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

NCT03259074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 859

Last updated 2023-08-21

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2021-11-12
Completion
2021-11-29
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259074 on ClinicalTrials.gov