Phase 3
Completed N=30
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT02750592 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Sep 2019
Primary outcomePrimary: Assessment of SpondyloArthritis International Society 20 Response (ASAS20) — 21 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of SpondyloArthritis International Society 20 Response (ASAS20) |
21 | — |
| SECONDARY ASAS 40 Response Rate With Non-responder Imputation (NRI) |
14 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate |
11 | — |
| SECONDARY Change in High Sensitivity C-Reactive Protein (hsCRP) |
0.247 | — |
| SECONDARY Number of Participants With ASAS 5/6 Response Criteria |
14 | — |
| SECONDARY Mean Change From Baseline in BASDAI From Baseline |
-3.088 | — |
| SECONDARY Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score |
6.306 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score |
-3.40 | — |
| SECONDARY Proportion of Participants Achieving ASAS Partial Remission |
6 | — |
| SECONDARY Change in Serum Concentration of Secukinumab |
51.3; 25.0; 22.2; 21.1; 6.2 | — |
| SECONDARY Number of Participants With Immunogenicity Against Secukinumab |
— | — |
| SECONDARY Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood |
6; 0; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade |
3; 0; 0; 0; 3; 0 | — |
| SECONDARY Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities |
5; 1; 1; 0; 0; 4 | — |
| SECONDARY Participants With Newly Occurring Notable Abnormalities in Vital Signs |
2; 5; 0; 8; 5; 0 | — |
Eligibility 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 TNFα 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-TNFα agent
Exclusion Criteria
- Patients with total ankylosis of the spine
- Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
- 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
Data sourced from ClinicalTrials.gov (NCT02750592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.