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

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

Last update

Jul 24, 2020

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.