23 results
Primary: To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNFα inhibitor naïve.…
This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after…
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebobased on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- mTTS structural damage week 24-…
To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.
To assess the efect of IL-17 blockade on:- the global synovial histology and inflammatory infiltration- the number and type of IL-17 producing cells in SpA synovitis- the productuion of inflammatory mediators (including other IL-17 related cytokines…
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
This study will assess if a more prolonged dose interval (every 6 weeks compared to every 4 weeks) will allow psoriasis patients who achieveclear or almost clear skin after 24 weeks of secukinumab treatment - Psoriasis Area and Severity Index (PASI…
In this study the best treatment of DSPS will be investigated by comparison of existing treatments. We will investigate is patients with ADHD and DSPS have less favorable blood values for biomarkers of chronic diseases in comparison with norm values…
This study is designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response.Secondary (key only): ASAS responses in the…
The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Primary Objective- To demonstrate dose proportionality between 1 mg and 5 mg of PedPRM (Neurim Pharmaceuticals Ltd.) following a single oral dose in healthy male and female volunteers (treatment A and C), under fed conditions.Secondary Objectives-…
Primary: To evaluate the sustainability of subject benefits as quantified by the ASAS20 during long-term treatment.Secondary: ASAS40, safety and tolerability.
Primary: To demonstrate the superiority of secukinumab 150 mg and/or 300 mg to placebo in subjects with moderate to severe palmoplantar psoriasis as assessed by the palmoplantar Investigator*s Global Assessment (ppIGA) at Week 16.Secondary: Efficacy…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- PASI75 week 24- PASI90 week 24-…
To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14