Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Part of paid clinical trials in Avondale, Arizona.

Sponsor
MoonLake Immunotherapeutics AG
Study ID
NCT06641089
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonelokimab — DRUG
    Sonelokimab
  • Placebo — DRUG
    Placebo
  • Risankizumab — DRUG
    Active comparator

Study Details

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Key Dates

Start date
Oct 15, 2024
Status verified
May 2026
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: sonelokimab dose 1 with an induction regimen
    Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
  • Experimental: sonelokimab dose 2 with an induction regimen
    Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo SC
  • Active Comparator: risankizumab
    Subjects randomized to this arm will receive risankizumab SC

Primary Outcome Measure

Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [ Time Frame: Week 16 compared to placebo ]

Central Contacts

Locations (44)

FacilityCityStateZIPSite coordinators
Clinical SiteAvondaleArizona85392-
Clinical SiteChandlerArizona85225-
Clinical SiteFlagstaffArizona86001-
Clinical SiteMesaArizona85210-
Clinical SitePhoenixArizona85032-
Clinical SiteScottsdaleArizona85260-
Clinical SiteTucsonArizona85748-
Clinical SiteJonesboroArkansas72401-
Clinical SiteLa JollaCalifornia92037-
Clinical SitePomonaCalifornia91767-
Clinical SiteSan DiegoCalifornia92108-
Clinical SiteSanta MonicaCalifornia90404-
Clinical SiteThousand OaksCalifornia91360-
Clinical SiteUplandCalifornia91786-
Clinical SiteAvon ParkFlorida33825-
Clinical SiteClearwaterFlorida33765-
Clinical SiteHialeahFlorida33016-
Clinical SiteMiami GardensFlorida33014-
Clinical SiteTampaFlorida33607-
Clinical SiteZephyrhillsFlorida33542-
Clinical SiteGainesvilleGeorgia30501-
Clinical SiteSpringfieldIllinois62702-
Clinical SiteLake CharlesLouisiana70605-
Clinical SiteBaltimoreMaryland21224-6821-
Clinical SiteGrand BlancMichigan48439-2451-
Clinical SiteBrooklynNew York11201-
Clinical SiteRochesterNew York14642-
Clinical SiteCharlotteNorth Carolina28262-
Clinical SiteLelandNorth Carolina28451-
Clinical SiteMiddleburg HeightsOhio44130-
Clinical SitePortlandOregon97239-
Clinical SiteDuncansvillePennsylvania16635-
Clinical SiteJacksonTennessee38305-
Clinical SiteMemphisTennessee38119-
Clinical SiteMurfreesboroTennessee37128-
Clinical SiteAllenTexas75013-
Clinical SiteAustinTexas78745-
Clinical SiteBaytownTexas77521-
Clinical SiteColleyvilleTexas76034-
Clinical SiteHoustonTexas77089-
Clinical SiteLubbockTexas79424-
Clinical SitePlanoTexas75024-
Clinical SiteSeattleWashington98122-
Clinical SiteBeckleyWest Virginia25801-

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