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Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE) 1

SC secukinumab is also in phase III development for scalp psoriasis in the US and psoriasis in France. Approximately 30 subjects will be enrolled in the US. Novartis issued results of two phase IIIb studies of Cosentyx (secukinumab) for psoriasis of the palms, soles of feet and nails. GESTURE enrolled 205 subjects with moderate to severe nonpustular palmoplantar psoriasis randomized 1:1:1 to receive either Cosentyx 300mg, Cosentyx 150mg or placebo subcutaneously for 76 weeks. We evaluated the efficacy and safety of apremilast in palmoplantar psoriasis. Significantly more patients taking apremilast with moderate to severe palmoplantar psoriasis (baseline PPPGA score 3) achieved PPPGA score 0 (clear) or 1 (almost clear) compared with placebo at week 16 (48 vs 27; P.

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE) 2Secukinumab has been approved in Europe (EMA, 2015a) and in the USA (FDA, 2015) for the treatment of moderate to severe plaque psoriasis at a dose of 300 mg (once a week for 4 weeks, then once a month) based on the results of a series of pivotal Phase III studies. The 4D treatment was effective but not tolerable. OBJECTIVE: To evaluate the efficacy and safety of an anti- IL-17A monoclonal antibody, ixekizumab, for the treatment of psoriasis. RESULTS: Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of secukinumab in subjects with moderateto- severe palmoplantar psoriasis (palmoplantar Investigator’s Global Assessment (ppIGA) 3). Cosentyx (secukinumab) – Novartis Enrollment closed; Study of safety, tolerability, and efficacy of secukinumab in subjects with moderate to severe palmoplantar psoriasis (GESTURE) (clinicaltrials.

Secukinumab treatment maintains efficacy in moderate to severe plaque psoriasis through second year of treatment: A randomized extension of the ERASURE and FIXTURE studies. Secukinumab efficacy and safety in subjects with moderate to severe palmoplantar psoriasis in a Phase 3b study (GESTURE). Secukinumab safety and tolerability I n patients with active psoriatic arthtitis and psoriasis: Results from pooled safety analysis. 8 A multicentre, double-blind, open- label, four-year extension to the SCULPTURE and STATURE studies was carried out. During the core study, PASI75 responders at week 12 were randomised to double-blind maintenance treatment of subcutaneous secukinumab 300mg or 150mg, administered either at a four- week fixed-interval (FI) regimen (320 patients) or in a retreatment-as-needed (RAN) regimen (322 patients). 23.5; xerosis cutis, 10.6; palmoplantar pustulosis, 5.3; psoriasis, 3.8;

Secukinumab

Methods We employed the human skin xenograft transplantation model in which psoriatic plaques and nonlesional keratome skin biopsies obtained from donors with moderate to severe plaque psoriasis were transplanted on to immuno-deficient mice. The end point of the study was severe dry-eye syndrome sufficient to produce visual loss secondary to corneal opacification, ulceration, or vascularization. A symptomatic score of 0-6 was mild, 6.1-12 moderate and 12.1-18 severe dry eye. Establishing the tolerability and performance of tamarind seed polysaccharide (TSP in treating dry eye syndrome: results of a clinical study.

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