Purpose of this Study
If you can join this study, you will be assigned to take one or more study medicines. These medicines are called SPY 001, SPY 002, and SPY 003, and some people will take combinations of these medicines. You will take the assigned medicine or medicines for up to 96 weeks.
During the study, which lasts about 33 months, you will have around 18 study visits or phone calls. At these visits, doctors will do tests such as blood draws, heart tests, and procedures like endoscopy to check your health and how the treatment is working.
Who Can Participate?
Eligibility
People can join this study if they are adults who were already in an earlier study called SPY123 201 and are able to join this follow up study. They cannot join if they have cancer or certain untreated cell changes in the body. They also cannot join if they are taking certain medicines that are not allowed in the study, such as strong immune system medicines or other experimental drugs.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to learn more about how certain study medicines work over a long period of time in people who have ulcerative colitis. These medicines are called SPY 001, SPY 002, and SPY 003. Researchers want to see how these medicines affect the body, how safe they are, and if they continue to help control the disease over time.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants with Inflammatory Bowel Disease (SPY123-202)
Principal Investigator
Nicole
Jawitz
Protocol Number
PRO00120433
NCT ID
NCT07652294
Phase
II
Enrollment Status
Pending Open to Enrollment