Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01640951 · ClinicalTrials.gov registry record · Phase 3
4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
A Phase 3 study of Moderate to Severe Chronic Plaque-Type Psoriasis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT01640951: Completed Phase 3 study of Moderate to Severe Chronic Plaque-Type Psoriasis, sponsored by Novartis Pharmaceuticals.
NCT01640951 is a Phase 3 study of Moderate to Severe Chronic Plaque-Type Psoriasis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 675 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640951, a Phase 3 study of Moderate to Severe Chronic Plaque-Type Psoriasis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
Study Summary
CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.
Primary Outcome
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AIN457 150 mg
- DRUG AIN457 300 mg
Study Locations (20)
Florida
- Novartis Investigative Site - Jacksonville
- Novartis Investigative Site - Jacksonville
- Novartis Investigative Site - Miami
- Novartis Investigative Site - South Miami
- Novartis Investigative Site - West Palm Beach
California
- Novartis Investigative Site - Fresno
- Novartis Investigative Site - Pasadena
- Novartis Investigative Site - San Francisco
Illinois
- Novartis Investigative Site - Champaign
- Novartis Investigative Site - Skokie
Nevada
- Novartis Investigative Site - Henderson
- Novartis Investigative Site - Las Vegas
Georgia
- Novartis Investigative Site - Atlanta
Indiana
- Novartis Investigative Site - Indianapolis
Kansas
- Novartis Investigative Site - Overland Park
Massachusetts
- Novartis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2012-09-16 |
| Est. Completion | 2017-05-04 |
| Phase | Phase 3 |
What the finished NCT01640951 record still lists
NCT01640951 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Moderate to Severe Chronic Plaque-Type Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01640951 names 20 study sites across 12 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01640951 about?
NCT01640951 is a clinical study titled "4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis". CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of...
What is the current status of trial NCT01640951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2012-09-16. Estimated completion is 2017-05-04.
What conditions does trial NCT01640951 study?
This clinical trial studies the following conditions: Moderate to Severe Chronic Plaque-Type Psoriasis.
What interventions are being tested in trial NCT01640951?
The interventions under investigation include: Placebo (DRUG), AIN457 150 mg (DRUG), AIN457 300 mg (DRUG).
Who is sponsoring clinical trial NCT01640951?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01640951 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Moderate to Severe Chronic Plaque-Type Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01640951's enrollment target sits among peer trials
675 538th of 2000 higher than 1,458 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04788277 · 675 participants
Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)
- NCT05356234 · 675 participants · NA
Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.
- NCT06070870 · 675 participants · NA
Health Education Approach to Lung Screening
- NCT06357533 · 675 participants · Phase 3
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI