A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- MoonLake Immunotherapeutics AG
- Study ID
- NCT07007637
- Phase
- PHASE3
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sonelokimab — DRUGSonelokimab
Study Details
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.
Key Dates
- Start date
- Jun 27, 2025
- Status verified
- Jun 2026
- Primary completion
- Jun 13, 2028
- Completion
- Jun 13, 2028
Study Design
- Enrollment
- 835 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental: sonelokimabAll participants will receive sonelokimab 120 mg Q4W for up to 2 years
Primary Outcome Measure
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab [ Time Frame: 2.5-3 years ]
Locations (49)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Site | Birmingham | Alabama | 35244 | - |
| Clinical Site | North Little Rock | Arkansas | 72117 | - |
| Clinical Site | Los Angeles | California | 90404 | - |
| Clinical Site | Northridge | California | 91325 | - |
| Clinical Site | Aventura | Florida | 33180 | - |
| Clinical Site | Coral Gables | Florida | 33134 | - |
| Clinical Site | Hialeah | Florida | 33012 | - |
| Clinical Site | Hollywood | Florida | 33021-6746 | - |
| Clinical Site | Miami | Florida | 33136 | - |
| Clinical Site | Miami | Florida | 33163 | - |
| Clinical Site | Ocala | Florida | 34471 | - |
| Clinical Site | Tampa | Florida | 33607 | - |
| Clinical Site | Tampa | Florida | 33613 | - |
| Clinical Site | Macon | Georgia | 31217 | - |
| Clinical Site | Sandy Springs | Georgia | 30328 | - |
| Clinical Site | Skokie | Illinois | 60077 | - |
| Clinical Site | West Dundee | Illinois | 60118 | - |
| Clinical Site | Columbus | Indiana | 47201 | - |
| Clinical Site | New Albany | Indiana | 47150 | - |
| Clinical Site | Plainfield | Indiana | 46168 | - |
| Clinical Site | Louisville | Kentucky | 40241 | - |
| Clinical Site | Murray | Kentucky | 42071 | - |
| Clinical Site | Metairie | Louisiana | 70006 | - |
| Clinical Site | Boston | Massachusetts | 02116 | - |
| Clinical Site | Boston | Massachusetts | 02215 | - |
| Clinical Site | Ann Arbor | Michigan | 48109-5314 | - |
| Clinical Site | Canton | Michigan | 48187 | - |
| Clinical Site | Clarkston | Michigan | 48346 | - |
| Clinical Site | Waterford | Michigan | 48328 | - |
| Clinical Site | New Brighton | Minnesota | 55112 | - |
| Clinical Site | Omaha | Nebraska | 68144 | - |
| Clinical Site | Las Vegas | Nevada | 89148 | - |
| Clinical Site | New York | New York | 10003 | - |
| Clinical Site | New York | New York | 10012 | - |
| Clinical Site | The Bronx | New York | 10467 | - |
| Clinical Site | Fargo | North Dakota | 58103 | - |
| Clinical Site | Boardman | Ohio | 44512 | - |
| Clinical Site | Columbus | Ohio | 43213 | - |
| Clinical Site | Dayton | Ohio | 45324 | - |
| Clinical Site | Oklahoma City | Oklahoma | 73118 | - |
| Clinical Site | Murfreesboro | Tennessee | 37130 | - |
| Clinical Site | Dallas | Texas | 75235 | - |
| Clinical Site | Dallas | Texas | 75246 | - |
| Clinical Site | Houston | Texas | 77004 | - |
| Clinical Site | San Antonio | Texas | 78213 | - |
| Clinical Site | San Antonio | Texas | 78218 | - |
| Clinical Site | South Jordan | Utah | 84095 | - |
| Clinical Site | Mill Creek | Washington | 98012 | - |
| Clinical Site | Morgantown | West Virginia | 26505 | - |
Find similar trials in Birmingham, AL
By condition
By specialty
Related Studies
- The Ohio State University Dermatology BiorepositoryRecruiting · Ohio State University · Columbus, Ohio
- Clinical and Biological Characteristics of Hidradenitis SuppurativaRecruiting · University of California, San Francisco · San Francisco, California
- Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen RepositoryRecruiting · University of California, San Francisco · San Francisco, California
- Battlefield Acupuncture for Pain in Hidradenitis SuppurativaRecruiting · Wayne State University · Dearborn, Michigan