A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

Launched by ABBVIE · Nov 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called lutikizumab (ABT-981) for adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and abscesses. The trial aims to see how effective and safe lutikizumab is for people who have not had success with existing treatments, specifically anti-TNF therapy. About 160 participants will receive either lutikizumab or a placebo (a treatment with no active medication) through injections every week for 16 weeks. There is also a smaller sub-study for around 40 participants who have not used biologic therapy before, where they will receive lutikizumab for a longer period with different dosing schedules.

To be eligible for this trial, participants must have been diagnosed with HS for at least a year, have at least five abscesses or inflammatory lumps, and have previously tried and not benefited from anti-TNF treatment. Throughout the study, participants will attend regular visits for check-ups, blood tests, and assessments to monitor their health and any side effects. It’s important to note that this trial may require more time and effort than usual treatments, but it could provide valuable insights into a new option for managing HS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • To be eligible for the Sub-study, participants must be naïve to biologic therapy for treatment of HS.
• 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.