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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02159053
• Date of registration: 28/02/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis MEASURE4
• Scientific title: 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
• Date of first enrolment: May 18, 2015
• Target sample size: 350
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02159053
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Biological: Secukinumab

Biological: Placebo

Primary Outcome(s)

Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks [Time Frame: 16 Weeks]

Secondary Outcome(s)

Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks [Time Frame: 104 Weeks]

Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks [Time Frame: Baseline, 16 Weeks]

Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) [Time Frame: Baseline, 16 Weeks]

Percentage of Participants Responded for ASAS 40 Response at 16 Weeks [Time Frame: 16 Weeks]

Percentage of Participants Responded for ASAS 40 Response at Week 4 [Time Frame: Week 4]

Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks [Time Frame: 16 Weeks]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks [Time Frame: Baseline, 16 Weeks]

Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks [Time Frame: Baseline, 16 Weeks]

Percentage of Participants Responded for ASAS 20 at Week 4 [Time Frame: Week 4]

Secondary ID(s)

2013-005575-41

CAIN457F2320

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02159053