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 — DRUG
    Sonelokimab

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: sonelokimab
    All 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)

FacilityCityStateZIPSite coordinators
Clinical SiteBirminghamAlabama35244-
Clinical SiteNorth Little RockArkansas72117-
Clinical SiteLos AngelesCalifornia90404-
Clinical SiteNorthridgeCalifornia91325-
Clinical SiteAventuraFlorida33180-
Clinical SiteCoral GablesFlorida33134-
Clinical SiteHialeahFlorida33012-
Clinical SiteHollywoodFlorida33021-6746-
Clinical SiteMiamiFlorida33136-
Clinical SiteMiamiFlorida33163-
Clinical SiteOcalaFlorida34471-
Clinical SiteTampaFlorida33607-
Clinical SiteTampaFlorida33613-
Clinical SiteMaconGeorgia31217-
Clinical SiteSandy SpringsGeorgia30328-
Clinical SiteSkokieIllinois60077-
Clinical SiteWest DundeeIllinois60118-
Clinical SiteColumbusIndiana47201-
Clinical SiteNew AlbanyIndiana47150-
Clinical SitePlainfieldIndiana46168-
Clinical SiteLouisvilleKentucky40241-
Clinical SiteMurrayKentucky42071-
Clinical SiteMetairieLouisiana70006-
Clinical SiteBostonMassachusetts02116-
Clinical SiteBostonMassachusetts02215-
Clinical SiteAnn ArborMichigan48109-5314-
Clinical SiteCantonMichigan48187-
Clinical SiteClarkstonMichigan48346-
Clinical SiteWaterfordMichigan48328-
Clinical SiteNew BrightonMinnesota55112-
Clinical SiteOmahaNebraska68144-
Clinical SiteLas VegasNevada89148-
Clinical SiteNew YorkNew York10003-
Clinical SiteNew YorkNew York10012-
Clinical SiteThe BronxNew York10467-
Clinical SiteFargoNorth Dakota58103-
Clinical SiteBoardmanOhio44512-
Clinical SiteColumbusOhio43213-
Clinical SiteDaytonOhio45324-
Clinical SiteOklahoma CityOklahoma73118-
Clinical SiteMurfreesboroTennessee37130-
Clinical SiteDallasTexas75235-
Clinical SiteDallasTexas75246-
Clinical SiteHoustonTexas77004-
Clinical SiteSan AntonioTexas78213-
Clinical SiteSan AntonioTexas78218-
Clinical SiteSouth JordanUtah84095-
Clinical SiteMill CreekWashington98012-
Clinical SiteMorgantownWest Virginia26505-

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