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: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-004108-33-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-16
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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