16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis (MEASURE4)

Novartis

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Biological: Placebo; Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02159053

CAIN457F2320

2013-005575-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.

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-defined inclusion/exclusion criteria do apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

350 participants in 3 patient groups, including a placebo group

Secukinumab 150 mg s.c. with loading

Experimental group

Description:

Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

Treatment:

Biological: Secukinumab

Biological: Secukinumab

Secukinumab 150 mg s.c. without loading

Experimental group

Description:

Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3.

Treatment:

Biological: Secukinumab

Biological: Secukinumab

Placebo

Placebo Comparator group

Description:

Placebo at Baseline, Weeks 1, 2, 3, 4, 8, and 12, followed by dosing with Secukinumab 150 mg every four weeks starting at Week 16.

Treatment:

Biological: Placebo