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16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

NCT02159053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-04-10

Study results available
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Summary

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.

Conditions

  • Spondylitis, Ankylosing

Interventions

BIOLOGICAL

Secukinumab

Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

BIOLOGICAL

Secukinumab

Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio

BIOLOGICAL

Placebo

Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-18
Primary Completion
2016-02-23
Completion
2018-01-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT02159053 on ClinicalTrials.gov