Phase 3 Psoriatic Arthritis Trial, Completed NCT01392326 Sponsor: Novartis Pharmaceuticals Condition: Psoriatic Arthritis
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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 (NCT01392326) enrolled 606 people in total — 202 in each of three groups. One group received a 75 mg dose of the study drug (secukinumab, also referred to as AIN457), one received a 150 mg dose, and one received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants showed a meaningful improvement in joint symptoms — specifically, at least a 20% improvement across several standard measures of joint pain, swelling, and overall disease activity (a standard benchmark known as "ACR20"). A number of secondary measurements were also taken, including skin symptom improvement (relevant to participants who also had psoriasis), changes in overall disease activity scores, physical functioning, and quality of life. The reported data shows that, for the primary measure (ACR20 joint improvement), around 50.5% of participants in the 75 mg group and 50.0% in the 150 mg group met that threshold, compared with 17.3% in the placebo group. For participants who had significant skin involvement from psoriasis, the reported data shows that 64.8% (75 mg group) and 61.1% (150 mg group) achieved a 75% reduction in their skin score (PASI75), compared with 8.3% in the placebo group; and 49.1% and 45.4% respectively achieved an even larger 90% skin score reduction (PASI90), compared with 3.7% in the placebo group. For the secondary measures, the reported data shows changes in overall disease activity scores, physical functioning scores, and daily activity scores were all numerically larger in both secukinumab groups than in the placebo group, though the scale and meaning of each of those measures differ. 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 Psoriatic Arthritis Trial, Completed

NCT01392326
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 Psoriatic Arthritis (PsA) using a specific set of medical criteria called CASPAR, your symptoms have been present for at least 6 months, and your condition is moderate to severe — with at least 3 tender joints and at least 3 swollen joints at the start of the trial
  • You have tested negative for two specific markers (Rheumatoid factor and anti-CCP antibodies) that are checked in a blood test
  • You have active plaque psoriasis, shown by at least one skin patch larger than 2cm, nail changes related to psoriasis, or a documented history of plaque psoriasis

Who may not be able to join:

  • You have a chest X-ray showing signs of an active infection or cancer in the chest
  • You have previously been treated with more than 3 different medications belonging to a group called TNFα inhibitors
  • You are currently taking strong opioid painkiller medications
  • You have ever received certain types of biologic (immune-system targeting) medications, except for those that target TNFα
  • There may be additional criteria not listed here (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.

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, Maroochydore, Queensland
Novartis Investigative Site, Malvern, Victoria

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

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 September 2011
Est. completion
1 October 2014

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇵🇭 Philippines 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇬 Singapore 🇸🇰 Slovakia 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo

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