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RecruitingPhase 2

A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Infusions, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks."
  • "Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin."
  • "They get BI 3032950 injections under the skin every 4 weeks for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether BI 3032950 helps adults ages 18 to 80 with ulcerative colitis, a disease that causes swelling and sores in the large bowel. It is for people whose past treatment did not work well or was stopped. Participants get the study drug through a vein, then as shots under the skin.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 80 years old when you agree to join.
  • You were diagnosed with ulcerative colitis at least 3 months before screening. The diagnosis must be backed by symptoms, a camera exam of the bowel, and a tissue sample report.
  • A past biologic or targeted treatment did not work well, stopped working, caused side effects you could not handle, or was stopped for another reason.
  • Women who can become pregnant must use highly effective birth control. Men must use condoms.
  • Other rules for joining also apply.

Who can't join

  • You have Crohn’s disease, signs of Crohn’s disease, or another listed type of bowel inflammation instead of ulcerative colitis.
  • You have certain abnormal cells or growths in the large bowel, unless they were properly removed.
  • You have a tumor in the digestive tract, primary sclerosing cholangitis (a disease that scars bile ducts), or a known narrowing of the large bowel.
  • At screening, you have very severe bowel inflammation or toxic megacolon, a dangerous swelling of the large bowel.
  • You have a surgically made bowel pouch, an opening that lets stool leave through the belly, or a lasting narrowing of the bowel that causes symptoms.
  • You have had or expect to need surgery for ulcerative colitis. Some people with past large bowel surgery may be allowed to join.
  • You have or have had an abscess (a pocket of pus), unless it was drained and treated at least 6 weeks before the first study dose and is not expected to need surgery.
  • Other rules may also prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 inclusion criteria apply. Exclusion criteria * 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.

Study sites (14)

AZ

CO

FL

IL

KS

NC

NY

TX

WA