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

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• BI 3032950 intravenous (Part A) — DRUG
  BI 3032950 intravenous (Part A)
• BI 3032950 subcutaneous (Part B) — DRUG
  BI 3032950 subcutaneous (Part B)

Study Details

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.

Key Dates

Start date

Dec 11, 2024

Status verified

May 2026

Primary completion

Jul 30, 2027

Completion

Jul 30, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

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

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (14)

Find similar trials in Scottsdale, AZ

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