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NCT01537432 · ClinicalTrials.gov registry record · Phase 2
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
A Phase 2 study of Psoriasis, Plaque-type Psoriasis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 12
- Study locations
NCT01537432: Completed Phase 2 study of Psoriasis, Plaque-type Psoriasis, sponsored by Novartis Pharmaceuticals.
NCT01537432 is a Phase 2 study of Psoriasis, Plaque-type Psoriasis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537432, a Phase 2 study of Psoriasis, Plaque-type Psoriasis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.
Primary Outcome
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Conditions Studied
Interventions
- DRUG placebo
- DRUG secukinumab
Study Locations (12)
New Jersey
- Novartis Investigative Site - East Windsor
- Novartis Investigative Site - Verona
New York
- Novartis Investigative Site - New York
- Novartis Investigative Site - Rochester
Texas
- Novartis Investigative Site - Dallas
- Novartis Investigative Site - Houston
Alabama
- Novartis Investigative Site - Birmingham
California
- Novartis Investigative Site - Pasadena
Indiana
- Novartis Investigative Site - Indianapolis
Missouri
- Novartis Investigative Site - St Louis
North Carolina
- Novartis Investigative Site - High Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01537432 record still lists
NCT01537432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Psoriasis, Plaque-type Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01537432 lists 12 locations in 9 states (New Jersey, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT01537432 about?
NCT01537432 is a clinical study titled "Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients". This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab u...
What is the current status of trial NCT01537432?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-01. Estimated completion is 2014-12.
What conditions does trial NCT01537432 study?
This clinical trial studies the following conditions: Psoriasis, Plaque-type Psoriasis.
What interventions are being tested in trial NCT01537432?
The interventions under investigation include: placebo (DRUG), secukinumab (DRUG).
Who is sponsoring clinical trial NCT01537432?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01537432 being conducted?
This trial has 12 study locations across Alabama, California, Indiana, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537432's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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