Evaluation of ERAP Inhibition in Patients with Axial Spondyloarthritis: The EAST-1 Clinical Trial

The primary objective of this study is to evaluate the efficacy of ERAP-inhibition in patients diagnosed with axial spondyloarthritis. This investigation focuses on the therapeutic potential of modulating the endoplasmic reticulum aminopeptidase (ERAP) pathway to mitigate disease activity. There are no secondary objectives reported.

This study involves a total of 48 participants consisting of patients and healthy volunteers. The study population includes both males and females within the specified age ranges of 3 to 4 years. Individuals in the patient group are diagnosed with axial spondyloarthritis.

The EAST-1 trial is a Phase 1 clinical study designed to evaluate ERAP-inhibition in patients diagnosed with axial spondyloarthritis. The research methodology utilizes a controlled design to assess the safety and pharmacological profile of the intervention. The study protocol involves a sequence of scheduled assessments, beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical parameters, concluding with an end-of-study visit to collect final data. The total duration of participant involvement is determined by the specific clinical milestones of the protocol. Early termination of participation may occur according to predefined clinical criteria or safety protocols.

The assessment of efficacy in this clinical trial involving axial spondyloarthritis is not specified.