111 results
The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…
* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…
Primary ObjectiveThe primary objective of the study is to determine the recommended dose and regimen ofdurvalumab either as monotherapy or in combination with POM +/- dex in subjects with RRMM.Secondary ObjectivesThe secondary objectives are to:*…
To evaluate the plasma pharmacokinetic properties and safety of the research medication in healthy volunteers and in Patients with Systemic Mastocytosis and Allergic Asthma.
The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
Primary ObjectivesParts 1 (Subjects with F/MF genotypes) and 2 (Optional; Subjects with the F/F genotype)* To evaluate the safety and tolerability of VX 121 in TC with TEZ/VX 561 (deuterated IVA) * To evaluate the efficacy of VX 121 in TC with TEZ/…
To assess out to one-year the clinical status of patients who completed the double-blind part B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following:• Incidence of biopsy-proven allograft rejection or…
The primary objective of this study is:- To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA)The secondary objectives of this study are:-To compare the proportion of subjects with wAIHA…
Primary Objective & HypothesisIn subjects with first line (1L) stage IV MSI-H or dMMR CRC treated with first line (1L) pembrolizumab (MK-3475) versus SOC chemotherapies,Objective: To compare Progression Free Survival (PFS) per RECIST 1.1 by…
To evaluate the efficacy of AK002 in adult and adolescent subjects with active EoE when compared to placebo, efficacy endpoints will be co-primary:1) The proportion of subjects who achieve a peak esophageal intraepithelial count of <=6…
Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…
To determine which ovarian hyperstimulation regimen (FSH or CC) should be applied in IUI in couples with unexplained subfertility or mild male factor subfertility.
* To assess the safety and tolerability of inhaled PA101 delivered via eFlow in patients with IPF with refractory chronic cough.* To assess the efficacy potential of inhaled PA101 by measuring the changes in cough severity and the urge-to-cough as…
The primary objectives of this study are:• To evaluate the safety and tolerability of GS-9620 in subjects with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV)• To evaluate the efficacy of GS-9620 at Week 24…
The purpose of the study is to investigate to what extent CBD is safe and tolerated. It will also be investigated how quickly and to what extent CBD is absorbed and eliminated from the body (this is called pharmacokinetics). Furthermore the effect…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
assess the contraceptive efficacy and safety of the etonogestrel (ENG) 125 + 17*-estradiol (E2) 300 µg /day vaginal ring