Phase
Condition
Colic
Crohn's Disease
Ulcers
Treatment
BI 3032950 intravenous (Part A)
BI 3032950 subcutaneous (Part B)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
Further inclusion criteria apply.
Exclusion criteria
Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
Evidence of fulminant colitis or toxic megacolon at screening,
Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
Further exclusion criteria apply.
Study Design
Connect with a study center
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
AZ Maria Middelares
Gent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Clinique CHC Montlégia
Liège, 4000
BelgiumActive - Recruiting
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, 50012
CzechiaSite Not Available
University Hospital Ostrava
Ostrava, 708 52
CzechiaSite Not Available
ISCARE a.s.
Praha 9, 190 00
CzechiaActive - Recruiting
Centrum Medyczne Medis
Bydgoszcz, 85-168
PolandSite Not Available
Centrum Medyczne Plejady
Krakow, 30-363
PolandActive - Recruiting
Eskulap Pabianice Sp. Z o.o.
Lodz, 91-363
PolandSite Not Available
Healthcare Center Gastromed - SCANMED GROUP
Lublin, 20-582
PolandSite Not Available
Medrise Sp. z o.o.
Lublin, 20-582
PolandSite Not Available
Clinical Research Center
Poznan, 60-848
PolandActive - Recruiting
Clinical Research Center Sp. z o.o. Medic-R sp. k.
Poznan, 60-848
PolandActive - Recruiting
EMC Instytut Medyczny S.A.-Poznan-70304
Poznan, 60-309
PolandActive - Recruiting
Medical Center Medyk
Rzeszow, 35-326
PolandSite Not Available
Endoskopia Sp. z o.o.
Sopot, 81-756
PolandActive - Recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
PolandActive - Recruiting
Gastromed Sp. z o.o.
Torun, 87-100
PolandSite Not Available
Non-Public Outpatient Medical Care VIVAMED, Warsaw
Warsaw, 03-580
PolandSite Not Available
Synexus Polska Sp. z o.o.
Warszawa, 02-672
PolandActive - Recruiting
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
Wloclawek, 87-800
PolandSite Not Available
EMC Instytut Medyczny S.A.-Wroclaw-70301
Wroclaw, 54-144
PolandActive - Recruiting
PlanetMed Sp. z o.o.
Wroclaw, 52-210
PolandSite Not Available
ETG Zamosc
Zamosc, 22-400
PolandActive - Recruiting
Clinical Center Zemun
Belgrade, 11080
SerbiaSite Not Available
Clinical Hospital Center Dr. Dragisa Misovic
Belgrade, 11000
SerbiaSite Not Available
Clinical Medical Center Zvezdara, Belgrade
Belgrade, 11000
SerbiaSite Not Available
Military Medical Academy
Belgrade, 11000
SerbiaSite Not Available
University Clinical Center of Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
General Hospital - Djordje Joanovic
Zrenjanin, 23101
SerbiaActive - Recruiting
FNsP F.D.R. Banska Bystrica
Banska Bystrica, 975 17
SlovakiaSite Not Available
ENDOMED s.r.o.
Kosice, 040 13
SlovakiaSite Not Available
KM Management, spol. s.r.o.
Nitra, 949 01
SlovakiaSite Not Available
Gastro I., s.r.o
Presov, 8001
SlovakiaActive - Recruiting
Accout Center s.r.o.
Sahy, 93601
SlovakiaSite Not Available
Future Innovative Treatments
Colorado Springs, Colorado 80907
United StatesSite Not Available
Future Innovative Treatments, LLC
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Medical Research Center of Connecticut, LLC
New Haven, Connecticut 06518-3691
United StatesSite Not Available
Florida Research Institute
Lakewood Ranch, Florida 34211
United StatesActive - Recruiting
Medical Professional Clinical Research
Miami, Florida 33165
United StatesSite Not Available
Reliant Medical Research
Miami, Florida 33165-3639
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Illinois Gastroenterology Group - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66103-2937
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032-3725
United StatesSite Not Available
Atrium Health
Charlotte, North Carolina 28204-2963
United StatesSite Not Available
Wake Research Associates
Raleigh, North Carolina 27612
United StatesSite Not Available
Texas Digestive Disease Consultants
Cedar Park, Texas 78613
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
GI Alliance
Mansfield, Texas 76063
United StatesSite Not Available
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesSite Not Available
University of Washington
Seattle, Washington 98195-0001
United StatesSite Not Available
Digestive Health Specialists
Tacoma, Washington 98405-2318
United StatesActive - Recruiting
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