Phase 3
N=304
AScalate: Treat-to-target in Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03906136 ↗Enrolled (actual)
304
Serious AEs
5.2%
Results posted
Apr 2025
Primary outcome: Primary: Percentage of Patients Achieving an ASAS40 Response at Week 24 — 40.1; 49.2 Percentage of participants — p=0.119
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab/Adalimumab-Biosimilar (Biological); Standard-of-care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving an ASAS40 Response at Week 24 |
40.1; 49.2 | 0.119 |
| SECONDARY Percentage of Patients Achieving an ASAS40 Response at Week 12 |
34.0; 46.6 | 0.029 sig |
| SECONDARY Percentage of Patients Achieving ASAS20 Response |
51.8; 60.1; 62.1; 65.3 | 0.154 |
| SECONDARY Percentage of Patients Achieving ASAS Partial Remission |
18.2; 29.0; 22.8; 28.5 | 0.029 sig |
| SECONDARY Percentage of Patients Meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) Definition of Inactive Disease |
19.8; 33.3; 18.8; 33.0 | 0.008 sig |
| SECONDARY Percentage of Patients With ASDAS Major Improvement |
19.8; 25.6; 18.6; 27.1 | 0.263 |
| SECONDARY Percentage of Patients With ASDAS Low Disease Activity |
46.5; 57.7; 52.4; 57.2 | 0.055 |
| SECONDARY Percentage of Patients Achieving the Bath Ankylosing Spondylitis Disease Activity Index Response 50% (BASDAI 50) at Week 12 and Week 24 |
38.0; 42.0; 42.5; 42.2 | 0.477 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-1.69; -1.99; -1.97; -2.33 | 0.205 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) |
-0.32; -0.38; -0.41; -0.35 | 0.525 |
| SECONDARY Change From Baseline in Chest Expansion |
0.46; 1.35; 0.47; 0.57 | 0.220 |
| SECONDARY Change From Baseline in the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) |
-3.52; -3.39; -4.21; -3.84 | 0.768 |
| SECONDARY Change From Baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index) |
-2.55; -2.81; -3.24; -3.07 | 0.477 |
| SECONDARY Change From Baseline in Global Disease Assessment (Patient) |
-2.95; -3.12; -3.27; -3.48 | 0.586 |
| SECONDARY Change From Baseline in Global Disease Assessment (Physician) |
-32.46; -36.96; -35.81; -38.54 | 0.082 |
Summary
This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was superior to a SOC approach in terms of achieving strong clinical efficacy in patients with active axSpA who were naïve to biological therapy and who had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Axial Spondyloarthritis, axSpA (either Non-Radiographic Axial Spondyloarthritis or Radiographic Axial Spondyloarthritis) fulfilling the Ankylosing Spondyloarthritis International Society classification criteria for axSpA
- Active disease as defined by having an Ankylosing Spondylitis Disease Activity Score ≥ 2.1 at Screening and Baseline despite concurrent Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy, or intolerance/contraindication to NSAIDs.
- Objective signs of inflammation at Screening as defined by: Magnetic Resonance Imaging (MRI) of sacroiliac joints performed up to 3 months prior to screening showing acute inflammatory lesion(s), OR elevated quick C-reactive Protein (CRP) (> 5 mg/L), OR MRI showing acute inflammatory lesion(s) in the sacroiliac joints and spine performed during screening period.
- Inadequate response to NSAIDs
Exclusion Criteria
- Previous exposure to secukinumab or other biologic drug directly targeting Interleukin(IL)-17 or IL-17 receptor.
- Patients who have previously been treated with Tumor Necrosis Factor Alpha inhibitors (investigational or approved).
- Patients treated with any cell-depleting therapies.
- Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunosuppressed the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy.
- History of clinically significant liver disease or liver injury
- History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).
- Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis (TB) infection
- Patients positive for human immunodeficiency virus, hepatitis B or hepatitis C
- Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03906136). 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.