11 results
Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…
1. How functions the dopaminergic neurotransmission in adult patients with VCFS who are functioning on an intellectual level of moderate to severe impairment (IQ < 55) by a) a strong cognitive decline or b) a premorbid level of functioning.2…
Main goal is to gain more insight in the role of dopaminergic neurotransmission in rewards, motivation and the attribution of salience in the etiology of psychosis. Primary question is whether a change in blood oxygation level dependent (BOLD) fMRI…
The first objective is measuring striatal D2 receptor binding before and after dopamine depletion with AMPT in the UHR population compared to healthy controls, and investigate whether dopaminergic dysregulation is present prior to transition to…
With this study we want to identify the common aetiology and neurobiology of EFD, by employing pharmacological and genetic imaging in three neuropsychiatric disorders. We want to identify an underlying functional and structural model for EFD,…
Primary Objective:* To assess the effect of BGF MDI relative to GFF MDI and BFF MDI on the rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbationsSecondary Objectives:* To assess the effect of BGF MDI relative to GFF…
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.