110 results
The primary objective of this study is:-To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression tocirrhosis and associated complications in subjects with NASH and bridging (F3)…
Main objective:Determine the recommended dose of durvalumab in combination withLEN +/- dex in subjects with NDMM.Secondary objectives:- Evaluate the safety and preliminary efficacy of durvalumab incombination with LEN +/- dex in subjects with NDMM-…
The primary efficacy objectives for this study are as follows:* To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the MCS at W14* To evaluate the efficacy of…
The primary objective of the study is to assess the safety of CORT125134 in patients with endogenousCushing*s syndrome. The secondary objective of the study is to assess the evidence of reduction incortisol activity following treatment with…
Primary:To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF…
Phase Ia: (dose escalation):- To determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) for M3814 (also referred to as MSC2490484A) in combination with fractionated palliative radiotherapy (RT) for tumors or metastases…
Primary Objective* To demonstrate that avelumab given alone or in combination with Pegylatedliposomal doxorubicin (PLD) is superior to PLD alone in prolonging Overall Survival(OS) in patients with platinum -resistant/platinum-refractory ovarian…
Primary ObjectivesThe primary objectives for this study are as follows:* To evaluate the safety and tolerability of atezolizumab and ipilimumab when administered in combination in patients with advanced or metastatic non-small cell lung cancer (…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
The primary objective of the study is to evaluate the long-term safety and tolerability of baricitinib in patients who have completed a previous baricitinib RA study. Safety and tolerability assessments will include:* Treatment-emergent adverse…
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
* To evaluate the effects of topically applied erythromycin and clindamycin in patients with facial AV* To explore skin and faecal microbiota in patients with AV;* To evaluate the effects of topically applied erythromycin and clindamycin on skin and…
PRIMARY OBJECTIVESParts 1 & 2* To assess safety and tolerability of the combination of GLPG2451 and GLPG2222, with and without GLPG2737 in adult subjects with CF* To characterize the PK of GLPG2451 and GLPG2222, with and without GLPG2737 (…
To assess the efficacy of Durvalumab monotherapy compared to SoC in terms of OS in patients with PD-L1 high expression (*25%) advanced NSCLC with wild type EGFR and ALK
Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…
To evaluate the safety and efficacy of PRX-102 in patients with Fabry disease currently treated with agalsidase alfa
Primary:* To characterize the safety and tolerability of long-term administration of bempedoic acid (ETC-1002) 180 mgSecondary:* To characterize the efficacy of long-term administration of bempedoic acid 180 mg/day as assessed by changes in low-…
Primary Objective: Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone (LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.Secondary Objectives:- Analyze the population…
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/…
The primary objectives of this study are:* To establish the preliminary safety and tolerability profile of RO6958688 in combination with atezolizumab* To determine the maximum-tolerated dose (MTD) in cycle 1 and in later cycles, if achieved, of…