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

Phase 2Active Not RecruitingNCT06636656

Boehringer Ingelheim45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (42)

One of a Kind Clinical Research Center

Scottsdale, Arizona, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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

The modified Mayo score (mMS) consists of 3 components 1. Stool frequency subscore (SFS) 2. Rectal bleeding subscore (RBS) 3. Endoscopy subscore (ESS) Each component is graded from 0 = none to 3 = severe. The overall range of the mMS is from 0 to 9 with a higher score indicating a worsening of the symptoms.

Time frame: Up to Week 12

Secondary Outcomes

Endoscopic remission (defined as centrally-read ESS of 0)

The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.

Time frame: Up to Week 12

Clinical response (defined as a decrease from baseline in mMS ≥2 and at least a 30% reduction from baseline, and a decrease in RBS of ≥1 or an absolute RBS of 0 or 1)

Time frame: Up to Week 12

Endoscopic improvement (defined as centrally-read ESS of 0 or 1)

The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.

Time frame: Up to Week 12

Modified Mayo Score change from baseline

Time frame: Up to Week 12

Stool frequency subscore of 0 or 1

The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.

Time frame: Up to Week 12

Rectal bleeding subscore of 0

The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.

Time frame: Up to Week 12

Occurrence of treatment-emergent adverse events (AEs)

Time frame: Up to Week 12 and up to Week 104