Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)

Launched by MERCK SHARP & DOHME LLC · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new medication called tulisokibart for people with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes bumps and abscesses. The study will compare the effects of tulisokibart to a placebo (a non-active treatment) to see if it helps reduce HS symptoms more effectively. Participants will be monitored over 16 weeks to determine if they experience at least a 50% improvement in their condition.

To be eligible for this trial, participants must have been diagnosed with HS for at least six months and have had moderate or severe symptoms. They should also have not responded well to antibiotics or cannot take them due to side effects. The study is open to adults aged 18 to 65 and will involve regular check-ins to track their progress. It’s important to note that individuals with other active skin conditions or certain health issues may not be able to participate. If you or someone you know is living with HS and is interested in this trial, it could be a potential opportunity to access a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months and a clinical diagnosis of HS at screening
• • Has moderate or severe HS
• • Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
• • Has ≤20 draining tunnel count at Screening and Randomization
• Exclusion Criteria:
• • Has other active skin conditions that may interfere with the assessment of HS
• • Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
• • Has a transplanted organ and requires continued systemic immunosuppression
• • Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
• • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients