Project
SpA: AIN 457F2320
Completed · 2015 until 2018
Müller Rüdiger, Forrer Silvia, Bartz-Batliner Mira, Hutz Carina Liane, Schmidig Kathrin
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2015
End Date
2018
Financing
Others
Study Design
This is a randomized, double-blind, placebo-controlled, parallel-group study. Approximately
324 patients will be randomized to one of three treatment groups (secukinumab 150 mg Load,
secukinumab 150 mg No Load, placebo, in a ratio of 1:1:1):
• Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c.
PFS at BSL, Weeks 1, 2, and 3, followed by administration every four weeks starting
at Week 4
• Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL)
s.c. PFS at BSL, followed by administration every four weeks starting at Week 4
• Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, 4, 8, and 12,
followed by secukinumab 150 mg (1 mL, 150 mg/mL) administration every four
weeks starting at Week 16
Keywords
Spondyloarthritis, Antikörpertherapie
Brief description/objective
A randomized, double-blind, placebo-controlled, phase III
multicenter study of subcutaneous secukinumab (150 mg)
with and without a subcutaneous loading regimen to
assess efficacy, safety, and tolerability up to 2 years in
patients with active ankylosing spondylitis