Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02750592
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
• Scientific title: An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
• Date of first enrolment: March 22, 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02750592
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or
radiologist's report) fulfilling the Modified New York criteria for AS with active AS
assessed by BASDAI = 4 (0-10) and spinal pain as measured by VAS= 4 cm (BASDAI
question #2) at Baseline

- Patients should have been on NSAIDs at the highest recommended dose for at least 3
months prior to baseline with an inadequate response or failure to respond, or less
than 3 months if therapy had to be withdrawn due to intolerance, toxicity or
contraindications

- Patients who have been on a TNFa inhibitor (not more than one) must have experienced
an inadequate response to previous or current treatment given at an approved dose for
at least 3 months prior to baseline or have been intolerant to at least one
administration of an anti-TNFa agent

Exclusion Criteria:

- Patients with total ankylosis of the spine

- Patients previously treated with any biological immunomodulating agents except for
those targeting TNFa

- Active ongoing inflammatory diseases other than AS that might confound the evaluation
of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis

- Known infection with HIV, hepatitis B or hepatitis C at screening or baseline



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

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.

Primary Outcome(s)

Assessment of SpondyloArthritis International Society 20 Response (ASAS20) [Time Frame: week 16]

Secondary Outcome(s)

Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate [Time Frame: Week 16]

Participants With Newly Occurring Notable Abnormalities in Vital Signs [Time Frame: week 60]

Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score [Time Frame: Baseline, week 16]

Change in High Sensitivity C-Reactive Protein (hsCRP) [Time Frame: baseline, Week 16]

Change in Serum Concentration of Secukinumab [Time Frame: Baseline, weeks 4, 16, 24, 52, 60]

Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities [Time Frame: week 60]

Proportion of Participants Achieving ASAS Partial Remission [Time Frame: week 16]

Mean Change From Baseline in BASDAI From Baseline [Time Frame: Baseline, week 16]

ASAS 40 Response Rate With Non-responder Imputation (NRI) [Time Frame: Week 16]

Number of Participants With ASAS 5/6 Response Criteria [Time Frame: Week 16]

Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood [Time Frame: week 60]

Number of Participants With Immunogenicity Against Secukinumab [Time Frame: week 60]

Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade [Time Frame: week 60]

Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score [Time Frame: Baseline, week 16]

Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities [Time Frame: week 60]

Secondary ID(s)

CAIN457H1301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02750592