AScalate: Treat-to-target in Axial Spondyloarthritis

A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

ClinicalTrials.gov Identifier: NCT03906136

Novartis Reference Number: CAIN457HDE01

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are naïve to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

Condition 
Axial Spondyloarthritis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
300 participants
Start date 
Jun 04, 2019
Completion date 
Jun 22, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Secukinumab/Adalimumab-Biosimilar
Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab-Biosimilar, s.c.
Other
Standard-of-care
Patients will receive treatment according to local practice standards by their treating physician following the current treatment recommendations.

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.

Study Locations

France
Novartis Investigative Site
Recruiting
Orleans, 45067
Cedex 2
France
Novartis Investigative Site
Recruiting
Nice, 06001
Cedex1
France
Novartis Investigative Site
Recruiting
Limoges cedex, 87000
Haute Vienne
France
Novartis Investigative Site
Recruiting
Caluire et Cuire, 69300
-
France
Novartis Investigative Site
Recruiting
Chambray-lès-Tours, 37170
-
France
Novartis Investigative Site
Recruiting
Grenoble Cedex,
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France
Novartis Investigative Site
Recruiting
La Roche sur Yon, 85925
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France
Novartis Investigative Site
Recruiting
Le Mans, 72037
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France
Novartis Investigative Site
Recruiting
Montpellier Cedex 5, 34295
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France
Novartis Investigative Site
Recruiting
Nantes, 44000
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex, 31059
-
France
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy, 54511
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France
Germany
Novartis Investigative Site
Recruiting
Bad Abbach, 93077
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Germany
Novartis Investigative Site
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Bad Doberan, 18209
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Germany
Novartis Investigative Site
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Bad Pyrmont, 31812
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Germany
Novartis Investigative Site
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Berlin, 12161
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Germany
Novartis Investigative Site
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Berlin, 12163
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Germany
Novartis Investigative Site
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Berlin, 13125
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Germany
Novartis Investigative Site
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Berlin, 13353
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Germany
Novartis Investigative Site
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Berlin, 14059
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Germany
Novartis Investigative Site
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Bonn, 53105
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Germany
Novartis Investigative Site
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Chemnitz, 09130
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Germany
Novartis Investigative Site
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Cottbus, 03042
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Germany
Novartis Investigative Site
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Dresden, 01067
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Germany
Novartis Investigative Site
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Dresden, 01307
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Germany
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Ehringshausen, 35630
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Germany
Novartis Investigative Site
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Erfurt, 99096
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Germany
Novartis Investigative Site
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Erlangen, 91056
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Germany
Novartis Investigative Site
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Freiberg, 09599
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Germany
Novartis Investigative Site
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Freiburg, 79106
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Germany
Novartis Investigative Site
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Gommern, 39245
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Germany
Novartis Investigative Site
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Hamburg, 20095
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Germany
Novartis Investigative Site
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Hamburg, 22391
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Germany
Novartis Investigative Site
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Hamburg, 22415
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Germany
Novartis Investigative Site
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Herne, 44649
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Germany
Novartis Investigative Site
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Hildesheim, 31134
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Germany
Novartis Investigative Site
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Langenau, 89129
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Germany
Novartis Investigative Site
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Magdeburg, 39104
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Germany
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Magdeburg, 39110
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Germany
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Mainz, 55131
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Germany
Novartis Investigative Site
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Muenchen, 80333
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Germany
Novartis Investigative Site
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Muenchen, 80639
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Germany
Novartis Investigative Site
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Muenchen, 81377
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Germany
Novartis Investigative Site
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Ratingen, 40878
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Germany
Novartis Investigative Site
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Rendsburg, 24768
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Germany
Novartis Investigative Site
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Trier, 54292
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Germany
Novartis Investigative Site
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Ulm, 89073
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Germany
Novartis Investigative Site
Recruiting
Winsen/Luhe, 21423
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

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