125 results
To evaluate the efficacy of HDM-SPIRE in the reduction of symptoms and the use of allergy rescue medication associated with HDM allergy in subjects with clinically relevant symptoms.
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…
The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…
The primary objective for this study is as follows:* To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used incombination with bendamustine compared with bendamustine alone in patients with indolentNHL refractory to…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
Primary objectiveTo compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-…
The objectives of this clinical trial are as follows:1. To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare2. To assess the clinical activity of various doses of OLT1177 Capsule in…
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…
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 test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…
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 (…
Co Primary Objectives:1. To demonstrate that avelumab in combination with platinum based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum based chemotherapy alone followed by observation (Arm A) in prolonging progression…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) in combination with chemotherapy drugs of physician's choice (which includes Nab-paclitaxel, Paclitaxel or…
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…
- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.
Primary Objective:To evaluate the efficacy of ELX/TEZ/IVA in subjects 6 through 11 years of age with CF, heterozygous for F508del and a MF mutation (F/MF)Secondary Objectives:• To evaluate the PD of ELX/TEZ/IVA• To evaluate the safety of ELX/TEZ/IVA
The purpose of this study is to investigate the safety and tolerability of the new compound PB006 (natalizumab) when it is administered to healthy volunteers. PB006 has not been administered to humans before. It has been previously tested in the…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
Primary:To compare the efficacy of abrocitinib 200 mg once daily (QD) versus dupilumab (as per label guidelines) in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).Key SecondaryTo compare the efficacy…