Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Placebo
Dupilumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be ≥18 years of age at the time of signing the informed consent.
Evidence of biomarker enrichment at time of screening.
Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrentlocal and central reading of the video endoscopy.
Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score componentassessment as determined by concurrent local and central reading of the videoendoscopy.
Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency scoreof ≥1 as determined by the Mayo score component assessment.
Participants with inadequate response/non-response, loss of response, or areintolerant of standard biologic therapy for their UC AND/OR Inadequate ornon-responders, have shown loss of response, or are intolerant to at least 1 of thefollowing treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA)compounds, immunomodulators, small molecules.
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Severe extensive colitis as evidenced by:
Current hospitalization
Likely to require surgery for the treatment of UC within 12 weeks of ScreeningVisit
UC limited to the rectum only or to <20 cm of the colon as determined by centralreading.
Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
Require, or required within the 2 months before screening, surgery for activegastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominalor pancreatic abscess requiring surgical drainage, or other conditions possiblyconfounding the evaluation of benefit from study agent treatment.
Has a prior medical history of eosinophilic colitis.
Participants with abdominal abscess, fulminant disease, or toxic megacolon.
Participants with intestinal failure or short bowel syndrome.
Presence of symptomatic colonic or small bowel obstruction, confirmed by objectiveradiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiographor an inability to traverse the stricture at endoscopy).
History of extensive colonic resection (eg, less than 30 cm of colon remaining) thatwould prevent adequate evaluation of the effect of study agent on clinical diseaseactivity.
History of colonic mucosal dysplasia or presence of adenomatous colonic polyps notremoved OR presence of colonic mucosal dysplasia or adenomatous colonic polyps notremoved during colonoscopy at screening visit.
If the participant has extensive colitis for ≥8 years or disease limited to leftside of colon (ie, distal to splenic flexure) for >10 years, regardless of age, acolonoscopy within 1 year of the screening visit is required to survey fordysplasia. Participants with dysplasia or cancer identified on biopsies will beexcluded.
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, orCrohn's disease or clinical findings suggestive of Crohn's disease.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number : 0320002
Buenos Aires, Ciudad De Buenos Aires 1125
ArgentinaActive - Recruiting
Investigational Site Number : 0320007
Buenos Aires, Ciudad De Buenos Aires 1028
ArgentinaActive - Recruiting
Investigational Site Number : 0320002
Caba, Ciudad De Buenos Aires C1125ABE
ArgentinaActive - Recruiting
Investigational Site Number : 0320007
Caba, Ciudad De Buenos Aires C1028AAP
ArgentinaSite Not Available
Investigational Site Number : 0320008
Caba, Ciudad De Buenos Aires C1119ACU
ArgentinaActive - Recruiting
Investigational Site Number : 0320003
Rosario, Santa Fe S2000DEJ
ArgentinaSite Not Available
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán 4000
ArgentinaActive - Recruiting
Investigational Site Number :0320004
San Miguel de Tucumán, Tucumán T4000IIH
ArgentinaActive - Recruiting
Investigational Site Number : 0320006
Mar Del Plata, 7600
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
San Miguel de Tucuman, 4000
ArgentinaSite Not Available
Investigational Site Number :0320001
San Miguel de Tucuman, T4000AXL
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
San Miguel de Tucumán, 4000
ArgentinaActive - Recruiting
Investigational Site Number : 1240007
Edmonton, Alberta T5R 1W2
CanadaActive - Recruiting
Investigational Site Number : 1240010
Scarborough, Ontario M1B 3V4
CanadaActive - Recruiting
Investigational Site Number : 1240006
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Investigational Site Number :1240006
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Investigational Site Number : 1240003
