CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 859 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
AIN457 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03259074
NCT03259074Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Aug 23, 2017·Updated Aug 21, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo, GP2017 (adalimumab biosimilar), and 1 other intervention for Ankylosing Spondylitis. Completed, enrolled 859 participants across 171 sites in 29 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 23, 2017
Enrollment StartNov 30, 2017
Primary CompletionNov 12, 2021
Study CompletionNov 29, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.9 years ago

Interventions

Placebobiological

Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes

GP2017 (adalimumab biosimilar)biological

40 mg in pre-filled syringes was administered subcutaneously

AIN457 150 mgbiological

150 mg in pre-filled syringes was administered subcutaneously