BI 3032950 for Ulcerative Colitis

Not currently recruiting at 65 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BI 3032950 to determine its effectiveness for ulcerative colitis, a condition causing inflammation and sores in the colon. Participants will receive the treatment first intravenously and then subcutaneously. The goal is to assess whether this treatment can improve symptoms such as abdominal pain and diarrhea. It may suit individuals who have had ulcerative colitis for over three months and have not found success with other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that BI 3032950 is likely to be safe for humans?

Research has shown that BI 3032950 has already undergone testing in humans, indicating it has passed at least one earlier trial focused on safety. This suggests the treatment is generally considered safe enough for further study. In those earlier trials, researchers tested the drug in healthy individuals to identify any side effects. Although specific results are not provided here, the fact that BI 3032950 is now being tested in people with ulcerative colitis suggests the initial safety results were acceptable. In the current study, doctors closely monitor participants for any unwanted effects to ensure ongoing safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike standard treatments for ulcerative colitis, which typically include anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, BI 3032950 offers a unique approach. Researchers are excited about BI 3032950 because it combines intravenous and subcutaneous administration, potentially improving patient convenience and compliance. Additionally, the specific mechanism of action for BI 3032950 is a novel aspect, promising to target pathways not addressed by current therapies, which could lead to better outcomes for patients who don't respond well to existing treatments.

What evidence suggests that BI 3032950 might be an effective treatment for ulcerative colitis?

Research has shown that BI 3032950 is being tested for its potential to help people with ulcerative colitis, a long-term condition causing inflammation in the colon. Early results suggest this treatment might reduce inflammation and improve symptoms. For those whose previous treatments failed, BI 3032950 could offer a new option. While more information is needed, initial studies indicate it might be promising. Participants in this trial will receive BI 3032950 either through an infusion in Part A or an injection in Part B, with doctors closely monitoring its effects. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Have you Ulcerative Colitis medications stopped working for you or caused side-effects that made you stop?

In the past two weeks, have you had loose or bloody stools most days?

Have you had ulcerative colitis for at least the past three months?

Exclusion Criteria

Have you had your colon removed or do you live with a permanent ileostomy/colostomy?

Are you taking high-dose steroids (>20 mg prednisone daily)?

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BI 3032950

Trial Overview The 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.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06636656

NCT06636656 | A Study to Test Whether BI 3032950 Helps ... 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 ...

2. crohnscolitisfoundation.org crohnscolitisfoundation.org/study-to-test-whether-bi-3032950-helps-people-with-ulcerative-colitis

Study to Test Whether BI 3032950 Helps People With ... 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 ...

3. clinicaltrials.eu clinicaltrials.eu/inn/bi-3032950/

BI 3032950: A Promising New Drug for Ulcerative Colitis ... BI 3032950 is a new drug currently being studied for its potential in treating ulcerative colitis, a chronic inflammatory bowel disease.

4. withpower.com withpower.com/trial/bi-3032950-for-ulcerative-colitis-6eb43

BI 3032950 for Ulcerative Colitis · Info for Participants 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 ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-bi-3032950-for-patients-with-moderate-to-severe-ulcerative-colitis/

Study on BI 3032950 for Patients with Moderate to Severe ... This study investigates the safety and efficacy of BI 3032950 as a treatment for patients with moderate to severe ulcerative colitis, a chronic inflammatory ...

6. synapse.patsnap.com synapse.patsnap.com/drug/8428a3205b5a494fa822a3f31ee53c21

BI-3032950 - Drug Targets, Indications, Patents A Phase I Single-blind, Randomised, Placebo-controlled, Parallelgroup Design Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Harmacodynamics