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SUNSCAPE-2 UC EFC18359 - Clinical Trial

¿Cuál es el Propósito de este estudio?

Este estudio consta de dos partes. In the first part, people will be placed into one of three groups by chance. They may receive two doses of a study medicine called SAR447189, one dose of the study medicine and one dose of a placebo, or two doses of a placebo over about forty weeks. After this part, some people may be able to continue into the second part of the study, where everyone will receive the study medicine for a longer time.

The full study can last several years. During this time, participants will have many clinic visits. At these visits, doctors will do tests such as heart checks, blood tests, procedures to look inside the body, and ask questions about health and how the person feels.

¿Cuál es la Condición que se está estudiando?

Moderately to Severely Active Ulcerative Colitis (UC)

¿Quién puede participar en el Estudio?

People can join this study if they are adults between 18 and 80 years old and have moderate to severe ulcerative colitis. They must have already taken part in an earlier study called SUNSCAPE 1.

Grupo etario
Adultos

¿Qué Implica?

This study is testing a medicine called duvakitug for people who have moderate to severe ulcerative colitis, which is a disease that causes swelling and sores in the intestines. Researchers want to learn how safe this medicine is and if it helps reduce symptoms of the disease. The goal is to see if duvakitug can be a helpful treatment option for people with this condition.

Detalles del Estudio

Título Completo
A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-2)
Investigador Principal
Número de Protocolo
IRB: PRO00120447
NCT: NCT07185009
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health