Phase 3 Ankylosing Spondylitis Trial, Completed NCT02159053 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 (NCT02159053) enrolled 350 people in total across three groups: 116 received secukinumab 150 mg with a "loading dose" (extra doses at the start), 117 received secukinumab 150 mg without a loading dose, and 117 received a placebo (an inactive treatment). The trial was measuring how people with ankylosing spondylitis — a type of inflammatory spinal condition — responded to the medication compared to placebo, using a range of standardised questionnaires and blood tests over 16 weeks. The reported data shows that for the main outcome — the proportion of participants who met a standard set of improvement criteria across four areas (overall disease activity, back pain, physical function, and morning stiffness) — 60.5% in the loading-dose group, 65.5% in the no-loading-dose group, and 49.1% in the placebo group reached that threshold at 16 weeks. For a stricter version of those same criteria (requiring greater improvement), the reported figures were 39.5%, 38.2%, and 29.5% respectively. A blood marker linked to inflammation (high-sensitivity C-reactive protein) showed reported average changes of −4.23 and −6.57 (in ratio units) for the two secukinumab groups, compared to +0.62 for the placebo group. On a disease activity score (rated 0–10, where higher means worse), the reported average reductions from starting scores were approximately 2.4 and 2.5 points for the secukinumab groups, and 1.9 points for the placebo group. A physical quality-of-life score (where higher numbers mean less disability) showed reported average increases of about 6.8 and 7.2 points in the secukinumab groups, and 4.7 points in the placebo group. 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

NCT02159053
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 have been diagnosed with moderate to severe ankylosing spondylitis (a type of inflammatory spinal arthritis)
  • Past X-rays have confirmed your diagnosis based on specific medical imaging guidelines from 1984 (confirm with trial site)
  • Pain relief medications known as NSAIDs (such as ibuprofen or naproxen) have not worked well enough to control your symptoms

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • A chest X-ray or MRI scan shows signs of an active infection or cancer
  • You have previously been treated with certain targeted therapies that affect a protein called IL-17 or its receptor (confirm with trial site)
  • You have previously used any biological medication that affects the immune system, with the exception of TNF blocker treatments (a specific type of immune therapy)
  • You have previously had a treatment designed to remove or reduce certain immune cells from your body (confirm with trial site)

Please note that there are additional eligibility requirements beyond those listed here that the trial team will also need to check.

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

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Kogarah, New South Wales
Novartis Investigative Site, Maroochydore, Queensland
Novartis Investigative Site, Hobart, Tasmania
Novartis Investigative Site, Malvern East, Victoria

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
18 May 2015
Est. completion
23 February 2016

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇷🇺 Russia 🇸🇰 Slovakia 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks

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