16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis

Phase 1

• Conditions: Ankylosing Spondylitis; MedDRA version: 18.1Level: LLTClassification code 10002555Term: Ankles swollenSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-005575-41-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-11
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

- Moderate to severe AS
- Prior radiographic evidence according to the Modified NY Criteria (1984)
- Inadequate response to NSAIDs
Other protocol-definied 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 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Pregnancy or lactation
- On-going 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-definied exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified