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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509544-10-00 | Registry Identifier | CTIS (EU) | |
| U1111-1300-3640 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants will receive an intravenous dose of BI 3032950 in Part A followed by a subcutaneous dose of BI 3032950 in Part B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3032950 intravenous (Part A) | Drug | BI 3032950 intravenous (Part A) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| One of a Kind Clinical Research Center | Not yet recruiting | Scottsdale | Arizona | 85258 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a "Document Sharing Agreement". For study data -
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The study consists of Part A and Part B.
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| BI 3032950 subcutaneous (Part B) |
| Drug |
BI 3032950 subcutaneous (Part B) |
|
The modified Mayo score (mMS) consists of 3 components
|
| 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. | Up to Week 12 |
| Modified Mayo Score change from baseline | The modified Mayo score (mMS) consists of 3 components
| 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. | 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. | Up to Week 12 |
| Occurrence of treatment-emergent adverse events (AEs) | Up to Week 12 and up to Week 104 |
| Peak Gastroenterology Associates | Recruiting | Colorado Springs | Colorado | 80907 | United States |
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| Clinical Research of Osceola | Not yet recruiting | Kissimmee | Florida | 34741 | United States |
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| Florida Research Institute | Recruiting | Lakewood Rch | Florida | 34211 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Reliant Medical Research | Recruiting | Miami | Florida | 33165-3639 | United States |
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| Illinois Gastroenterology Group - Gurnee | Recruiting | Gurnee | Illinois | 60031 | United States |
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| University of Kansas Medical Center | Not yet recruiting | Kansas City | Kansas | 66103-2937 | United States |
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| Columbia University Medical Center | Not yet recruiting | New York | New York | 10032-3725 | United States |
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| Atrium Health Gastroenterology and Hepatology | Recruiting | Charlotte | North Carolina | 28204-2963 | United States |
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| Texas Digestive Disease Consultants | Recruiting | Cedar Park | Texas | 78613 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| University of Washington | Not yet recruiting | Seattle | Washington | 98195-0001 | United States |
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| Digestive Health Specialists | Recruiting | Tacoma | Washington | 98405-2318 | United States |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| CHC MontLegia | Recruiting | Liège | 4000 | Belgium |
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| Hepato-Gastroenterologie HK, s.r.o. | Not yet recruiting | Hradec Králové | 500 12 | Czechia |
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| ISCARE a.s. | Recruiting | Prague | 190 00 | Czechia |
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| Centrum Medyczne Plejady | Recruiting | Krakow | 30-363 | Poland |
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| Medrise Sp. z o.o. | Not yet recruiting | Lublin | 20-582 | Poland |
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| Eskulap Pabianice Sp. z o.o. | Not yet recruiting | Pabianice | 95-200 | Poland |
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| EMC Instytut Medyczny S.A. - Poznan 70-304 | Recruiting | Poznan | 60-309 | Poland |
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| Clinical Research Center Sp. z o.o. Medic-R sp.k. | Recruiting | Poznan | 61-731 | Poland |
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| Centrum Medyczne Medyk Sp. z o.o. | Not yet recruiting | Rzeszów | 35-326 | Poland |
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| Endoskopia Sp. z o.o. | Recruiting | Sopot | 81-756 | Poland |
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| Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. | Recruiting | Szczecin | 71-434 | Poland |
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| Gastromed Sp. z o.o. | Not yet recruiting | Torun | 87-100 | Poland |
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| Synexus Polska Sp. z o.o. | Recruiting | Warsaw | 02-672 | Poland |
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| NZOZ VIVAMED Jadwiga Miecz | Not yet recruiting | Warsaw | 03-580 | Poland |
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| PlanetMed Sp. z o.o. | Recruiting | Wroclaw | 52-210 | Poland |
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| EMC Instytut Medyczny S.A. - Wroclaw | Recruiting | Wroclaw | 54-239 | Poland |
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| Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. | Not yet recruiting | Włocławek | 87-800 | Poland |
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| Pro Life Medica Sp. z o.o. | Recruiting | Zamość | 22-400 | Poland |
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| Clinical Hospital Center Zvezdara | Recruiting | Belgrade | 11000 | Serbia |
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| Military Medical Academy | Not yet recruiting | Belgrade | 11040 | Serbia |
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| Clinical Center Zemun | Not yet recruiting | Belgrade | 11080 | Serbia |
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| General Hospital - Djordje Joanovic | Recruiting | Zrenjanin | 23101 | Serbia |
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| F D Roosevelt University General Hospital Of Banska Bystrica | Recruiting | Banská Bystrica | 975 17 | Slovakia |
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| ENDOMED s.r.o. | Recruiting | Košice | 040 13 | Slovakia |
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| KM Management, spol. s.r.o. | Recruiting | Nitra | 949 01 | Slovakia |
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| Gastro I., s.r.o | Recruiting | Prešov | 080 01 | Slovakia |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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