A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis

A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44029

Enrollment

Registered

2016-07-18

Start date

2015-06-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bechterew disease

Interventions

Treatment: Secukinumab or placebo.

ankylosing spondylitis

placebo

secukinumab

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Moderate to severe AS - Prior radiographic evidence according to the Modified NY Criteria (1984) - Inadequate response to NSAIDs;See protocol for other inclusion criteria.

Exclusion criteria

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;See protocol for other exclusion criteria.

Design outcomes

Primary

Measure	Time frame
ASAS20	—

Secondary

Measure	Time frame
ASAS20, ASAS40, adverse events.	—

Countries

Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Switzerland, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)