NCT03259074

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 859 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

Detailed description

This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120). Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120). A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia. .

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
BIOLOGICAL	GP2017 (adalimumab biosimilar)	40 mg in pre-filled syringes was administered subcutaneously
BIOLOGICAL	AIN457 150 mg	150 mg in pre-filled syringes was administered subcutaneously

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-11-12
• Completion: 2021-11-29
• First posted: 2017-08-23
• Last updated: 2023-08-21
• Results posted: 2023-03-09

Locations

171 sites across 29 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Japan, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study