BI 3032950 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

Disqualifiers: Crohn's disease, Colonic adenomas, Toxic megacolon, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis. This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years. Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial doctors to understand how your current treatments might interact with the study.

Research Team

Eligibility Criteria

Adults aged 18-80 with ulcerative colitis who haven't had success with or have stopped previous treatments can join this study. They must be able to use effective birth control methods and meet other criteria, including a confirmed diagnosis of UC for at least 3 months.

Inclusion Criteria

I am between 18 and 80 years old.

I was diagnosed with ulcerative colitis more than 3 months ago, confirmed by tests and biopsy.

I am using or willing to use effective birth control methods.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive BI 3032950 as an infusion into a vein every 4 weeks for 12 weeks

12 weeks

3 visits (in-person)

Treatment Part B

Participants receive BI 3032950 as an injection under the skin every 4 weeks for up to 2 years

Up to 2 years

Visits every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

BI 3032950 (Monoclonal Antibodies)

Trial OverviewThe trial is testing BI 3032950, given first as an intravenous infusion every four weeks (Part A), then as a subcutaneous injection every four weeks (Part B) if there's improvement after the initial phase. The study aims to see if it helps manage ulcerative colitis symptoms.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment2 Interventions

All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B.