Phase 4
Completed N=322
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT03350815 ↗
Enrolled (actual)
322
Serious AEs
3.8%
Results posted
Apr 2022
Primary outcomePrimary: The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure — 9; 7 Participants
◆ Published Evidence
Emerging
3citations · ~3 / year
A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment.
Summary
This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
Linked Publications
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A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure |
9; 7 | — |
| SECONDARY The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale |
6; 3 | — |
| SECONDARY Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
0.18; -0.05 | — |
| SECONDARY Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50) |
11; 9 | — |
| SECONDARY The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) |
19; 22 | — |
| SECONDARY The Proportion of Participants Who Achieved an ASAS 40 Response |
10; 8 | — |
| SECONDARY The Proportion of Patients Who Achieved an ASAS Partial Remission |
12; 12 | — |
| SECONDARY Change in ASAS - Health Index Over Time |
0.51; 0.38 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time |
-1.93; -0.92 | — |
Eligibility Criteria
Key Inclusion Criteria
- Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
- Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline
- Patients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications
- Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit
- Patients who have been on a tumor necrosis factor alpha (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 had been intolerant upon administration of an anti-TNFα agent
Key Exclusion Criteria
- Total ankylosis of the spine
- Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
- Previous exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFα
- Patients who have taken more than one anti-TNFα agent
- Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
- Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline
- Previous treatment with any cell-depleting therapies
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03350815) and the linked publication. 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.