Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

Spyre_Skyline-UC_Jawitz - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Moderately to Severely Active Ulcerative Colitis

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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 G. Jawitz, MD
Gastroenterologist
Protocol Number
IRB: PRO00118888
NCT: NCT07012395
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
Support Duke Health research or honor a loved one with a tribute gift.
Giving to Duke Health