Purpose of this Study
If you can join, you will be placed in Part A or Part B based on when you start. In Part A, you will get one of three study medicines: SPY001, SPY002, or SPY003. In Part B, you will get one of these medicines, a mix of two medicines, or a placebo, which does nothing. The study will last about 97 weeks, and you will have around 20 visits or phone calls. During these, doctors will do tests like blood draws, endoscopy with biopsy, heart checks, and x-rays.
Who Can Participate?
Eligibility
To join this study, you must be 18 years or older and have ulcerative colitis that is moderate to severe. If you take steroid pills, your dose must stay the same for at least 2 weeks before getting the study medicine. You can join if other treatments for ulcerative colitis did not work well for you, stopped working, or caused bad side effects.
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
This study wants to learn how three medicines, called SPY001, SPY002, and SPY003, affect people who have a sickness called ulcerative colitis. Ulcerative colitis is a disease that causes swelling and sores in the large intestine.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
Principal Investigator
Nicole
Jawitz
Protocol Number
PRO00118888
NCT ID
NCT07012395
Phase
II
Enrollment Status
Pending Open to Enrollment