesions present in at least 2 distinct anatomic areas.
-Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS.
-Have stable HS for at least 1 month (28 days) prior to the screening visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

-Any other active skin disease or condition that could have interfered with assessment of HS.
-Has a draining fistula count of >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 <4 weeks prior to the baseline visit.
-Receipt of immunomodulatory biologic therapies (eg monoclonal antibodies) within 3 months or 5 half-lives prior to the baseline visit, whichever is longer.
-Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 weeks prior to the baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objectives of this study are:<br>- To evaluate the efficacy of guselkumab in adult participants with moderate to severe HS during the maintenance phase.<br>- To evaluate the effect of guselkumab on the dermatologic health-related quality of life in adult participants with moderate to severe HS.<br>- To evaluate the PK, immunogenicity, and PD of guselkumab therapy in adult participants with moderate to severe HS.<br>;Primary end point(s): The proportion of participants achieving HiSCR;Timepoint(s) of evaluation of this end point: At Week 16;Main Objective: The primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe HS.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Major Secondary Endpoints:<br>1) The change from baseline in total abscess and inflammatory nodule (AN) count at Week 16.<br>2) The change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16.<br>3) The change from baseline in HS-related pain in the past 24 hours based on Hidradenitis Suppurativa Symptom Diary (HSSD) at Week 16.<br>;Timepoint(s) of evaluation of this end point: For all major secondary endpoints, timepoints are the same, at Week 16.