Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must voluntarily sign and date an informed consent, approved by anindependent ethics committee (IEC)/institutional review board (IRB), prior to theinitiation of any screening or study-specific procedures.
- Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation ofbiopsy results consistent with the diagnosis of UC in the assessment of theInvestigator, must be available.
- Participant meets the following disease activity criteria: Active UC with an AdaptedMayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by centralreview).
- History of inadequate response, loss of response, or intolerance to one or more of theapproved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/ortofacitinib (Note: If tofacitinib was received in a clinical trial, subject must havereceived open-label drug).
Exclusion
Exclusion Criteria:
- Participant having an active, chronic, or recurrent infection that based onInvestigator's clinical assessment makes the participant an unsuitable candidate forthe study.
- Participant having any malignancy except for successfully treated non-metastaticcutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of thecervix.
- Participant with history of dysplasia of the gastrointestinal tract or evidence ofdysplasia in any biopsy performed during the screening endoscopy other than completelyremoved low-grade dysplastic lesions.
- Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total whiteblood cell (WBC) count >= 3.0*10^9/L.
Study Design
Connect with a study center
Zeidler Ledcor Centre /ID# 205069
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Mount Sinai Hospital /ID# 206180
Toronto, Ontario M5G 1X5
CanadaSite Not Available
Montreal General Hospital /ID# 204732
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Montreal General Hospital /ID# 204732
Montréal, Quebec H3G 1A4
CanadaSite Not Available
Chu de Nice-Hopital L'Archet Ii /Id# 208131
Nice, Alpes-Maritimes 06200
FranceSite Not Available
Chu de Nice-Hopital L'Archet Ii /Id# 208131
Nice CEDEX 3, Alpes-Maritimes 06202
FranceSite Not Available
CHRU Lille - Hôpital Claude Huriez /ID# 208132
Lille CEDEX, Hauts-de-France 59045
FranceSite Not Available
Hopital Beaujon /ID# 208129
Clichy, Ile-de-France 92110
FranceSite Not Available
CHU NANCY - Hopital Brabois Adultes /ID# 208133
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle 54511
FranceSite Not Available
CHRU Nancy - Hôpitaux de Brabois /ID# 208133
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500
FranceSite Not Available
Universitaetsklinikum Frankfurt /ID# 207569
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
Kiel, Schleswig-Holstein 24105
GermanySite Not Available
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
Berlin, 10117
GermanySite Not Available
Universitaetklinikum Dresden /ID# 209962
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Frankfurt /ID# 207569
Frankfurt, 60590
GermanySite Not Available
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
Szeged, Csongrad 6725
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont /ID# 221952
Debrecen, 4032
HungarySite Not Available
University of Catanzaro /ID# 204546
Catanzaro, Calabria 88100
ItalySite Not Available
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
Rome, Roma 00168
ItalySite Not Available
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
Milan, 20122
ItalySite Not Available
Kyungpook National University Hospital /ID# 209912
Daegu, 41944
Korea, Republic ofSite Not Available
Yeungnam University Medical Center /ID# 210447
Daegu, 42415
Korea, Republic ofSite Not Available
Maastricht Universitair Medisch Centrum /ID# 204428
Maastricht, 6229 HX
NetherlandsSite Not Available
Franciscus Gasthuis & Vlietland /ID# 206976
Rotterdam, 3045 PM
NetherlandsSite Not Available
Elisabeth Tweesteden Ziekenhuis /ID# 206272
Tilburg, 5022 GC
NetherlandsSite Not Available
Hospital Santa Creu i Sant Pau /ID# 213259
Barcelona, 08041
SpainSite Not Available
Hosp Univ Girona Josep Trueta /ID# 208230
Girona, 17007
SpainSite Not Available
Hospital General Universitario Gregorio Maranon /ID# 204504
Madrid, 28007
SpainSite Not Available
Hospital Universitario La Paz /ID# 210065
Madrid, 28046
SpainSite Not Available
NHS Greater Glasgow and Clyde /ID# 206574
Glasgow, Scotland G12 0XH
United KingdomSite Not Available
Belfast Health and Social Care Trust /ID# 206744
Belfast, BT9 7AB
United KingdomSite Not Available
St. George's Healthcare NHS /ID# 206745
London, SW17 0QT
United KingdomSite Not Available
Banner University Medical Cent /ID# 208392
Tucson, Arizona 85724
United StatesSite Not Available
TLC Clinical Research Inc /ID# 206626
Beverly Hills, California 90211-2091
United StatesSite Not Available
Meridian Investigator Network /ID# 204646
Huntington Beach, California 92648-5994
United StatesSite Not Available
Meridian Investigator Network /ID# 218568
Lakewood, California 90712
United StatesSite Not Available
TLC Clinical Research Inc /ID# 206626
Los Angeles, California 90048
United StatesSite Not Available
Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
Mission Viejo, California 92691-6306
United StatesSite Not Available
Meridian Investigator Network /ID# 204646
Newport Beach, California 92660
United StatesSite Not Available
UC Davis Medical Center /ID# 209402
Sacramento, California 95817
United StatesSite Not Available
University of South Florida /ID# 210180
Tampa, Florida 33612
United StatesSite Not Available
The University of Chicago DCAM /ID# 207086
Chicago, Illinois 60637
United StatesSite Not Available
Chicago Association for Research and Education in Science (CARES) /ID# 208092
North Chicago, Illinois 60064-3048
United StatesSite Not Available
Affinity Clinical Research /ID# 206211
Oak Brook, Illinois 60523-1245
United StatesSite Not Available
Univ New Mexico /ID# 208817
Albuquerque, New Mexico 87131
United StatesSite Not Available
Penn Presbyterian Medical Center /ID# 206826
Philadelphia, Pennsylvania 19104-2640
United StatesSite Not Available
Vanderbilt University Medical Center /ID# 204670
Nashville, Tennessee 37232-0011
United StatesSite Not Available
Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
San Antonio, Texas 78212
United StatesSite Not Available
CHI Franciscan Research Center /ID# 205142
Tacoma, Washington 98405
United StatesSite Not Available

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