Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

Study Purpose

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

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:

Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization. 3. Moderate to severe psoriasis as defined at Randomization by:
  • - PASI score of 12 or greater, and - IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and - Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
4. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
  • - Topical treatment and/or - Phototherapy and/or - Previous systemic therapy

    Exclusion Criteria:

    1.
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization. 2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited. 3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor. 4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. 5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 7. History of hypersensitivity to any of study drug constituent

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.

NCT03589885
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 3
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 Canada, Germany, Iceland, Poland, Spain, United States
Conditions

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

Plaque Psoriasis
Additional Details

This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type 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, Portland, Oregon

Status

Recruiting

Address

Novartis Investigative Site

Portland, Oregon, 97210

Novartis Investigative Site, Miami, Florida

Status

Recruiting

Address

Novartis Investigative Site

Miami, Florida, 33155

Novartis Investigative Site, Marietta, Georgia

Status

Recruiting

Address

Novartis Investigative Site

Marietta, Georgia, 30060

Novartis Investigative Site, Saint Joseph, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Saint Joseph, Missouri, 64506

Novartis Investigative Site, Verona, New Jersey

Status

Recruiting

Address

Novartis Investigative Site

Verona, New Jersey, 07044

Novartis Investigative Site, Houston, Texas

Status

Recruiting

Address

Novartis Investigative Site

Houston, Texas, 77030

Novartis Investigative Site, San Antonio, Texas

Status

Recruiting

Address

Novartis Investigative Site

San Antonio, Texas, 78218

Novartis Investigative Site, Sugar Land, Texas

Status

Recruiting

Address

Novartis Investigative Site

Sugar Land, Texas, 77479

International Sites

Novartis Investigative Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Edmonton, Alberta, T5K 1X3

Novartis Investigative Site, Surrey, British Columbia, Canada

Status

Recruiting

Address

Novartis Investigative Site

Surrey, British Columbia, V3R 6A7

Novartis Investigative Site, Bielefeld, Germany

Status

Recruiting

Address

Novartis Investigative Site

Bielefeld, , 33647

Novartis Investigative Site, Essen, Germany

Status

Recruiting

Address

Novartis Investigative Site

Essen, , 45147

Novartis Investigative Site, Vechta, Germany

Status

Recruiting

Address

Novartis Investigative Site

Vechta, , 49377

Novartis Investigative Site, Witten, Germany

Status

Recruiting

Address

Novartis Investigative Site

Witten, , 58453

Novartis Investigative Site, Kopavogur, Iceland

Status

Recruiting

Address

Novartis Investigative Site

Kopavogur, , 201

Novartis Investigative Site, Warszawa, Mazowian, Poland

Status

Recruiting

Address

Novartis Investigative Site

Warszawa, Mazowian, 02 495

Novartis Investigative Site, Wroclaw, Poland

Status

Recruiting

Address

Novartis Investigative Site

Wroclaw, , 50-566

Novartis Investigative Site, Alicante, Comunidad Valenciana, Spain

Status

Recruiting

Address

Novartis Investigative Site

Alicante, Comunidad Valenciana, 03010

Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valencia, Comunidad Valenciana, 46014

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08003

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28031

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28041

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