Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for … (NCT03440736) | Clinical Trial Compass
CompletedPhase 4
Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome
Germany781 participantsStarted 2018-02-28
Plain-language summary
This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could primarily improve skin symptoms and secondly cardiometabolic status more than Secukinumab alone in psoriasis patients with concomitant metabolic syndrome by targeting the shared pathophysiology behind both diseases, which is systemic inflammation.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Written informed consent must be obtained before any assessment is performed.
✓. Men or women of at least 18 years of age at the time of screening.
✓. Patients must be able to understand and communicate with the investigator and must be willing and able to comply with all study procedures.
✓. Patients with moderate to severe plaque-type psoriasis who are candidates for systemic therapy, diagnosed at least 6 month before randomization and baseline value of
✓. Fulfillment of Metabolic Syndrome definition (Alberti et al., 2009), which means fulfillment of ≥3 of the following criteria at screening visit:
✓. Willingness and motivation to actively participate in a lifestyle intervention, which means patients need to be willing to increase physical activity and to change dietary habits.
Exclusion criteria
✕. Forms of psoriasis other than chronic plaque-type (e.g. pustular, erythrodermic and guttate psoriasis) at screening.
✕. Previous exposure to Secukinumab or any other biologic drug directly targeting IL17A or the IL17A receptor (e.g. Brodalumab, Ixekizumab).
What they're measuring
1
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28
✕. Exposure to anti-TNF treatment during 1 year prior to baseline.
✕. Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at screening.
✕. History of hypersensitivity to Secukinumab, trehalose-dihydrate, L-histidine, L-histidinhydrochloride-monohydrate, L-methionine, polysorbate 80, water for injection, or to substances of similar chemical classes.
✕. History of latex hypersensitivity.
✕. Ongoing participation (including safety follow-up period) in other interventional or non-interventional studies in any dermatological indication
✕. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to (Table 5-1). Note: Administration of live vaccines 6 weeks prior to baseline (visit 2) or during the study period is also prohibited.