Phase 3
N=859
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT03259074 ↗Enrolled (actual)
859
Serious AEs
11.8%
Results posted
Mar 2023
Primary outcome: Primary: Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) — 66.1; 66.9; 65.6 Percentage of participants — p=0.7164
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Biological); GP2017 (adalimumab biosimilar) (Biological); AIN457 150 mg (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) |
66.1; 66.9; 65.6 | 0.7164 |
| SECONDARY Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) |
0.54; 0.55; 0.72 | — |
| SECONDARY Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) |
56.9; 53.8; 53.3 | — |
| SECONDARY Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) |
-1.527; -1.378; -1.710 | — |
| SECONDARY Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) |
-1.224; -1.683; -2.101 | — |
| SECONDARY Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) |
83.1; 82.9 | — |
| SECONDARY Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) |
69.9; 73.5 | — |
| SECONDARY Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) |
31.5; 30.2 | — |
| SECONDARY Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) |
31.1; 31.7 | — |
Summary
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-nursing female patients at least 18 years of age
- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
- Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
- Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
- hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray
Exclusion Criteria
- Patients with total ankylosis of the spine
- Pregnant or nursing (lactating) women
- Evidence of ongoing infectious or malignant process
- Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
- Subjects taking high potency opioid analgesics
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03259074). 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.