18 results
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
Primary objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
Primary ObjectiveThe primary objective of this study is to evaluate the initial efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).Secondary ObjectivesThe secondary objectives…
Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To evaluate the safety of guselkumabSecondary Objectives:Phase 2:- To evaluate the dose-response of guselkumab to inform…
Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in jPsAEvaluate immunogenicity of ustekinumab and guselkumab in jPsA
Synopsis, page 4-5OBJECTIVES:The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84.The secondary objectives of this study include the following:• To evaluate the effect of obicetrapib on LDL-C levels…
The primary objective of this study is to evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.
Primary objective: To investigate changes in inflammatory pathways induced by IL-23p19 blockade with guselkumab, in HS lesional skin at week 16 compared to baseline (t=0).Secondary objectives:- To determine the efficacy of 4 doses of guselkumab of…
The primary objective of this study is to evaluate the pharmacodynamics (PD) (apolipoproteins/lipid particles and cholesterol efflux) of obicetrapib in cerebrospinal fluid (CSF) and plasma (apolipoproteins/lipid particles) in patients with early…
Primary objective:- To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…
The study is divided into two sections:Part A is a healthy volunteer controlled observational study to determine the course of the disease over time to:- Evaluate disease-related biomarkers in psoriasis when compared with healthy volunteers;-…
Primary objectiveTo compare the efficacy of brodalumab with guselkumab in adult subjects with moderate to severe plaque psoriasis and prior inadequate response to ustekinumab. Secondary objectives:To evaluate the efficacy of brodalumab compared with…
Primary ObjectivesThe primary objective of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged >=6 through <18 years with chronic plaque psoriasis.Secondary ObjectivesThe secondary objectives…
The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84. The secondary objectives of this study include the following: - To evaluate the effect of obicetrapib on fasting apolipoprotein B (ApoB), non-…
To explore the effect of treatment with guselkumab in subjects with Familial Adenomatous Polyposis (FAP) on rectal/pouch polyp burden (the sum of the polyp diameters)
Induction Study 1 (Phase 2b Induction Dose-ranging Study)ObjectivesPrimary ObjectivesThe primary objectives of this study are, in participants with moderately to severely active UC:* To evaluate the efficacy of guselkumab as induction therapy.* To…