45 results
Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…
The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
The primary objective of this study is to evaluate the inhibition of PACAP-38 induced migraine-like attacks by AMG 334Secondary objectives:* To evaluate the inhibition of PACAP-38 induced headaches by AMG 334* To evaluate the safety, tolerability,…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with unresectable or…
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…
Primary objective:- To determine the effect of LIK066 on Liver Function test after 12 weeks of treatmentSecondary objectives: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment- To determine the effect of LIK066 on…
Part 1:Primary Objective- To assess the safety and tolerability of SBT-020 in early stage HD patients. Secondary Objective- To investigate the effect of SBT-020 on mitochondrial function, measured by dynamic 31P-MRS in calf muscles of early stage HD…
Primary Objective1. To evaluate the antitumor activity of pembrolizumab in combination with chemotherapy compared with saline placebo in combination with chemotherapy using PFS per RECIST 1.1 as assessed by BICR of imaging.2. To evaluate the…
The objective of this study is to investigate the mechanism(s) of action of tirzepatide in the kidney, in participants who are overweight or living with obesity and coexisting CKD, with and without T2D, to inform potential future kidney outcomes…
To compare disease free and overall survival of RCC patients, after adjuvant treatment with pembrolizumab after surgical renal resection. The objective of the study is to demonstrate that treatment with pembrolizumab, in comparison to placebo, will…
Primary Objectives:To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression free survival (PFS) (response evaluation by blinded independent central review using modified…
Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, withrespect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator.
1) Objective: To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with respect to PFS
The objective of the study is to compare event free surivial (EFS) and overall survival (OS) when administering pembrolizumab + SBRT vs placebo +SBRT.
The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…
Primary: To compare Event-free survival (EFS) per RECIST in subjects treated with pembrolizumab in combination with CRT and subjects treated with placebo in combination with CRT.Secondary:(1) To compare Overall Survival (OS) in subjects treated with…