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Clinical Trials/EUCTR2013-001090-24-DE
EUCTR2013-001090-24-DE
Active, not recruiting
Phase 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 enrollmentOctober 24, 2013
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ConditionsAnkylosing spondylitisMedDRA version: 18.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Ankylosing spondylitis
Sponsor
ovartis Pharma Services AG
Enrollment
222
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 24, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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