At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)
In Brief
A Phase 4 clinical trial evaluating 150 mg open-label secukinumab, 150 mg double-blinded secukinumab, and 1 other intervention for Ankylosing Spondylitis. Completed, enrolled 322 participants across 65 sites.
Detailed Summary
This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
Study Details
Timeline
Interventions
All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.
Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)
Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)