active chronic plaque-type psoriasis
Conditions
Interventions
Product Name: Secukinumab, 150 mg
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: S
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Imaging of the chest (X-ray, computerized tomography (CT), or MRI) obtained within 12 weeks prior to screening, and evaluated by a qualified physician. o MRI 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate flow mediated dilation (FMD) by Doppler ultrasound at week 12 in subjects in treatment arm A (300 mg Secukinumab) compared to the pooled group of patients in treatment arms C and D (placebo up to week 12).;Secondary Objective: Cardiovascular Surrogate Markers: To evaluate flow mediated dilation by Doppler Ultrasound at weeks 4, 12, 24 and 52 To evaluate arterial stiffness by pulse wave analysis and pulse wave velocity at weeks 4, 12, 24 and 52 To evaluate soluble biomarkers from blood at weeks 4, 12, 24 and 52 ;Primary end point(s): Evaluation of flow mediated dilation by Doppler ultrasound in subjects in treatment arm A (300 mg Secukinumab) compared to the pooled group of patients in treatment arms C and D (placebo up to week 12).;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiovascular Surrogate Markers: To evaluate flow mediated dilation by Doppler Ultrasound To evaluate arterial stiffness by pulse wave analysis and pulse wave velocity To evaluate soluble biomarkers from blood To evaluate total plaque burden in the carotid artery and aorta as well as plaque composition in the carotid artery when measured in a complex plaque by 3.0 Tesla MRI in a sub-study (40 patients) ;Timepoint(s) of evaluation of this end point: Cardiovascular Surrogate Markers: Doppler Ultrasound at weeks 4, 12, 24 and 52 pulse wave analysis and pulse wave velocity at weeks 4, 12, 24 and 52 Evaluation of soluble biomarkers from blood at weeks 4, 12, 24 and 52 3.0 Tesla MRI at weeks 12 and 52 in a sub-study | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed