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Clinical Trials/EUCTR2013-001090-24-DE
EUCTR2013-001090-24-DEActive, not recruitingPhase 1

A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis

ovartis Pharma Services AG0 sites222 target enrollmentStarted: October 24, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
222
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Moderate to severe AS
  • •- Prior radiographic evidence according to the Modified NY Criteria (1984)
  • •- Inadequate response to NSDAIDs
  • •Other protocol-defined inclusion criteria may apply
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 220
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

  • •- Pregnancy or lactation
  • •- Ongoing infectious or malignant process on a chest X-ray or MRI
  • •- Previous exposure to IL-17 or IL-17R targeting therapies
  • •- Previous exposure to any biological immunomodulating agent excluding TNF antagonists
  • •- Previous cell depleting therapy
  • •Other protocol-defined exclusion critera may apply

Investigators

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