Novartis has started a new head-to-head clinical trial of Cosentyx (secukinumab) in comparison with proposed biosimilar adalimumab to treat ankylosing spondylitis (AS).
The SURPASS trial aims to evaluate the superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab, which includes a development compound from Sandoz.
SURPASS is currently enrolling patients and has achieved ‘first patient first visit’ in November last year.
The randomised, controlled trial features a one year, parallel-group study with three treatment arms, including Cosentyx 150mg subcutaneously (sc), Cosentyx 300mg sc and proposed biosimilar adalimumab 40mg sc in patients with active AS.
The trial’s primary endpoint is the proportion of patients with no spinal radiographic structural progression, defined as a change from baseline of =<0.5 in Stoke Ankylosing Spondylitis Spinal Score (mSASSS) at two years.
Major secondary endpoints include a mean change in mSASSS, new syndesmophyte formation, and MRI measures of inflammation, also at two years.
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In addition, Novartis has started the EXCEED trial, which is the first head-to-head superiority trial assessing Humira (adalimumab) in comparison with Cosentyx for the treatment of psoriatic arthritis.
The one-year, multi-centre, randomised, double-blind, active control, Phase IIIb study is designed to assess the efficacy of Cosentyx monotherapy compared with Humira monotherapy in patients with active PsA who are naïve to biologic therapy.
The trial seeks to enrol more than 800 biologic-naïve patients with PsA.
Its primary object will evaluate the statistical superiority of Cosentyx monotherapy against adalimumab monotherapy for ACR 20 response rates at one year.
Secondary endpoints of the trial include PASI 90, ACR 50, disability index (HAQ-DI score) relative to baseline, and resolution of enthesitis.