Phase 3 Ankylosing Spondylitis Trial, Completed NCT02696031 Sponsor: Novartis Pharmaceuticals Condition: Ankylosing Spondylitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02696031) enrolled 555 adults across three groups in its main phase: 185 received secukinumab with a loading dose schedule, 184 received secukinumab without a loading dose, and 186 received a placebo (an inactive treatment). A further 372 participants continued into a longer extension phase lasting up to around four years. The trial was measuring responses in people with ankylosing spondylitis (a type of inflammatory spinal condition) using a standard scoring system called ASAS — a set of measures that tracks things like back pain, physical function, morning stiffness, and spinal movement. The main question the trial asked was how many participants showed a meaningful improvement (called an "ASAS40 response," meaning at least a 40% improvement across most of those areas) at weeks 16 and 52, focusing on participants who had not previously tried a class of medicines called TNF inhibitors. The reported data shows that at week 16, 68 out of 185 participants (roughly 37%) in the secukinumab loading-dose group and 70 out of 184 (roughly 38%) in the no-loading-dose group met the ASAS40 threshold, compared with 50 out of 186 (roughly 27%) in the placebo group. At week 52, those numbers were 58 (about 31%) and 66 (about 36%) in the two secukinumab groups, versus 34 (about 18%) in the placebo group. For the secondary measures — which looked at all participants, not just those who hadn't previously used TNF inhibitors — the reported data shows similar patterns across the different response thresholds tested (ASAS20, ASAS40, ASAS 5/6, and partial remission), with the secukinumab groups consistently reporting higher numbers of participants meeting each threshold compared with the placebo group. For example, 40–39 participants in the secukinumab groups versus 13 in the placebo group were reported to meet the "partial remission" criterion at week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Ankylosing Spondylitis Trial, Completed

NCT02696031
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male, or a female who is not pregnant and not breastfeeding, and you are at least 18 years old
  • You have been diagnosed with axial spondyloarthritis (a type of inflammatory arthritis affecting the spine) based on recognised international diagnostic standards
  • Your condition shows objective signs of inflammation, either seen on an MRI scan or through an abnormal blood test result (C-reactive protein)
  • Your disease is considered active, based on a standard disease activity scoring tool called the BASDAI, with a score of 4 or higher
  • You have significant spinal pain, scoring at least 4 out of 10 on a standard pain questionnaire
  • Your overall back pain scores at least 40 out of 100 on a pain scale measured at the start of the trial
  • You have already tried at least 2 different anti-inflammatory painkiller medications (such as ibuprofen or naproxen) without enough improvement
  • If you have previously used a specific type of medication called a TNF inhibitor, you must have tried only one and found it did not work well enough

Who may not be able to join:

  • Your X-rays show significant damage to the joints where your spine meets your pelvis (sacroiliac joints), at a certain level of severity (confirm with trial site)
  • You are unable or unwilling to have an MRI scan
  • Your chest X-ray or MRI shows signs of an active infection or cancer
  • You are currently taking strong opioid painkillers (such as morphine or oxycodone)
  • You have previously been treated with the drug secukinumab or any other medication that targets a substance in the body called interleukin-17 (IL-17)
  • You are pregnant or currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Novartis Investigative Site, Coffs Harbour, New South Wales
Novartis Investigative Site, Maroochydore, Queensland
Novartis Investigative Site, Hobart, Tasmania
Novartis Investigative Site, Malvern East, Victoria
Novartis Investigative Site, Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
29 April 2016
Est. completion
1 July 2019

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16; The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov