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 (NCT03259074) enrolled 859 people with ankylosing spondylitis (a type of inflammatory spinal condition). Participants were divided into three groups: one received a lower dose of the study drug AIN457 (150 mg) for part of the study then switched to placebo, one received a higher dose of AIN457 (300 mg) throughout, and one received a comparator medicine called GP2017 (40 mg). The trial ran for approximately two years (104 weeks) and its main focus was measuring whether participants' spines showed changes on X-ray over that time. The reported data shows that, for the primary outcome — the proportion of participants whose X-ray spine scores did not worsen beyond a small threshold over two years — results were similar across all three groups: approximately 66% in the lower-dose AIN457 group, 67% in the higher-dose AIN457 group, and 66% in the GP2017 group. For the secondary outcomes, the reported average change in the X-ray spine score from the start to two years was small and similar across groups (around 0.54–0.72 points on a scale of 0–72). Among participants who already had certain bony growths on the spine at the start, roughly 54–57% across all groups had no new such growths at two years. MRI scans (a type of detailed imaging) measuring inflammation in the spine and pelvis showed small reductions in inflammation scores across all groups. Finally, in the two AIN457 groups only, around 83% of participants in each group met a standard measure of symptom improvement (at least a 20% improvement across key areas such as pain and function). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 33978600) ↗
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
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 or breastfeeding, and you are at least 18 years old
- You have been diagnosed with moderate to severe Ankylosing Spondylitis (a type of spinal arthritis) confirmed by X-ray, and standard anti-inflammatory or non-biologic medications have not fully helped
- Your Ankylosing Spondylitis is currently active, scoring at least 4 out of 10 on a standard disease activity questionnaire (called BASDAI)
- Your spinal pain scores at least 4 out of 10 on a specific question within that same questionnaire
- Your overall back pain rates at least 40 out of 100 on a pain scale
- Your blood shows raised inflammation levels (CRP ≥ 5 mg/L), OR your X-ray shows at least one bony growth on your spine (confirm with trial site)
Who may not be able to join:
- Your spine is completely fused/locked in place (total ankylosis)
- You are pregnant or currently breastfeeding
- You have an active infection or any ongoing cancer or malignant condition
- You have previously been treated with any biologic medicines, including those targeting IL-17, IL-17 receptor, or TNF-alpha (common biologics used for arthritis)
- You are currently taking strong opioid painkiller medications
- You have previously had treatments that deplete certain immune cells, such as anti-CD20 therapies or certain experimental treatments (confirm with trial site)
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.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.