A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: BI 3032950 intravenous (Part A)Drug: BI 3032950 subcutaneous (Part B)
- Registration Number
- NCT06636656
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All participants BI 3032950 intravenous (Part A) All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B. All participants BI 3032950 subcutaneous (Part B) 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 Measures
Name Time Method 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 Up to Week 12 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.
- Secondary Outcome Measures
Name Time Method Endoscopic remission (defined as centrally-read ESS of 0) Up to Week 12 The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
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) Up to Week 12 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.Endoscopic improvement (defined as centrally-read ESS of 0 or 1) Up to Week 12 The endoscopy subscore (ESS) is graded from 0 = none to 3 = severe. The ESS is part of the modified Mayo score.
Modified Mayo Score change from baseline Up to Week 12 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.Stool frequency subscore of 0 or 1 Up to Week 12 The stool frequency (SFS) is graded from 0 = none to 3 = severe. The SFS is part of the modified Mayo score.
Rectal bleeding subscore of 0 Up to Week 12 The rectal bleeding subscore (RBS) is graded from 0 = none to 3 = severe. The RBS is part of the modified Mayo score.
Occurrence of treatment-emergent adverse events (AEs) Up to Week 12 and up to Week 104
Trial Locations
- Locations (50)
Clinical Research Center
🇵🇱Poznan, Poland
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸New Haven, Connecticut, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
Medical Professional Clinical Research
🇺🇸Miami, Florida, United States
Illinois Gastroenterology Group - Gurnee
🇺🇸Gurnee, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Texas Digestive Disease Consultants
🇺🇸Cedar Park, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
GI Alliance
🇺🇸Mansfield, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Digestive Health Specialists
🇺🇸Tacoma, Washington, United States
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Clinique CHC Montlégia
🇧🇪Liège, Belgium
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
University Hospital Ostrava
🇨🇿Ostrava, Czechia
ISCARE a.s.
🇨🇿Praha 9, Czechia
Centrum Medyczne Medis
🇵🇱Bydgoszcz, Poland
EMC Instytut Medyczny S.A.-Poznan-70304
🇵🇱Poznan, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Eskulap Pabianice Sp. Z o.o.
🇵🇱Lodz, Poland
Medrise Sp. z o.o.
🇵🇱Lublin, Poland
Medical Center Medyk
🇵🇱Rzeszow, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Gastromed Sp. z o.o.
🇵🇱Torun, Poland
Non-Public Outpatient Medical Care VIVAMED, Warsaw
🇵🇱Warsaw, Poland
Synexus Polska Sp. z o.o.
🇵🇱Warszawa, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
🇵🇱Wloclawek, Poland
PlanetMed Sp. z o.o.
🇵🇱Wroclaw, Poland
EMC Instytut Medyczny S.A.-Wroclaw-70301
🇵🇱Wroclaw, Poland
ETG Zamosc
🇵🇱Zamosc, Poland
Clinical Hospital Center Dr. Dragisa Misovic
🇷🇸Belgrade, Serbia
Clinical Medical Center Zvezdara, Belgrade
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Center Zemun
🇷🇸Belgrade, Serbia
University Clinical Center of Kragujevac
🇷🇸Kragujevac, Serbia
General Hospital - Djordje Joanovic
🇷🇸Zrenjanin, Serbia
FNsP F.D.R. Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
ENDOMED s.r.o.
🇸🇰Kosice, Slovakia
KM Management, spol. s.r.o.
🇸🇰Nitra, Slovakia
Gastro I., s.r.o
🇸🇰Presov, Slovakia
Accout Center s.r.o.
🇸🇰Sahy, Slovakia