A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
- Conditions
- Non-radiographic Axial Spondyloarthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05622708
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP \< 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
- Detailed Description
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP \< 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
Study treatment will be as follows:
* Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL
* Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo.
Study duration will be up to 128 weeks from Baseline.
The treatment duration will be up to 120 weeks with last treatment administration at Week 116.
In the Treatment Period 1 participant will attend a site visit approximately 1 month after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2 participant will attend site visits approximately every 4 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
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Male or non-pregnant, non-lactating female participants at least 18 years of age
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Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
- Inflammatory back pain for at least 6 months
- Onset before 45 years of age
- Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
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Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined by the central lab)
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Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
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Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
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Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline.
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Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
- Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader.
- Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed).
- History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes.
- Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis.
- Active inflammatory bowel disease.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Period 2 Placebo Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo Treatment Period 1 Secukinumab Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL Treatment Period 2 Secukinumab Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
- Primary Outcome Measures
Name Time Method The proportion of participants remaining flare-free during Treatment Period 2 Week 120 The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP \> 3.5 at any visit during Treatment Period 2, starting at Week 60.
Parameters used for ASDAS-CRP include:
* Spinal pain (BASDAI question 2),
* Patient's global assessment of disease activity,
* Peripheral pain/swelling (BASDAI question 3),
* Duration of morning stiffness (BASDAI question 6)
* C-reactive protein (CRP) in mg/L
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events From Baseline to Week 128 Safety and tolerability demonstrated by assessing:
- Adverse events (AEs) and serious adverse events (SAEs)Time to flare during Treatment Period 2 From Week 56 to Week 120 A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP \> 3.5 at any visit during Treatment Period 2, starting at Week 60.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇻🇳Ho Chi Minh, Vietnam