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Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinical Site
Rancho Mirage, California, United States
Clinical Site
Duncansville, Pennsylvania, United States
Clinical Site
Pleven, Bulgaria
Clinical Site
Pleven, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Rousse, Bulgaria
Clinical Site
Sofia, Bulgaria
Clinical Site
Stara Zagora, Bulgaria
Clinical Site
Varna, Bulgaria
Start Date
December 13, 2022
Primary Completion Date
September 5, 2023
Completion Date
January 15, 2024
Last Updated
September 5, 2024
207
ACTUAL participants
Sonelokimab
DRUG
Placebo
DRUG
Adalimumab
DRUG
Lead Sponsor
MoonLake Immunotherapeutics AG
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00741793