122 results
The purpose of this study is to investigate how quickly and to what extent rogaratinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Rogaratinib will be labelled with 14 Carbon (…
Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…
The purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…
Primary Efficacy Objective: To define the minimum effective dose (MED) of the oral dose of E4 by evaluating changes in frequency and in severity of moderate to severe vasomotor symptoms (VMS) within each treatment arm at week 4 and 12. Secondary…
The primary objective of this study is to demonstrate efficacy of BIIB059compared with placebo in participants with active systemic lupuserythematosus (SLE), who are receiving background lupus standard ofcare (SOC) therapy in reducing disease…
Primary:To evaluate the effect of GLPG3970 on the pharmacokinetics (PK) of methotrexate (MTX) and its active metabolite 7-hydroxymethotrexate (7-OH MTX) in healthy subjectsTo evaluate the effect of GLPG3970 on the PK of sulfasalazine and its active…
Part 1:The purpose of this study is to determine whether LMTM inhibits monoamine oxidase (MAO). MAO is an enzyme (protein involved in reactions in the body) which breaks down tyramine. By giving participants tyramine which raises the blood pressure…
To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival (OS)
Primary:- To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.Secondary:- To evaluate the safety of a single IV dose of suvratoxumab.- To evaluate the effect of suvratoxumab on reducing the incidence of…
Primair1. Assessment of the pharmacological activity of BAY·1834845 and BAY 1830839 on IMQ induced skin inflammation compared to placebo (prednisolone serves as active control), as quantified by laser speckle contrast imaging (LSCI, perfusion/basal…
Primary objectives• To evaluate complement activation after topical imiquimod challenge• To evaluate complement activation after local UV-B challenge
In this study we will investigate how safe the new compound nipocalimab is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent nipocalimab is absorbed, transported, and eliminated…
Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…
PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…
To evaluate the efficacy of crovalimab compared to eculizumab
Main objective: To assess the efficacy of NBI-921352 as adjunctive therapy on the frequency of countable motor seizuresSecondary Objectives • To evaluate the efficacy of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change…
Objective 1: To compare MK-7684A to pembrolizumab alone with respect to ORR in participants with cervical cancer whose tumors express PD-L1 (CPS >=1)Objective 2: To compare MK-7684A to pembrolizumab alone with respect to PFS in participants…
In this study, we will investigate what the effect of the new compound emvododstat is on how quickly and to what extent 2 approved medications (dextromethorphan in Part 1 and rosuvastatin in Part 2) are absorbed, transported, and eliminated from the…
The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: - safety (to identify, assess, minimize, and appropriately manage the risks associated to…