A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the effect of secukinumab on aortic vascular inflammation and cardiometabolic biomarkers after 12 weeks of treatment, compared to placebo, and up to 52 weeks of treatment with secukinumab in adult subjects with moderate to severe chronic plaque-type psoriasis

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Updated on 23 November 2020
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Summary

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the effect of secukinumab on aortic vascular inflammation and cardiometabolic biomarkers after 12 weeks of treatment, compared to placebo, and up to 52 weeks of treatment with secukinumab in adult subjects with moderate to severe chronic plaque-type psoriasis

Description

We are studying an injectable medication, secukinumab, in the treatment of moderate to severe plaque psoriasis. Patients will undergo 3 FDG-PET/CT scans during the study to assess inflammation of the large vessels in the body and the effects of secukinumab on this inflammation. The trial lasts for 52 weeks. Initially patients will be expected to attend weekly appointments. After the first month, the appointments will occur every one to two months. Patients must be able to inject the medications themselves or have a family member or friend inject the medication for them.

Qualified participants will receive related medical examinations, study medication, and imaging studies at no cost, and may be eligible for compensation for their time and travel. Please call us for more information.

Details
Condition Psoriasis and Psoriatic Disorders
Clinical Study IdentifierTX144740
Last Modified on23 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy male or female age >18 years
Have a diagnosis of moderate to severe plaque psoriasis (10% Body Surface Area involved)
Have had a diagnosis of chronic plaque psoriasis for at least 6 months
Have failed other forms of therapy for psoriasis, including topical steroids, phototherapy, or prior systemic therapy are a candidate for biologic therapy and have never been given an IL-17 inhibitor in the past
Are able to attend appointments for 52 weeks
Are willing to not use any other psoriasis treatment during the study

Exclusion Criteria

Forms of psoriasis other than chronic plaque psoriasis
Previous exposure to secukinumab or other injectable medications directly targeting IL-17A or IL-17RA receptors
Diagnosis of active skin infections (bacterial, fungal, viral) or other active ongoing skin diseases
Subjects using cholesterol-lowering medication (e.g., statins) and not on a stable dose for at least 90 days prior to randomization and unable to remain on a stable dose for the duration of the study
Women who are pregnant, planning to become pregnant, or of child-bearing potential and not willing to use effective contraception
Current severe progressive or uncontrolled disease including uncontrolled diabetes (hemoglobin Alc >7%), myocardial infarction within 6 months prior to screening, unstable heart disease, stroke, kidney disease, uncontrolled high blood pressure (systolic >180 mmHg, diastolic >95 mmHg), cancer within the past 5 years, active tuberculosis, certain significant abnormalities in blood work, and other major medical conditions
History of HlV, Hepatitis C, or Hepatitis B
History or evidence of ongoing substance abuse within 12 months prior to screening, or not willing to limit alcohol use to ≤14 drinks per week within 4 weeks prior to Baseline and throughout the duration of the study
Allergy to rubber or latex
Other inclusion and exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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