A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

Launched by MOONLAKE IMMUNOTHERAPEUTICS AG · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate the long-term safety, tolerability, and effectiveness of a medication called sonelokimab for people with moderate to severe hidradenitis suppurativa (HS), a painful skin condition. Participants in this study must have completed a previous study (referred to as the "parental study") and be eligible to continue receiving the treatment. The trial is not yet recruiting participants, but it aims to include both men and women of all ages who meet specific criteria, such as being healthy enough to participate and not being pregnant or breastfeeding.

If eligible, participants can expect to receive sonelokimab and be monitored for how well they tolerate the treatment and its effects on their condition over time. It's important for male participants to take precautions like using condoms during sexual activity and to avoid donating sperm while in the study and for a period afterward. The trial will not allow participants who are currently using certain other treatments for HS or who plan to participate in another study involving a different treatment. Overall, this trial hopes to provide valuable information about the ongoing use of sonelokimab for managing hidradenitis suppurativa.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
• • Female participants are eligible to participate if they are not pregnant or breastfeeding
• • Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
• Exclusion Criteria:
• • Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
• • Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
• • Participants who plan to participate in another interventional study for a drug or device during this study.