Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
AIN457 Phase 3 clinical trial
A clinical trial for patients with Ankylosing Spondylitis (AS) or non-radiographic Axial Spondyloarthritis (nr-axSpA), to receive study treatment using an intravenous (IV) form of secukinumab, instead of a subcutaneous injectable.
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis. Phase III clinical study.
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ClinicalTrials.gov Identifier: NCT04156620 | Novartis reference number: CAIN457P12301 | Last updated on: July 24, 2020
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.
Why should I participate in this clinical trial?
If living with AS or nr-axSpA is causing you constant pain and disrupting your life, even with current treatment, this trial may be the first step towards helping find a treatment for the long-term relief you deserve.
If you or someone you care about is living with AS or nr-axSpA, Novartis invites you to take part in a new clinical trial for an IV form of secukinumab. To potentially help patients get faster and longer-lasting relief from this condition, we are looking for people who have been diagnosed with AS or nr-axSpA to participate in the development and delivery of this new medicine. We are seeking 500 participants globally, 90 in the United States.
We are working to develop an IV version of the medicine that might:
- Make treatment easier and more effective for patients with weight issues and co-occurring conditions
- Offer faster relief from inflammatory pain and symptoms through direct IV administration
- Provide an alternative for patients that don't like needles, and patients with advanced disease that struggle to inject themselves
To learn more about participating in a clinical trial, watch our video below:
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Trial purpose
To demonstrate the efficacy, safety, and tolerability of an IV regimen of secukinumab compared to placebo in subjects with active nr-axSpA or AS at Week 16 despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying anti-rheumatic drug (DMARD), and/or anti-tumor necrosis factor (TNF) therapy. In addition, to further support efficacy and safety of an IV regimen, data will be collected for up to 52 weeks of treatment. Efficacy and safety data may also be used to support the registration of IV secukinumab in the United States and other countries for treatment of subjects with active axSpA.
CONDITION
Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
PHASE
Phase III
STUDY TYPE
Interventional
GENDER(S)
All
AGE(S)
18 Years and Older (Adult, Older Adult)
ACCEPTS HEALTHY VOLUNTEERS
No
ACTUAL START DATE
December 11, 2019
ESTIMATED COMPLETION DATE
February, 2023
ESTIMATED ENROLLMENT
500 Participants
RECRUITMENT STATUS
Recruiting
Do I qualify?
If you wish to participate in the trial, you must meet the following requirements:
- Male or non-pregnant, non-lactating females over 18 years of age
- Diagnosed with AS or nr-axSpA
- Ability to give written, signed, and dated informed consent before any study assessment is performed
- No serious and unmanaged pre-existing medical conditions
- No active use of opioid painkillers
Your doctor can also help you to determine if you qualify by performing the required diagnostic tests.
For a complete list of inclusion and exclusion criteria, please click here.
How long is the study?
This study will consist of 4 periods totalling up to 70 weeks:
- Screening period (up to 10 weeks)
- Treatment period 1 (total duration of 16 weeks)
- Treatment period 2 (total duration of 36 weeks)
- Safety follow-up period of 8 weeks after the end of last treatment visit
You will not be charged for participation or early exit from the trial and can drop out at any time.
What type of treatment will I get during the trial?
The primary purpose of the study is to examine the trial medicine’s effectiveness vs a placebo. You will be placed in 1 of 2 groups at random, which will determine the type of study treatment you receive.
- Group 1: will be treated with 6 mg/kg of body weight of IV secukinumab during their initial visit (6 mg/kg at baseline), followed by 3 mg/kg of IV secukinumab every 4 weeks (3 mg/kg q4w) starting at week 4 through week 48.
- Group 2: will be treated with IV placebo during their initial visit and at weeks 4, 8, and 12, followed by 3 mg/kg q4w of IV secukinumab at week 16 and every 4 weeks through week 48.
You will not be treated with a placebo beyond week 16 if you’re randomized for Group 2.
How do I sign up?
To see if you qualify for the study, fill out the pre-screener here and a study representative may contact you. We encourage you to speak with your doctor before completing the questionnaire. You may be referred to a trial location near you, where a physical exam will be performed before determining your eligibility for the trial. If you find that you’re not qualified to participate in the trial, we encourage you to work with your doctor to find other options for AS or nr-axSpA symptom relief.
What medicine do I receive?
Drug: Secukinumab
or
Drug: Placebo