A Study Evaluating the Safety and Efficacy of Lutikizumab (ABT-981) Versus Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Phase 1

Conditions: Hidradenitis Suppurativa
MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2020-004108-33-GR

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

- Subjects must be = 18 years of age at Screening with a clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
- A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
- HS lesions must be present in at least 2 distinct anatomic areas.
- Must have failed anti-TNF treatment for HS.

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of 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 assess the safety and efficacy of two different doses of lutikizumab, a high dose administered every week (EW) or every other week (EOW), and a low dose administered EOW, versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult subjects who have failed anti-TNF therapy.<br>;Secondary Objective: The secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS = 3.<br>;Primary end point(s): The primary endpoint is the achievement of HiSCR at Week 16. HiSCR is defined as at least a 50% reduction from Baseline in the total AN count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.;Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint is the achievement of at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain) at Week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among subjects with baseline NRS = 3.;Timepoint(s) of evaluation of this end point: Week 16

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