Recruiting
Phase 2

BI 3032950

Sponsor:

Boehringer Ingelheim

Code:

NCT06636656

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BI 3032950 intravenous (Part A)

BI 3032950 subcutaneous (Part B)

Study Details

Brief summary:

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.

Conditions

Ulcerative Colitis

Study ID

NCT06636656

Start date

Dec 11, 2024

Status verified date

Aug, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All participants

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

Interventions

BI 3032950 intravenous (Part A)

BI 3032950 intravenous (Part A)

BI 3032950 subcutaneous (Part B)

BI 3032950 subcutaneous (Part B)

Primary outcome measure

  • Proportion of patients with clinical remission defined by the modified Mayo Score [mSC] with mSC of 0 to 2, including stool frequency subscore [SFS] of 0 or 1, rectal bleeding subscore [RBS] of 0, and centrally-read endoscopy subscore [ESS] of 0 or 1 [ Time Frame: Up to Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

Contacts

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Reliant Medical Research

Recruiting

Miami, Florida, United States, 33165-3639

Contacts

Illinois Gastroenterology Group - Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103-2937

Contacts

Atrium Health Gastroenterology and Hepatology

Recruiting

Charlotte, North Carolina, United States, 28204-2963

Contacts

Texas Digestive Disease Consultants

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Digestive Health Specialists

Recruiting

Tacoma, Washington, United States, 98405-2318

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-21.