Study to Demonstrate the Efficacy Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

  • STATUS
    Recruiting
  • End date
    Feb 13, 2023
  • participants needed
    500
  • sponsor
    Novartis Pharmaceuticals
Updated on 27 August 2021

Summary

The purpose of this global study is to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in subjects with active axSpA at Week 16 despite current or previous NSAID, DMARD and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data will be collected for up to 52 weeks of treatment. Efficacy and safety data may be used to support the registration of i.v. secukinumab in the US and other countries for treatment of subjects with active axSpA.

Description

This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design to study the efficacy, safety, and tolerability of treatment with intravenous secukinumab (initial dose of 6 mg/kg followed thereafter with 3 mg/kg administered every four weeks starting at Week 4) in subjects with active axSpA. The study population consists of approximately 400 subjects with active AS and approximately 100 subjects with active nr-axSpA, despite current or previous NSAID, conventional DMARD and / or TNF inhibitor therapy, or intolerance to these therapies. A screening (SCR) period of up to 10 weeks will be used to assess eligibility, followed by randomization to 52 weeks of study treatment.

At baseline, subjects with active AS and nr-axSpA will be randomized to one of the two treatment groups:

  • Group 1: approximately 200 AS subjects and approximately 50 nr-axSpA subjects; These subjects will receive secukinumab 6 mg/kg i.v. at randomization (Baseline (BSL) visit), followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52).
  • Group 2: approximately 200 AS subjects and approximately 50 nr-axSpA subjects; These subjects will receive i.v. placebo at randomization (BSL visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52).

This study will consist of 4 periods totaling up to 70 weeks: the screening period (up to 10 weeks), the treatment period 1 (total duration of 16 weeks) and the treatment period 2 (total duration of 36 weeks) followed by the safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).

The subjects will be stratified at randomization according to disease condition (i.e., AS or nr-axSpA). No more than 20% TNF Inhibitor Incomplete Responders (TNF-IR) subjects will be enrolled in the study. Starting at Week 16, all subjects will switch to open-label intravenous secukinumab, including all placebo subjects.

No subject will be on placebo treatment after Week 16. Although study treatment is open label secukinumab i.v. starting at Week 16, all subjects and investigators/site staff will remain blinded to original treatment assignment, so as to ensure unbiased efficacy and safety assessments for the remainder of the study. Study treatment will continue up to Week 52. An end of treatment visit (i.e., Week 52) is to be done 4 weeks after last study treatment administration and a post treatment follow-up visit (i.e., Week 60) is to be done 8 weeks after the end of treatment visit for all subjects (regardless of whether they complete the entire study as planned or discontinue prematurely). All i.v. infusions will be performed at the study site and site personnel will administer the infusions to subjects.

Rescue medication is not allowed until Week 16. However, subjects who are deemed by the investigator not to be benefiting from the study treatment based on safety and efficacy assessments or for any reason of their own accord will be free to discontinue participation in the study at any time. The study will have a primary endpoint analysis at Week 16. Therefore, the primary analysis will be performed with Week-16 data once the last subject has completed the Treatment Period 1.

Clinical management of axSpA by pharmacotherapy includes the use of NSAIDs and conventional DMARDs, and if insufficient response, biologic agents (i.e., TNF-inhibitor therapy or anti-IL17 agents).

This study intends to enroll patients with active disease despite current or previous NSAIDs, conventional DMARDs and/or TNF inhibitor therapy or intolerance to these therapies. A background of NSAID therapy and/or concomitant therapy with methotrexate (25 mg/week) or sulfasalazine ( 3 g/day) will be acceptable, if dose and route of administration have been stable for at least two weeks with NSAIDs and/or four weeks with MTX or sulfasalazine, prior to the randomization visit. Inclusion of patients with active axSpA who are TNF-IR (up to 20% in each group) in the study also makes the background patient population more representative of the real world clinical scenario.

A placebo arm up to the primary endpoint at Week 16 is included in this study. Due to the nature of the disease and the outcome measures used (ASAS criteria), a placebo arm is necessary to reliably evaluate the efficacy and safety of the active drug. The treatment duration of the placebo group is relatively short and the placebo group will be re-assigned to active treatment at Week 16. The regular assessment of disease activity ensures that subjects who are experiencing worsening of disease in any of the treatment groups can exit the study at any time upon their own accord or based on the advice of the investigator.

Details
Condition Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Treatment Placebo, Secukinumab
Clinical Study IdentifierNCT04156620
SponsorNovartis Pharmaceuticals
Last Modified on27 August 2021

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