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NCT01365455 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 738
- Enrollment target
NCT01365455: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01365455 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 738 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01365455, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 738 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of secukinumab compared to placebo 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. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-1
Interventions
- DRUG secukinumab 150 mg
- DRUG placebo to secukinumab 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01365455 record still lists
NCT01365455 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which secukinumab 150 mg is the first listed.
NCT01365455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01365455 about?
NCT01365455 is a clinical study titled "Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year". This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.
What is the current status of trial NCT01365455?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 738 participants. The study started on 2011-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01365455?
The interventions under investigation include: secukinumab 150 mg (DRUG), placebo to secukinumab 150 mg (DRUG).
Who is sponsoring clinical trial NCT01365455?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01365455's enrollment target sits among peer trials
738 479th of 2000 higher than 1,522 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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