Phase 3 Psoriasis Trial, Completed NCT01806597 Sponsor: Novartis Pharmaceuticals Condition: Psoriasis
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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 (NCT01806597) looked at a medicine called AIN457 (also known as secukinumab) in people with a skin condition affecting the palms of the hands and soles of the feet (palmoplantar psoriasis). The trial had two main treatment periods and a short follow-up phase. In the first period (up to 16 weeks), 68 people received AIN457 at a 150 mg dose, 69 received it at a 300 mg dose, and 68 received a placebo (a dummy treatment with no active ingredient). Participants were then followed for an extended period out to around 132 weeks, during which some people originally on placebo were switched to one of the AIN457 doses. The main thing the trial measured was how many participants achieved a score of "clear" or "almost clear" skin on a standardised rating scale (called the ppIGA) after 16 weeks, where they also had to have improved by at least 2 points from their starting score. The reported data shows that at 16 weeks, 22% of those on the 150 mg dose and 33.3% of those on the 300 mg dose met this measure, compared with 1.5% of those on placebo. The trial also tracked this same skin-score measure at various later time points, and reported a separate score (called ppPASI, a 0–72 scale where higher numbers mean more severe disease) to capture changes in the area and severity of skin affected. The reported data shows that by week 16, the average ppPASI score had dropped by about 9.7 points in the 150 mg group and about 11.3 points in the 300 mg group, compared with a drop of about 3.2 points in the placebo group. Later time-point data was also reported, but some measurements in the later periods were not fully reported for all sub-groups in the data provided. 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 Psoriasis Trial, Completed

NCT01806597
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 had moderate to severe plaque psoriasis for at least 6 months before joining the study, with significant affected areas on the palms of your hands and/or soles of your feet, plus at least one psoriasis plaque elsewhere on the body.
  • Your psoriasis has not been well controlled by creams or ointments (including strong steroid creams), light therapy, or previous systemic (whole-body) treatments, meaning stronger treatment options may be needed.

Who may not be able to join:

  • You have a type of psoriasis other than chronic plaque psoriasis, such as pustular psoriasis, erythrodermic psoriasis, or guttate psoriasis.
  • Your psoriasis was triggered or made worse by certain medications, such as beta-blockers, calcium channel blockers, or lithium.
  • You are currently using certain treatments not allowed in this trial, such as steroid creams, steroid tablets, or UV light therapy (note: there may be a waiting period after stopping these before you can join — confirm with trial site).
  • You have previously been treated with secukinumab (AIN457) or any other biological medicine that targets a protein called IL-17 or its receptor.
  • You have taken part in another clinical trial or used an experimental drug within the past 4 weeks (or longer, depending on the drug involved).
  • You have another active inflammatory condition besides psoriasis that could interfere with how the trial results are assessed.
  • You have a known allergy or sensitivity to any of the ingredients in the study treatment.

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 21 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, Sydney, New South Wales
Novartis Investigative Site, Woolloongabba, Queensland
Novartis Investigative Site, Carlton, Victoria
Novartis Investigative Site, East Melbourne, 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
19 June 2013
Est. completion
2 November 2016

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇮 Finland 🇭🇺 Hungary 🇮🇱 Israel 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇹 Portugal 🇷🇺 Russia 🇸🇰 Slovakia 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment

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: 21 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