A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis (NCT06636656)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: One of a Kind Clinical Research Center — Scottsdale, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- One of a Kind Clinical Research Center — Scottsdale, Arizona
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- Primary Care of Osceola — Kissimmee, Florida
- Florida Research Institute — Lakewood Rch, Florida
- University of Miami — Miami, Florida
- Reliant Medical Research — Miami, Florida
- Illinois Gastroenterology Group - Gurnee — Gurnee, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- Columbia University Medical Center — New York, New York
- Atrium Health Gastroenterology and Hepatology — Charlotte, North Carolina
- Texas Digestive Disease Consultants — Cedar Park, Texas
- Baylor College of Medicine — Houston, Texas
- University of Washington — Seattle, Washington
- Digestive Health Specialists — Tacoma, Washington
- UZ Leuven — Leuven,
- CHC MontLegia — Liège,
- Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové,
- ISCARE a.s. — Prague,
- Centrum Medyczne Plejady — Krakow,
- Medrise Sp. z o.o. — Lublin,
- Eskulap Pabianice Sp. z o.o. — Pabianice,
- EMC Instytut Medyczny S.A. - Poznan 70-304 — Poznan,
- Clinical Research Center Sp. z o.o. Medic-R sp.k. — Poznan,
- Centrum Medyczne Medyk Sp. z o.o. — Rzeszów,
- Endoskopia Sp. z o.o. — Sopot,
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.