16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients (MEASURE 3)

Novartis

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Drug: Secukinumab; Drug: Placebo secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02008916

2013-001090-24 (EudraCT Number)

CAIN457F2314

Details and patient eligibility

About

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Enrollment: 226 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 3 patient groups, including a placebo group

Secukinumab 10 mg/kg i.v. / 300 mg s.c.

Experimental group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Treatment:

Drug: Secukinumab

Secukinumab 10 mg/kg i.v. / 150 mg s.c.

Experimental group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Treatment:

Drug: Secukinumab

Placebo i.v. and s.c.

Placebo Comparator group

Description:

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Treatment:

Drug: Placebo secukinumab