Publications by authors named "Julie Dietrich"
Article Synopsis
- Primary biliary cholangitis (PBC) is a chronic liver disease affecting bile ducts, and the effectiveness of elafibranor, a dual PPAR α and δ agonist, in treating PBC was investigated through a clinical trial.
- In a phase 3, double-blind trial with 161 participants, those treated with elafibranor showed a significant biochemical response (51%) compared to only 4% in the placebo group, indicating substantial improvement in liver function.
- While 15% of elafibranor-treated patients normalized their alkaline phosphatase levels, the results for reducing itching (pruritus) between the elafibranor and placebo groups were not statistically
The current document has been developed by the Liver Forum who mandated the NAFLD-Associated Comorbidities Working Group - a multistakeholder group comprised of experts from academic medicine, industry and patient associations - to identify aspects of diverse comorbidities frequently associated with non-alcoholic steatohepatitis (NASH) that can interfere with the conduct of therapeutic trials and, in particular, impact efficacy and safety results. The objective of this paper is to propose guidance for the management of relevant comorbidities in both candidates and actual participants in NASH therapeutic trials. We relied on specific guidelines from scientific societies, when available, but adapted them to the particulars of NASH trials with the aim of addressing multiple interacting requirements such as maintaining patient safety, reaching holistic therapeutic objectives, minimising confounding effects on efficacy and safety of investigational agents and allowing for trial completion.
View Article and Find Full Text PDFBackground: Researchers are increasingly motivated to move toward patient-centric drug development. TransCelerate has identified improved "information exchange" as an important component of creating a more satisfying clinical trial experience for patients and their health care professionals (HCPs).
Methods: Patients, sponsors, sites, and HCPs were engaged through surveys, interviews, and/or advisory boards to capture the current status of information exchange and identify possible future practices between the major stakeholders within the clinical research ecosystem.
Objective: To determine the safety and efficacy of AMG 747, an oral inhibitor of glycine transporter type-1 (GlyT1), as an add-on to antipsychotic therapy in clinically stable people with schizophrenia with enduring negative symptoms.
Method: Analysis of pooled data from two phase 2 studies. Adults diagnosed with schizophrenia stabilized on antipsychotic medication randomized (2:2:2:3) to orally receive daily AMG 747 (5mg, 15mg, or 40mg) or placebo.
Background: The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention.
Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, patients aged 18-60 years with 4 to 14 migraine days per month were enrolled at 59 headache and clinical research centres in North America and Europe, and randomly assigned in a 3:2:2:2 ratio to monthly subcutaneous placebo, AMG 334 7 mg, AMG 334 21 mg, or AMG 334 70 mg using a sponsor-generated randomisation sequence centrally executed by an interactive voice response or interactive web response system.