STARSCAPE-1_Crohn's_EFC18326_Jawitz_PRO00119061 - Clinical Trial
What is the Purpose of this Study?
This study has three parts, called Sub-Studies. In Sub-Study 1, people receive a medicine called duvakitug. In Sub-Study 2, people are placed by chance into one of three groups and may get duvakitug, a placebo with no medicine, or both depending on the group. In Sub-Study 3, people are placed by chance into one of two groups to get different doses of duvakitug.
The whole study lasts about thirty-five weeks and includes fifteen clinic visits. During these visits, people will have tests such as heart checks, blood tests, endoscopy, biopsies, and questionnaires.
Depending on when a person joins, they will be placed in Sub-Study 1 or Sub-Study 2. In both of these, they will take the study drug every two weeks for twelve weeks. After finishing one of these parts, they may be asked to join Sub-Study 3 for another twelve weeks of treatment, or they may be asked to join a different study called STARSCAPE 2.
Moderate to severe Crohn's Disease
Who Can Participate in the Study?
People can join this study if they are between 18 and 80 years old and have Crohn's Disease that is moderate to severe. They must also have tried other treatments for Crohn's Disease that did not work well enough, stopped working, or caused side effects they could not handle.
What is Involved?
This study is trying to learn if a medicine called duvakitug can help people who have moderate to severe Crohn's Disease. Crohn's Disease is an illness that causes swelling and pain in the digestive system. The study also wants to find out how safe the medicine is for people who take it.
Study Details
