Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis

Phase 1

• Conditions: non-radiographic axial spondyloarthritis; MedDRA version: 18.1Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-001106-33-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-18
• Study Completion: 2021-03-11
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

- Male or non-pregnant, non-nursing female patients at least 18 years of age
- Diagnosis of axSpA according to ASAS axSpA criteria
- Objective signs of inflammation (MRI or abnormal CRP)
- Active axSpA as assessed by total BASDAI >/=4 cm
- Spinal pain as measured by BASDAI question n.2 >/= 4 cm (0-10 cm) at baseline
- Total back pain as measured by VAS >/= 40 mm (0-100 mm) at baseline
- Patients should have been on at least 2 different NSAIDs with an inadequate response
- Patients who have been on a TNF alpha inhibitor (not more than one) must have experienced an inadequate response
- 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 505
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Patients with radiographic evidence for sacroiliitis, grade >/= 2 bilaterally or grade >/= 3 unilaterally
- Inability or unwillingness to undergo MRI
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process
- Patients taking high potency opioid analgesics
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- Pregnant or nursing (lactating) women
- Other protocol-defined exclusion criteria may apply

Study & Design

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