Montreal, H3G 1A4
CanadaActive - Recruiting
Investigational Site Number :1240003
Montreal, H3G1A4
CanadaActive - Recruiting
Investigational Site Number : 1520001
Concepcion, Biobío 4070038
ChileSite Not Available
Investigational Site Number :1520001
Concepcion, Biobío 4070038
ChileActive - Recruiting
Investigational Site Number : 1520001
Concepción, Biobío 4070038
ChileActive - Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 8380456
ChileActive - Recruiting
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago 8330034
ChileActive - Recruiting
Investigational Site Number : 1520005
Santiago, Reg Metropolitana De Santiago 7620001
ChileActive - Recruiting
Investigational Site Number :1520002
Santiago, Reg Metropolitana De Santiago 8380456
ChileActive - Recruiting
Investigational Site Number :1520003
Santiago, Reg Metropolitana De Santiago 8330034
ChileActive - Recruiting
Investigational Site Number :1520005
Santiago, Reg Metropolitana De Santiago 7620157
ChileActive - Recruiting
Investigational Site Number : 1520006
Santiago, 8360160
ChileActive - Recruiting
Investigational Site Number : 3920006
Nagoya, Aichi 451-8511
JapanActive - Recruiting
Investigational Site Number : 3920006
Nagoya-shi, Aichi 451-8511
JapanSite Not Available
Investigational Site Number :3920006
Nagoya-shi, Aichi 451-8511
JapanActive - Recruiting
Investigational Site Number : 3920008
Kitakyushu, Fukuoka 802-0077
JapanActive - Recruiting
Investigational Site Number : 3920008
Kitakyushu-shi, Fukuoka 802-8561
JapanSite Not Available
Investigational Site Number :3920008
Kitakyushu-shi, Fukuoka 802-8561
JapanActive - Recruiting
Investigational Site Number : 3920007
Kyoto-shi, Kyoto 605-0981
JapanSite Not Available
Investigational Site Number :3920007
Kyoto-shi, Kyoto 605-0981
JapanActive - Recruiting
Investigational Site Number : 3920010
Shimizu, Shizuoka 411-0905
JapanActive - Recruiting
Investigational Site Number : 3920010
Sunto-gun, Shizuoka 411-8611
JapanSite Not Available
Investigational Site Number :3920010
Sunto-gun, Shizuoka 411-8611
JapanActive - Recruiting
Investigational Site Number : 3920004
Bunkyo, Tokyo 113-8510
JapanActive - Recruiting
Investigational Site Number : 3920004
Bunkyo-ku, Tokyo 113-8519
JapanSite Not Available
Investigational Site Number :3920004
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Investigational Site Number : 3920011
Kamakura, 247-0056
JapanActive - Recruiting
Investigational Site Number : 3920011
Kamakura-shi, 247-0056
JapanSite Not Available
Investigational Site Number :3920011
Kamakura-shi, 247-0056
JapanActive - Recruiting
Investigational Site Number : 3920005
Kashiwa, 277-0871
JapanActive - Recruiting
Investigational Site Number : 3920005
Kashiwa-shi, 277-0871
JapanSite Not Available
Investigational Site Number :3920005
Kashiwa-shi, 277-0871
JapanActive - Recruiting
Investigational Site Number : 3920007
Kyoto, 605-0981
JapanActive - Recruiting
Investigational Site Number : 3920009
Saitama, 336-0963
JapanActive - Recruiting
Investigational Site Number : 3920009
Saitama-shi, 336-0963
JapanSite Not Available
Investigational Site Number :3920009
Saitama-shi, 336-0963
JapanActive - Recruiting
Investigational Site Number : 3920001
Sapporo, 065-0033
JapanActive - Recruiting
Investigational Site Number : 3920002
Sapporo, 004-0041
JapanActive - Recruiting
Investigational Site Number : 3920001
Sapporo-shi, 065-0033
JapanSite Not Available
Investigational Site Number : 3920002
Sapporo-shi, 004-0041
JapanActive - Recruiting
Investigational Site Number :3920001
Sapporo-shi, 065-0033
JapanActive - Recruiting
Investigational Site Number :3920002
Sapporo-shi, 004-0041
JapanActive - Recruiting
Investigational Site Number : 4100003
Busan, Busan-gwangyeoksi 48108
Korea, Republic ofSite Not Available
Investigational Site Number : 4100003
Haeundae-gu, Busan-gwangyeoksi 48108
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100004
Daegu, Daegu-gwangyeoksi 42415
Korea, Republic ofActive - Recruiting
Investigational Site Number :4100004
Daegu, Daegu-gwangyeoksi 705-717
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100002
Wonju, Gangwon-do 26426
Korea, Republic ofSite Not Available
Investigational Site Number :4100002
Wonju, Gangwon-do 26426
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100002
Wonju-si, Gangwon-do 26426
Korea, Republic ofActive - Recruiting
Investigational Site Number :4100003
Busan, Gwangyeoksi 48108
