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NCT06636656 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 20
- Study locations
NCT06636656: Active Phase 2 study of Ulcerative Colitis, sponsored by Boehringer Ingelheim.
NCT06636656 is a Phase 2 study of Ulcerative Colitis that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 45 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06636656, a Phase 2 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG BI 3032950 intravenous (Part A)
- DRUG BI 3032950 subcutaneous (Part B)
Study Locations (20)
Other
- 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
Florida
- Clinical Research of Osceola - Kissimmee
- Florida Research Institute - Lakewood Rch
- University of Miami - Miami
- Reliant Medical Research - Miami
Texas
- Texas Digestive Disease Consultants - Cedar Park
- Baylor College of Medicine - Houston
Washington
- University of Washington - Seattle
- Digestive Health Specialists - Tacoma
Arizona
- One of a Kind Clinical Research Center - Scottsdale
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Illinois
- Illinois Gastroenterology Group - Gurnee - Gurnee
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 2 |
What the registry record for NCT06636656 still lists
NCT06636656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which BI 3032950 intravenous (Part A) is the first listed.
NCT06636656 names 20 study sites across 10 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT06636656 about?
NCT06636656 is a clinical study titled "A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis". 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. ...
What is the current status of trial NCT06636656?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2024-12-11. Estimated completion is 2028-02-29.
What conditions does trial NCT06636656 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06636656?
The interventions under investigation include: BI 3032950 intravenous (Part A) (DRUG), BI 3032950 subcutaneous (Part B) (DRUG).
Who is sponsoring clinical trial NCT06636656?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06636656 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06636656's enrollment target sits among peer trials
45 90th of 122 higher than 32 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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