Psoriasis Clinical Trial
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.
This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).
During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.
K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).
Written informed consent must be obtained before any assessment is performed
Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
Moderate to severe plaque psoriasis as defined at baseline by:
≥10% Body Surface Area (BSA) involvement and
PASI total score of ≥12 and
IGA mod 2011 score of ≥3 (based on a scale of 0-4)
Forms of diagnosed psoriasis other than chronic plaque psoriasis
Medication-induced or medication exacerbated psoriasis
Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
Ongoing use of prohibited treatments
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
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There are 15 Locations for this study
Hot Springs Arkansas, 71913, United States
Los Angeles California, 90033, United States
Santa Ana California, 92701, United States
Atlanta Georgia, 30342, United States
Indianapolis Indiana, 46256, United States
East Windsor New Jersey, 08520, United States
West Orange New Jersey, 07052, United States
Buffalo New York, 14203, United States
New York New York, 10025, United States
New York New York, 10065, United States
Portland Oregon, 97223, United States
Pittsburgh Pennsylvania, 15213, United States
Webster Texas, 77004, United States
Murray Utah, 84107, United States
Norfolk Virginia, 23507, United States
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