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Phase 4 Completed N=322 Randomized Double-blind Treatment

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.
Rheumatology (Oxford, England) · 2025 · Open access · Likely link

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

  • A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment.
    Rheumatology (Oxford, England) · 2025 · 3 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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.

View full record on ClinicalTrials.gov →

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.

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