Exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; active chronic plaque-type psoriasis

• Registration Number: EUCTR2013-002266-40-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-15
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion 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.
2.Men or women at least 18 years of age at time of screening.
3.Chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a PASI score = 10 at randomization.
4.Inadequate response, intolerance or contraindication to first-line conventional systemic psoriasis treatments as documented in the patient’s medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient’s lifestyle with the treatment are accepted.
5.At least one of the following to exclude chest infection and malignancy before initiation of a biologic immunomodulating therapy in accordance with current clinical guidelines:
oImaging of the chest (X-ray, computerized tomography (CT), or MRI) obtained within 12 weeks prior to screening, and evaluated by a qualified physician.
oMRI of the chest obtained at screening and evaluated by a qualified physician.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Patients incapable of giving full informed consent.
2.Forms of psoriasis other than chronic plaque-type at screening or randomization.
3.Drug-induced psoriasis at randomization.
4.Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
5.Use of other investigational drugs at the time of enrollment, or within 30 days or 10 half-lives of enrollment, whichever is longer.
6.Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or the IL-17A receptor.
7.Women
a.who are pregnant or breast feeding
b.who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women is required with sufficient lead time before inclusion.
8.Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Patients with psoriatic arthritis are not excluded.
9.Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
10.Known severe cardiovascular disease including but not limited to
a.congestive heart failure with ejection fraction <50% and NYHA class II-IV.
b.grade II or higher valvular disease.
c.coronary artery disease requiring reperfusion during the study period.
d.uncontrolled hypertension (repeated values of systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite maximally tolerated therapy). Patients who are at the time of screeningnot treated with maximal tolerated therapy may be rescreened after therapy has been successfully adjusted and well tolerated for at least 4 weeks.
e.documented coronary heart disease in the medical history.
f. symptoms or findings compatible with the presence of coronary artery disesase.
11.Inability to suspend therapy with angiotensin-converting-enzyme inhibitors, nitrates, calcium channel inhibitors, and angiotensin-receptor blockers for at least 12 hours before visits.
12.Subjects with a serum creatinine level exceeding 2.0 mg/dl at screening.
13.Screening total white blood cell count <2,500/µl, or platelets <100,000/µl or neutrophils <1,500/µl or hemoglobin <8.5 g/dl.
14.Chest X-ray, CT, or MRI with evidence of ongoing infectious or malignant process, obtained within 12 weeks prior to screening or after screening and prior to randomization, and evaluated by a qualified physician.
15.Active systemic infections during the last two weeks prior to randomization or any infection that reoccurs on a regular basis.
16.History of an ongoing, chronic or recurrent infectious disease including recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection.
17.Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to randomization.
18.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
19.History of hypersensitivity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified