NCT05640245Phase 2Completed

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Study sponsor: MoonLake Immunotherapeutics AG

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-05Actual

Enrollment · participants207Actual

Source updated2026-09-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-09-10 · 1 field changed

Main study measure wording changed

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− Before

Measure: ~~Response Rate~~ of ~~participants~~ ~~achieving~~ ~~at least a 50% improvement in the~~ American College of Rheumatology ~~criteria~~ (ACR50)

+ After

Measure: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12

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Study details

Conditions studied

Arthritis, Psoriatic

Treatments or interventions studied

SonelokimabDrugAlso known as M1095
PlaceboDrug
AdalimumabDrug

Primary outcomes · main study measures

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measure: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12; description: The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.; timeFrame: At Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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