136 results
1.1 Primary study objectives To investigate the safety, tolerability and biochemical effects of 225Ac-PSMA injected in patients with metastatic prostate cancer. Primary objective:- To assess the safety and tolerability of 225Ac-PSMA administered…
* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…
1. The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to ASA 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).2.…
EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…
EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…
The aim of this study is to assess differences in tumour microenvironment between HPV+ and HPV- oropharyngeal HNSCC using [68Ga]Ga-RGD2 PET/CT and perfusion CT.
The primary objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-use (>1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC…
Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…
Primary: To assess best overall response rate (ORR) up to 8 cycles. Secondary: ORR, complete response (CR), very good partial response (VGPR), progression free survival (PFS), overall survival (OS), safety, PK, exposure-response (efficacy and safety…
to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin (Rifaximin-EIR) for the prevention of recurrence of diverticulitis and diverticular complications in patients with a recent episode of…
Primary Trial ObjectivesBase Study1) Primary Efficacy Objective: To assess the efficacy of SCH 900222/MK-3222, hereafter referred to as MK-3222, compared to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the…
All primary and secondary objectives will compare zanubrutinib (also known as BGB-3111) plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation only.Primary:• To compare efficacy, as measured by…
In this study researchers want to learn about the safety of drug Osocimab at low and high doses in adult participants with kidney disease undergoing regular dialysis. Patients with kidney disease undergoing regular dialysis are at high risk for…
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to CIAP. The second objective is to determine the predictive value of a DOBRET to identify sustained responders.
Primary: To characterize safety and tolerability of TNO155 and identify a recommended dose and regimen for future studies in adult patients with advanced solid tumors. And a recommended dose of TNO155 in combination with nazartinib in patients with…
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
EFFICACY OBJECTIVESThe primary efficacy objective for this study is to evaluate the efficacy of lebrikizumabused as adjunctive therapy with TCS compared with TCS in patients with persistentmoderate to severe AD, as measured by Eczema Area and…
Primary Objective:To evaluate the efficacy of ASP8232 in reducing Urinary Albumin Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.Secundary Objectives:1. To…
PRIMARY OBJECTIVES * To evaluate the efficacy of lebrikizumab compared with placebo as measured by theability of patients to achieve lower daily doses of OCS while maintaining control oftheir asthma* To evaluate periostin as a predictive biomarker…