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Sonelokimab

DRUG18 trials

Sponsors

MoonLake Immunotherapeutics AG

Conditions

Arthritis, PsoriaticHidradenitis SuppurativaHidradenitis suppurativa (HS)Palmoplantar PustulosisPsoriatic arthritisRelative Bioequivalenceaxial spondyloarthritishidradenitis suppurativa (HS)

Phase 1

Phase 2

Phase 3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Active, not recruitingNCT06411899
MoonLake Immunotherapeutics AGHidradenitis Suppurativa
Start: 2024-05-15End: 2026-06-17Updated: 2025-05-21
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Active, not recruitingNCT06411379
MoonLake Immunotherapeutics AGHidradenitis Suppurativa
Start: 2024-05-14End: 2026-06-17Updated: 2025-05-21
A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-301)
RecruitingCTIS2024-511360-87-00
MoonLake Immunotherapeutics AGhidradenitis suppurativa (HS)
Start: 2024-10-02Target: 262Updated: 2025-09-08
A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-302)
Active, not recruitingCTIS2024-511363-28-00
MoonLake Immunotherapeutics AGhidradenitis suppurativa (HS)
Start: 2024-09-24Target: 292Updated: 2025-11-07
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
Active, not recruitingNCT06641076
MoonLake Immunotherapeutics AGArthritis, Psoriatic
Start: 2024-10-15End: 2027-02-04Target: 960Updated: 2026-03-30
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
RecruitingNCT06641089
MoonLake Immunotherapeutics AGArthritis, Psoriatic
Start: 2024-10-15End: 2027-01-15Target: 600Updated: 2026-03-30
An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)
RecruitingNCT06768671
MoonLake Immunotherapeutics AGHidradenitis Suppurativa
Start: 2024-12-30End: 2026-03-27Target: 35Updated: 2025-12-15
A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors
RecruitingCTIS2024-516219-25-00
MoonLake Immunotherapeutics AGpsoriatic arthritis
Start: 2025-03-25Target: 372Updated: 2026-01-23
A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who are naive to biologic DMARDs
RecruitingCTIS2024-516213-20-00
MoonLake Immunotherapeutics AGPsoriatic arthritis
Start: 2025-03-25Target: 590Updated: 2025-10-17
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Enrolling by invitationNCT07007637
MoonLake Immunotherapeutics AGHidradenitis Suppurativa
Start: 2025-06-27End: 2028-06-13Target: 835Updated: 2026-03-09
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
RecruitingCTIS2025-520564-17-00
MoonLake Immunotherapeutics AGHidradenitis suppurativa (HS)
Start: 2025-10-16Target: 492Updated: 2025-12-23
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
Enrolling by invitationNCT07223138
MoonLake Immunotherapeutics AGArthritis, Psoriatic
Start: 2025-11-13End: 2028-02-04Target: 1560Updated: 2026-03-27
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
Not yet recruitingCTIS2025-522471-28-00
MoonLake Immunotherapeutics AGpsoriatic arthritis (PsA)
Target: 123Updated: 2026-02-26

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