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100005
Daegu, 41944
Korea, Republic ofActive - Recruiting
Investigational Site Number :4100005
Daegu, 41944
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100006
Daejeon, 34943
Korea, Republic ofActive - Recruiting
Investigational Site Number :4100006
Daejeon,
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4840004
Cdmx, Ciudad De Mexico 01120
MexicoSite Not Available
Investigational Site Number : 4840004
Mexico City, Ciudad De Mexico 01120
MexicoActive - Recruiting
Investigational Site Number : 4840005
Saltillo, Coahuila De Zaragoza 25020
MexicoActive - Recruiting
Investigational Site Number : 4840002
Torreon, Coahuila De Zaragoza 27090
MexicoSite Not Available
Investigational Site Number : 4840002
Torreón, Coahuila De Zaragoza 27000
MexicoActive - Recruiting
Investigational Site Number : 4840007
Guadalajara, Jalisco 44100
MexicoActive - Recruiting
Investigational Site Number : 4840003
Chihuahua, 31000
MexicoActive - Recruiting
Gastroenterology Research Unit, UPR Medical Sciences Campus Site Number : 6300002
San Juan, 00935
Puerto RicoActive - Recruiting
University of Puerto Rico - Medical Sciences Campus- Site Number : 6300002
San Juan, 00936
Puerto RicoActive - Recruiting
Investigational Site Number : 7100002
Cape Town, 7708
South AfricaActive - Recruiting
Investigational Site Number : 7100005
Cape Town, 7405
South AfricaActive - Recruiting
Investigational Site Number : 7100007
Cape Town, 7800
South AfricaActive - Recruiting
Investigational Site Number : 7100009
Cape Town, 7500
South AfricaActive - Recruiting
Investigational Site Number :7100002
Cape Town, 7708
South AfricaActive - Recruiting
Investigational Site Number :7100005
Cape Town, 7441
South AfricaActive - Recruiting
Investigational Site Number : 7100003
Gqeberha, 6045
South AfricaActive - Recruiting
Investigational Site Number : 7100001
Johannesburg, 2017
South AfricaActive - Recruiting
Investigational Site Number : 7100006
Johannesburg, 1821
South AfricaActive - Recruiting
Investigational Site Number : 7100008
Johannesburg, 1619
South AfricaActive - Recruiting
Investigational Site Number : 7100008
Kempton Park, 1619
South AfricaSite Not Available
Investigational Site Number :7100008
Kempton Park, 1619
South AfricaActive - Recruiting
Investigational Site Number : 7100003
Port Elizabeth, 6001
South AfricaSite Not Available
Investigational Site Number :7100003
Port Elizabeth, 6001
South AfricaActive - Recruiting
Investigational Site Number : 7100004
Pretoria, 0002
South AfricaActive - Recruiting
Investigational Site Number :7100004
Pretoria, 0002
South AfricaActive - Recruiting
Investigational Site Number : 1580002
Taichung, 404
TaiwanSite Not Available
Investigational Site Number :1580002
Taichung, 40447
TaiwanActive - Recruiting
Investigational Site Number : 7920001
Akdeniz, 33070
TurkeyActive - Recruiting
Investigational Site Number : 7920002
Ankara, 06560
TurkeySite Not Available
Investigational Site Number : 7920003
Gaziantep, 27310
TurkeyActive - Recruiting
Investigational Site Number : 7920004
Istanbul, 34303
TurkeySite Not Available
Investigational Site Number : 7920005
Istanbul, 34734
TurkeyActive - Recruiting
Investigational Site Number : 7920001
Mersin, 33169
TurkeySite Not Available
Investigational Site Number : 7920006
Zonguldak, 67000
TurkeyActive - Recruiting
Om Research Site Number : 8400029
Apple Valley, California 92307
United StatesActive - Recruiting
Om Research- Site Number : 8400029
Apple Valley, California 92307
United StatesActive - Recruiting
Om Research-Site Number:8400029
Apple Valley, California 92307
United StatesActive - Recruiting
TLC Clinical Research- Site Number : 8400020
Beverly Hills, California 90211
United StatesActive - Recruiting
Om Research Site Number : 8400028
Camarillo, California 93012
United StatesActive - Recruiting
Om Research- Site Number : 8400028
Camarillo, California 93012
United StatesActive - Recruiting
Om Research-Site Number:8400028
Camarillo, California 93012
United StatesActive - Recruiting
Ventura County Gastroenterology Medical Group- Site Number : 8400028
Camarillo, California 93012
United StatesActive - Recruiting
TLC Clinical Research Inc Site Number : 8400020
Los Angeles, California 90048
United StatesSite Not Available
TLC Clinical Research Inc-Site Number:8400020
Los Angeles, California 90048
United StatesActive - Recruiting
Palmtree Clinical Research- Site Number : 8400048
