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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 is a Phase 2 study of Psoriasis, Plaque-type Psoriasis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 36 participants. The trial reports 12 study locations across 9 states.

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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.

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

FieldValue
Enrollment Target 36 participants
Start Date 2012-01
Est. Completion 2014-12
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01537432

The ClinicalTrials.gov registry entry for NCT01537432 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 9 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.