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-DE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-01
• Last Update Posted: 20 July 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
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 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

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.