Palm Springs, California 92262
United StatesActive - Recruiting
Clinical Trials Management Service Site Number : 8400034
Thousand Oaks, California 91360
United StatesActive - Recruiting
Clinical Trials Management Service- Site Number : 8400034
Thousand Oaks, California 91360
United StatesActive - Recruiting
Clinical Trials Management Service-Site Number:8400034
Thousand Oaks, California 91360
United StatesActive - Recruiting
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034
Thousand Oaks, California 91360
United StatesActive - Recruiting
Homestead Associates Site Number : 8400004
Miami, Florida 33032
United StatesActive - Recruiting
Homestead Associates in Research- Site Number : 8400004
Miami, Florida 33033
United StatesActive - Recruiting
Homestead Associates-Site Number:8400004
Miami, Florida 33032
United StatesActive - Recruiting
Wellness Clinical Research (WCR) Site Number : 8400009
Miami Lakes, Florida 33016
United StatesActive - Recruiting
Wellness Clinical Research (WCR)-Site Number:8400009
Miami Lakes, Florida 33016
United StatesActive - Recruiting
Wellness Clinical Research - Miami Lakes- Site Number : 8400009
Miami Lakes, Florida 33016
United StatesActive - Recruiting
GI PROS Research- Site Number : 8400046
Naples, Florida 34102
United StatesActive - Recruiting
Advanced Research Institute - New Port Richey- Site Number : 8400026
New Port Richey, Florida 34653
United StatesActive - Recruiting
Advanced Research Institute, Inc. Site Number : 8400026
New Port Richey, Florida 34653
United StatesActive - Recruiting
Advanced Research Institute, Inc.-Site Number:8400026
New Port Richey, Florida 34653
United StatesActive - Recruiting
Digestive Disease Consultants - Orange Park- Site Number : 8400042
Orange Park, Florida 32073
United StatesSite Not Available
Digestive Disease Consultants Site Number : 8400042
Orange Park, Florida 32073
United StatesActive - Recruiting
Digestive Disease Consultants- Site Number : 8400042
Orange Park, Florida 32073
United StatesActive - Recruiting
Tellabio International Research Services Site Number : 8400041
Pembroke Pines, Florida 33025
United StatesActive - Recruiting
Tellabio International Research Services- Site Number : 8400041
Pembroke Pines, Florida 33025
United StatesActive - Recruiting
AdtreMed Site Number : 8400035
Tampa, Florida 33607
United StatesActive - Recruiting
AdtreMed- Site Number : 8400035
Tampa, Florida 33607
United StatesActive - Recruiting
AdtreMed-Site Number:8400035
Tampa, Florida 33607
United StatesActive - Recruiting
GCP Clinical Research Site Number : 8400014
Tampa, Florida 33609
United StatesActive - Recruiting
GCP Clinical Research- Site Number : 8400014
Tampa, Florida 33609
United StatesActive - Recruiting
GCP Clinical Research-Site Number:8400014
Tampa, Florida 33609
United StatesActive - Recruiting
Gastroenterology Consultants - Roswell- Site Number : 8400022
Roswell, Georgia 30076
United StatesActive - Recruiting
Gastroenterology Consultants PC Site Number : 8400022
Roswell, Georgia 30078
United StatesActive - Recruiting
Gastroenterology Consultants PC-Site Number:8400022
Roswell, Georgia 30078
United StatesActive - Recruiting
Gastro Center of Maryland Site Number : 8400021
Columbia, Maryland 21045
United StatesActive - Recruiting
Gastro Center of Maryland- Site Number : 8400021
Columbia, Maryland 21045
United StatesSite Not Available
Gastro Center of Maryland-Site Number:8400021
Columbia, Maryland 21045
United StatesActive - Recruiting
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043
East Orange, New Jersey 07018
United StatesActive - Recruiting
Sanmora Bespoke Clinical Research- Site Number : 8400043
East Orange, New Jersey 07018
United StatesActive - Recruiting
Smart Medical Research Inc Site Number : 8400037
Jackson Heights, New York 11372
United StatesActive - Recruiting
Smart Medical Research Inc- Site Number : 8400037
Jackson Heights, New York 11372
United StatesActive - Recruiting
DiGiovanna Family Care- Site Number : 8400006
Massapequa, New York 11758
United StatesActive - Recruiting
DiGiovanna Institute for Medical Education and Research Site Number : 8400006
North Massapequa, New York 11758-1802
United StatesSite Not Available
DiGiovanna Institute for Medical Education and Research-Site Number:8400006
North Massapequa, New York 11758-1802
United StatesActive - Recruiting
Javara Research Site Number : 8400008
Charlotte, North Carolina 28287
United StatesActive - Recruiting
