A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (TOPAZ-UC) Co-Administered with Mirikizumab in Adults with Moderate to Severe UC
Published: 10/15/2025
General Information:
The main purpose of the study is to evaluate the effectiveness and safety of the study drug LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
Eligibility:
You may be able to take part in this study if you:
Are between 18 and 80 years of age
Have been diagnosed with ulcerative colitis for at least 3 months
Are currently experiencing moderate to severe ulcerative colitis.
Have tried some of the other treatments for ulcerative colitis, but they have not worked for you.
Individuals will be excluded based on conditions that could interfere in study assessments or increase a participant’s risk of experiencing side effects during the study. Click the link to find out if you may be eligible.
Study Details:
Study description/explanation of participation:
Approximately 252 participants from across the world will join this study and be randomly assigned to get at least 1 investigational medicine during the first period of the study. Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Description of treatment or intervention (mechanism of action):
Researchers are looking for new ways to help treat and reduce symptoms of UC, like using 2 treatments together. This is the first study to evaluate the co-administration of LY4268989 and mirikizumab. The results of this study will be used to learn more about:
- The efficacy and safety of LY4268989 co-administered with mirikizumab
- How LY4268989 co-administered with mirikizumab effects in the body
Patient Participation Requirements:
During the study, participants will have visits with doctors and researchers in-person at a clinic. The visit frequency will be every 2, 4, 8, or 12 weeks, depending on the visit type and the study period. If you choose to take part, you will get at no cost to you:
- All study-related medicines
- All study-related care and check-ins, and
- Access to specialized doctors and researchers in ulcerative colitis
Possible risks and side effects:
Participant safety and wellbeing is the top priority. Doctors discuss potential benefits and risks during the Informed Consent Process to safeguard participants. Participants are closely monitored throughout the trial and their health is checked regularly.