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

MoonLake Immunotherapeutics

Status and phase

Invitation-only

Phase 3

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Sonelokimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07007637

VELA-OLE (Other Identifier)

M1095-HS-303

Details and patient eligibility

About

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Enrollment

835 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.