Javara Research-Site Number:8400008
Charlotte, North Carolina 28287
United StatesActive - Recruiting
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008
Charlotte, North Carolina 28287
United StatesActive - Recruiting
Care Access - Lumberton- Site Number : 8400018
Lumberton, North Carolina 28358
United StatesCompleted
Care Access Research, Lumberton Site Number : 8400018
Lumberton, North Carolina 28358
United StatesCompleted
Care Access Research, Lumberton- Site Number : 8400018
Lumberton, North Carolina 28358
United StatesCompleted
Care Access Research, Lumberton-Site Number:8400018
Lumberton, North Carolina 28358
United StatesActive - Recruiting
Care Access Research, Youngstown Site Number : 8400015
Poland, Ohio 44514
United StatesSite Not Available
Care Access Research, Youngstown-Site Number:8400015
Poland, Ohio 44514
United StatesActive - Recruiting
Digestive Disorders Centers Site Number : 8400038
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Digestive Disorders Centers- Site Number : 8400038
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
University of Pittsburgh Medical Center- Site Number : 8400038
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Gastroenterology Associates - Patewood- Site Number : 8400012
Greenville, South Carolina 29607
United StatesSite Not Available
Gastroenterology Associates, P.A. Site Number : 8400012
Greenville, South Carolina 29607
United StatesActive - Recruiting
Gastroenterology Associates, P.A.-Site Number:8400012
Greenville, South Carolina 29607
United StatesActive - Recruiting
Advanced Gastroenterology Associates, PA- Site Number : 8400047
Decatur, Texas 76234
United StatesActive - Recruiting
Katy Integrative Gastroenterology Site Number : 8400027
Katy, Texas 77494
United StatesActive - Recruiting
Katy Integrative Gastroenterology- Site Number : 8400027
Katy, Texas 77494
United StatesActive - Recruiting
Katy Integrative Gastroenterology-Site Number:8400027
Katy, Texas 77494
United StatesActive - Recruiting
Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039
Sherman, Texas 75092
United StatesActive - Recruiting
Medrasa Clinical Research Site Number : 8400039
Sherman, Texas 75092
United StatesActive - Recruiting
Medrasa Clinical Research- Site Number : 8400039
Sherman, Texas 75092
United StatesActive - Recruiting
Medrasa Clinical Research-Site Number:8400039
Sherman, Texas 75092
United StatesActive - Recruiting
GI Alliance - Southlake Site Number : 8400013
Southlake, Texas 76092
United StatesActive - Recruiting
GI Alliance - Southlake-Site Number:8400013
Southlake, Texas 76092
United StatesActive - Recruiting
Texas Digestive Disease Consultants - Southlake- Site Number : 8400013
Southlake, Texas 76092
United StatesActive - Recruiting
Digestive Health Specialists of Tyler- Site Number : 8400031
Tyler, Texas 75701
United StatesActive - Recruiting
Tyler Research Institute Site Number : 8400031
Tyler, Texas 75701
United StatesActive - Recruiting
Tyler Research Institute-Site Number:8400031
Tyler, Texas 75701
United StatesActive - Recruiting
Gastro Health & Nutrition Site Number : 8400019
Victoria, Texas 77904
United StatesActive - Recruiting
Gastro Health & Nutrition-Site Number:8400019
Victoria, Texas 77904
United StatesActive - Recruiting
Victoria Gastroenterology- Site Number : 8400019
Victoria, Texas 77904
United StatesActive - Recruiting
Gastroenterology Associates - Manassas- Site Number : 8400032
Manassas, Virginia 20110
United StatesSite Not Available
Gastroenterology Associates, PC Site Number : 8400032
Manassas, Virginia 20120
United StatesActive - Recruiting
Washington Gastroenterology - Bellevue- Site Number : 8400025
Bellevue, Washington 98004
United StatesActive - Recruiting
Washington Gastroenterology Site Number : 8400025
Bellevue, Washington 98004
United StatesActive - Recruiting
Washington Gastroenterology-Site Number:8400025
Bellevue, Washington 98004
United StatesActive - Recruiting
Washington Gastroenterology - Tacoma- Site Number : 8400030
Tacoma, Washington 98405
United StatesActive - Recruiting
Washington Gastroenterology Site Number : 8400030
Tacoma, Washington 98405
United StatesActive - Recruiting
Washington Gastroenterology- Site Number : 8400030
Tacoma, Washington 98405
United StatesActive - Recruiting
Washington Gastroenterology-Site Number:8400030
Tacoma, Washington 98405
United StatesActive - Recruiting
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