Mirikizumab for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+644 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people who've had ulcerative colitis (UC) for at least 3 months and haven't responded well to or can't tolerate standard UC treatments. Women must agree to use contraception. It's not open to those who've had a colectomy, have toxic megacolon, previous treatment with certain antibodies, or are diagnosed with Crohn's disease.

Inclusion Criteria

My UC treatments have not worked or caused side effects.

I have been diagnosed with ulcerative colitis for at least 3 months.

My ulcerative colitis is moderate to severe, confirmed by a specific score.

See 1 more

Exclusion Criteria

I have had surgery to remove part or all of my colon.

I have been treated with medications targeting IL12 or IL23.

I currently have toxic megacolon.

See 1 more

Treatment Details

Interventions

Mirikizumab (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests the safety and effectiveness of Mirikizumab in treating moderately to severely active UC compared to a placebo. Participants will be randomly assigned either the drug or placebo without knowing which one they receive.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 300 mg Mirikizumab IV Q4W ME2Experimental Treatment1 Intervention

300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Group II: 300 Milligram (mg) Mirikizumab IV Q4WExperimental Treatment1 Intervention

300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Group III: Placebo IV Q4W Maximum Extended Enrollment (ME2)Placebo Group1 Intervention

Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Group IV: Placebo Intravenous (IV) Every 4 Weeks (Q4W)Placebo Group1 Intervention

Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.