Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

Study Purpose

This study will provide a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Written informed consent must be obtained before any assessment is performed - Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization - Moderate to severe plaque psoriasis as defined at baseline by: - ≥10% Body Surface Area (BSA) involvement and - PASI total score of ≥12 and - IGA mod 2011 score of ≥3 (based on a scale of 0-4)

Exclusion Criteria:

- Forms of diagnosed psoriasis other than chronic plaque psoriasis - Medication-induced or medication exacerbated psoriasis - Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors - Ongoing use of prohibited treatments - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03055494
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Hot Springs, Arkansas

Status

Completed

Address

Novartis Investigative Site

Hot Springs, Arkansas, 71913

Novartis Investigative Site, Los Angeles, California

Status

Recruiting

Address

Novartis Investigative Site

Los Angeles, California, 90033

Novartis Investigative Site, Santa Ana, California

Status

Recruiting

Address

Novartis Investigative Site

Santa Ana, California, 92701

Novartis Investigative Site, Atlanta, Georgia

Status

Recruiting

Address

Novartis Investigative Site

Atlanta, Georgia, 30342

Novartis Investigative Site, Indianapolis, Indiana

Status

Recruiting

Address

Novartis Investigative Site

Indianapolis, Indiana, 46256

Novartis Investigative Site, East Windsor, New Jersey

Status

Recruiting

Address

Novartis Investigative Site

East Windsor, New Jersey, 08520

Novartis Investigative Site, West Orange, New Jersey

Status

Recruiting

Address

Novartis Investigative Site

West Orange, New Jersey, 07052

Novartis Investigative Site, Buffalo, New York

Status

Recruiting

Address

Novartis Investigative Site

Buffalo, New York, 14203

Novartis Investigative Site, New York, New York

Status

Active, not recruiting

Address

Novartis Investigative Site

New York, New York, 10025 1737

Novartis Investigative Site, New York, New York

Status

Recruiting

Address

Novartis Investigative Site

New York, New York, 10065

Novartis Investigative Site, Portland, Oregon

Status

Completed

Address

Novartis Investigative Site

Portland, Oregon, 97223

Novartis Investigative Site, Pittsburgh, Pennsylvania

Status

Completed

Address

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213-3403

Novartis Investigative Site, Webster, Texas

Status

Recruiting

Address

Novartis Investigative Site

Webster, Texas, 77004

Novartis Investigative Site, Murray, Utah

Status

Recruiting

Address

Novartis Investigative Site

Murray, Utah, 84107

Novartis Investigative Site, Norfolk, Virginia

Status

Recruiting

Address

Novartis Investigative Site

Norfolk, Virginia, 23507

Novartis Investigative Site, Milwaukee, Wisconsin

Status

Completed

Address

Novartis Investigative Site

Milwaukee, Wisconsin, 53226

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