Drug research

Sonelokimab

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as M1095

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

TrialSponsorPhaseStatusPrimary completion
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic DrugNCT06641076MoonLake Immunotherapeutics AGPhase 3Active not recruiting2027-02-04Estimated
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate ResponseNCT06641089MoonLake Immunotherapeutics AGPhase 3Recruiting2027-01-15Estimated
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaNCT06411379MoonLake Immunotherapeutics AGPhase 3Completed2025-08-14Actual
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis SuppurativaNCT07007637MoonLake Immunotherapeutics AGPhase 3Enrolling by invitation2028-06-13Estimated
An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)NCT06768671MoonLake Immunotherapeutics AGPhase 3Active not recruiting2026-09-28Estimated
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic ArthritisNCT07223138MoonLake Immunotherapeutics AGPhase 3Enrolling by invitation2028-02-04Estimated
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaNCT06411899MoonLake Immunotherapeutics AGPhase 3Completed2025-09-02Actual
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic ArthritisNCT05640245MoonLake Immunotherapeutics AGPhase 2Completed2023-09-05Actual

Regulatory dates and decisions

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.