Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Acti… (NCT05206591) | Clinical Trial Compass
WithdrawnPhase 3
Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
Stopped: Trial terminated due to strategic decision of senior management
0Started 2022-08-16
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of subcutaneous (s.c) secukinumab in comparison with placebo for participants with two subtypes of active pSpA i.e. undifferentiated pSpA and chronic reactive arthritis, and with an inadequate response to conventional therapy despite current or previous Non-steroidal Anti Inflammatory Drugs (NSAIDs) and/or csDMARDs. Additionally, the study aims to evaluate efficacy and safety of continuing versus withdrawing secukinumab therapy in maintaining remission in the study population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
✓. Male or non-pregnant, non-lactating female participants at least 18 years of age.
✓. Participant meets ASAS criteria for classification of pSpA:
✓. Diagnosis of pSpA with evidence of active disease as manifested by
✓. Rheumatoid Factor (RF) and Anti-cyclic citrullinated peptides (anti-CCP) antibodies negative at screening.
✓. Duration of symptoms of at least 6 months.
✓. Participant should have been on at least 2 different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
Exclusion criteria
✕. Current or previous diagnosis of :
✕. Meets ASAS axSpA criteria as manifested by ALL of:
✕. Score of ≥2 on numerical rating scale (NRS)-score for total back pain and nocturnal back pain (score 0-10)
✕. History of a confirmed diagnosis of any inflammatory joint disorder other than pSpA (e.g., rheumatoid arthritis, gouty arthritis, other crystalline arthritis, systemic lupus erythematosus, or any arthritis with onset prior to age 16 years such as juvenile idiopathic arthritis).