Sonelokimab
Drugrandomized treatment; parallel group
Other names: M1095
NCT Number: NCT05640245
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Clinical Site, Pleven, Bulgaria
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
randomized treatment; parallel group
Other names: M1095
randomized treatment; parallel-group
randomized treatment; parallel-group
Time frame: Week 12
Proportion of participants who achieve ACR50 compared with baseline
Time frame: Week 2, 4, 8, 12
Proportion of participants who achieve ACR20 compared with baseline
Time frame: Week 4, 8, 12
Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Time frame: Weeks 2, 4, 8, 12
Proportion of participants who achieve ACR70 compared with baseline
Time frame: Weeks 4, 8, 12
Proportion of participants with resolution of enthesitis (LEI = 0)
Time frame: Weeks 4, 8, 12
Change from baseline for Leeds Dactylitis Index
Time frame: Week 12
Change from baseline for mNAPSI
Time frame: Weeks 4, 8, 12
Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
MoonLake Immunotherapeutics AG
Industry
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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