Phase 4
N=211
Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT02763046 ↗Enrolled (actual)
211
Serious AEs
2.4%
Results posted
Oct 2020
Primary outcome: Primary: Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12 — 72; 31 Participants — p=0.3512
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Secukinumab (AIN457) 150 mg s.c. (Drug); Placebo - Secukinumab (AIN457) 150 mg s.c. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12 |
72; 31 | 0.3512 |
| SECONDARY Proportion of Patients Who Achieved ASAS20 Response in Each Secukinumab Group (Delayed NSAID Tapering and Early NSAID Tapering) Compared With the Placebo Group |
37; 35; 31; 40; 35; 29 | 0.4010 |
| SECONDARY Mean Change From Baseline in ASAS-NSAID Score at Week 12 |
-44.9; -40.3; -31.5; -42.6 | 0.0997 |
| SECONDARY Mean Change From Baseline in ASAS-NSAID Score in Each Secukinumab Group After 12 Weeks of Exposure (at Week 12 in the Secukinumab-delayed NSAID Tapering Group and at Week 16 in the Secukinumab-early NSAID Tapering Group) |
-44.9; -42.5 | 0.7735 |
| SECONDARY Mean Change From Baseline in the BASDAI Total Score |
-2.1; -2.0; -1.8; -2.1; -2.3; -2.0 | 0.1926 |
| SECONDARY Mean Change From Baseline in Health-related Quality of Life as Measured by the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score |
4.8; 6.1; 4.8; 5.5 | 0.5384 |
Summary
This study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to secukinumab and evaluated to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab or placebo following an initial run-in phase of stable NSAID therapy.
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of active AS with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
- Active AS assessed by total BASDAI ≥ 4 (0-10) at baseline
- Spinal pain as measured by BASDAI Question 2 ≥ 4 cm on a 0-10 cm numeric rating scale at baseline
- Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline
- Patients should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks prior to randomization, with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications
- Patients must report regular intake of NSAIDs of at least 50% of the highest recommended dose at Screening.
- Patients with prior TNFα inhibitor therapy must report regular intake of NSAIDs of at least 50% of the highest recommended dose at baseline after the appropriate washout
- Patients are required to be on a stable dose of NSAIDs for at least 2 weeks before randomization
- Patients who have previously been on a TNFα inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization
- Patients who have been on a TNFα inhibitor (not more than two) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent.
- Patients taking MTX or sulfasalazine are allowed to continue their medication and must have taken it for at least 3 months and be on a stable dose for at least 4 weeks prior to randomization
Key Exclusion Criteria
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process.
- Previous exposure to Secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- Patients previously treated with any biological immunomodulating agents, except those targeting TNFα
- Patients who have taken more than two anti-TNFα agents
- Pregnant or nursing (lactating) women.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
- Patients who are intolerant to NSAIDs
Data sourced from ClinicalTrials.gov (NCT02763046). 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.