Ulcerative Colitis study: BI
Official title A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
ClinicalTrials.gov ID: NCT06636656
What this study is testing
What is BI 3032950?
This is an investigational medicine being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether BI 3032950 helps people with ulcerative colitis. It looks at how well the drug works after previous treatments failed.
- Who it's for
- You may be able to join if you are an adult with ulcerative colitis. Your previous treatments must have stopped working or you stopped them.
- What's involved
- You would get the drug as a vein infusion every 4 weeks at first. Later, you would switch to shots under the skin every 4 weeks.
- Time commitment
- The study lasts up to 2 years with visits every 4 weeks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
- Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
- Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted...
- Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are...
- Further apply.
You likely can't join if
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or...
- Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
- Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
- Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
- Evidence of fulminant colitis or toxic megacolon at screening,
- Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
See the full eligibility criteria
- Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
- Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
- Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
- Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
- Further apply.
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
- Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
- Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
- Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
- Evidence of fulminant colitis or toxic megacolon at screening,
- Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
- Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
- Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Colorado Springs, Colorado, United States
- Kissimmee, Florida, United States
- Lakewood Rch, Florida, United States
- Miami, Florida, United States
- Gurnee, Illinois, United States
- Kansas City, Kansas, United States
- Charlotte, North Carolina, United States
- Cedar Park, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
- Leuven, Belgium
- Liège, Belgium
- Prague, Czechia
- Krakow, Poland
- Lublin, Poland
- Pabianice, Poland
- Poznan, Poland
- Rzeszów, Poland
- Sopot, Poland
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Colorado Springs, Colorado, United States; Kissimmee, Florida, United States; Lakewood Rch, Florida, United States; Miami, Florida, United States; Gurnee, Illinois, United States; Kansas City, Kansas, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.