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NCT01358578 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,306
Enrollment target

NCT01358578: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT01358578 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,306 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01358578, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,306 participants
Enrollment target

Study Summary

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Primary Outcome

A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

Interventions

  • DRUG Placebo
  • DRUG etanercept
  • DRUG secukinumab (AIN457)

Trial Details

FieldValue
Enrollment Target 1,306 participants
Start Date 2011-06
Est. Completion 2013-07
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01358578 record still lists

NCT01358578 is an interventional study that assigns participants to a tested intervention. Its 1,306 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01358578 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01358578 about?

NCT01358578 is a clinical study titled "Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis". This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

What is the current status of trial NCT01358578?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,306 participants. The study started on 2011-06. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01358578?

The interventions under investigation include: Placebo (DRUG), etanercept (DRUG), secukinumab (AIN457) (DRUG).

Who is sponsoring clinical trial NCT01358578?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01358578's enrollment target sits among peer trials

1,306 188th of 2000 higher than 1,813 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01358578, the US trial registry maintained by the National Library of Medicine. NCT01358578 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.