Clinical Trials in the UK / NCT07007637
Enrolling by invitation
Phase 3
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
NCT07007637 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Hidradenitis Suppurativa
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab — 2.5-3 years
Incidence, relatedness, severity and seriousness of all AEs - Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs) — 2.5-3 years
Incidence, relatedness, severity and seriousness of all TEAEs - Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs) — 2.5-3 years
Incidence, relatedness, severity and seriousness of all AESIs - Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs — 2.5-3 years
Number of participants discontinued from sonelokimab treatment due to AEs - Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters — 2.5-3 years
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline - Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram — 2.5-3 years
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
Trial sites (166)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Site | Birmingham | Alabama | |
| Clinical Site | North Little Rock | Arkansas | |
| Clinical Site | Los Angeles | California | |
| Clinical Site | Northridge | California | |
| Clinical Site | Aventura | Florida | |
| Clinical Site | Coral Gables | Florida | |
| Clinical Site | Hialeah | Florida | |
| Clinical Site | Hollywood | Florida | |
| Clinical Site | Miami | Florida | |
| Clinical Site | Miami | Florida | |
| Clinical Site | Ocala | Florida | |
| Clinical Site | Tampa | Florida | |
| Clinical Site | Tampa | Florida | |
| Clinical Site | Macon | Georgia | |
| Clinical Site | Sandy Springs | Georgia | |
| Clinical Site | Skokie | Illinois | |
| Clinical Site | West Dundee | Illinois | |
| Clinical Site | Columbus | Indiana | |
| Clinical Site | New Albany | Indiana | |
| Clinical Site | Plainfield | Indiana | |
| Clinical Site | Louisville | Kentucky | |
| Clinical Site | Murray | Kentucky | |
| Clinical Site | Metairie | Louisiana | |
| Clinical Site | Boston | Massachusetts | |
| Clinical Site | Boston | Massachusetts | |
| Clinical Site | Ann Arbor | Michigan | |
| Clinical Site | Canton | Michigan | |
| Clinical Site | Clarkston | Michigan | |
| Clinical Site | Waterford | Michigan | |
| Clinical Site | New Brighton | Minnesota | |
| Clinical Site | Omaha | Nebraska | |
| Clinical Site | Las Vegas | Nevada | |
| Clinical Site | New York | New York | |
| Clinical Site | New York | New York | |
| Clinical Site | The Bronx | New York | |
| Clinical Site | Fargo | North Dakota | |
| Clinical Site | Boardman | Ohio | |
| Clinical Site | Columbus | Ohio | |
| Clinical Site | Dayton | Ohio | |
| Clinical Site | Oklahoma City | Oklahoma |
+ 126 more sites — see the full list on the official registry below.
More MoonLake Immunotherapeutics AG trials in the UK
Other trials for the same condition
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Active, not recruiting
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Active, not recruiting
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07007637 on ClinicalTrials.gov ↗ ← All trials in the UK