Sonelokimab
Sponsors
MoonLake Immunotherapeutics AG
Conditions
Arthritis, PsoriaticHidradenitis SuppurativaHidradenitis suppurativa (HS)Palmoplantar PustulosisPsoriatic arthritisRelative Bioequivalenceaxial spondyloarthritishidradenitis suppurativa (HS)
Phase 1
Phase 2
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
CompletedNCT05640245
Start: 2022-12-13End: 2024-01-15Updated: 2024-09-05
A Phase 2, multicentre open-label study to explore the effects of sonelokimab in patients with moderate-to-severe pustulosis palmoplantaris
CompletedCTIS2024-513305-32-00
Start: 2024-10-29End: 2025-09-30Target: 30Updated: 2025-07-29
A Phase 2 open-label imaging study to explore the effects of sonelokimab in patients with active axial spondyloarthritis
CompletedCTIS2024-513498-36-00
Start: 2024-12-23End: 2026-01-05Target: 25Updated: 2025-09-04
A Phase 2, open-label, imaging study to explore the effects of sonelokimab in patients with active psoriatic arthritis or axial spondyloarthritis
RecruitingCTIS2024-514504-13-00
Start: 2025-09-23Target: 30Updated: 2026-01-13
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
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
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
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
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
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
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
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
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
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
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
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
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
Target: 123Updated: 2026-02-26