A PHASE 2/3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORAL OZANIMOD (RPC1063) IN PEDIATRIC SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WITH AN INADEQUATE R…

Pediatrics Gastroenterology Digestive Disease Pediatric Subjects

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Teva TV48574-IMM-20036

Internal Medicine Gastroenterology Digestive Disease Adult Subjects

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: - To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures - To evaluate the safety and tolerability of the 2 different dose regimens - To evaluate the immunogenicity of the 2 different dose regimens The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

TAK-999-3001 AATD

Internal Medicine Gastroenterology Liver Disease Adult Subjects

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

AstraZeneca D5244C00001 Crossing EoE

Internal Medicine Immunology Gastroenterology Esophagitis Digestive Disease Adult Subjects

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

Pfizer C4151002 UC

Internal Medicine Gastroenterology Digestive Disease Adult Subjects

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

Takeda TAK-062-2001 Celiac

Internal Medicine Gastroenterology Digestive Disease Adult Subjects

The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

Escient EP-547-201 PBC or PSC

Internal Medicine Heart and Vascular Gastroenterology Electrophysiology Liver Disease Adult Subjects

This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)

Inventiva NATiV3 NASH

Internal Medicine Endocrinology Gastroenterology Diabetes Liver Disease Adult Subjects

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Mirum VLX-601 PBC

Internal Medicine Gastroenterology Liver Disease Adult Subjects

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Exact Sciences Altus HCC Test

Cancer Internal Medicine Gastroenterology Infectious Disease Liver Disease Liver Cancer Viral Infectious Diseases Infectious Disease Adult Subjects

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

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