A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))
Launched by SANOFI · Feb 15, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called LIBERTY-UC SUCCEED, is investigating the effectiveness and safety of a medication called dupilumab for adults aged 18 and older who have moderately to severely active ulcerative colitis (UC), particularly those with a specific type known as the eosinophilic phenotype. The study will compare dupilumab to a placebo, which is a substance with no active ingredients, to see how well it works over a period of 52 weeks. Participants will initially go through a screening phase of 2 to 4 weeks, followed by treatment with either dupilumab or a placebo, and then a 12-week follow-up period.
To be eligible for this trial, participants must have a confirmed diagnosis of moderately to severely active UC and show specific symptoms, such as rectal bleeding. They should be 18 years or older and have had an inadequate response or intolerance to standard treatments for UC. However, individuals with severe complications or other specific health conditions cannot participate. Throughout the study, participants will receive regular check-ups to monitor their health and any side effects from the treatment. This trial is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they qualify.
Gender
ALL
Eligibility criteria
- 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 concurrent local and central reading of the video endoscopy.
- • Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
- • Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment.
- • Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC AND/OR Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA) compounds, immunomodulators, small molecules.
- 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 Screening Visit
- • UC limited to the rectum only or to \<20 cm of the colon as determined by central reading.
- • 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 active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding 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 objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
- • History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.
- • History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit.
- • If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
- • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn'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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taichung, , Taiwan
Bunkyo Ku, Tokyo, Japan
San Miguel De Tucuman, , Argentina
Wonju, Gangwon Do, Korea, Republic Of
Miami Lakes, Florida, United States
Charlotte, North Carolina, United States
North Massapequa, New York, United States
Lumberton, North Carolina, United States
Poland, Ohio, United States
Kashiwa Shi, , Japan
Busan, , Korea, Republic Of
Apple Valley, California, United States
Los Angeles, California, United States
Miami, Florida, United States
Columbia, Maryland, United States
Southlake, Texas, United States
Bellevue, Washington, United States
Tacoma, Washington, United States
Montreal, Quebec, Canada
Montreal, , Canada
Concepcion, Biobío, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Nagoya Shi, Aichi, Japan
Kyoto Shi, Kyoto, Japan
Kamakura Shi, , Japan
Sapporo Shi, , Japan
Sapporo Shi, , Japan
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Daegu, , Korea, Republic Of
New Port Richey, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Greenville, South Carolina, United States
Santiago, Reg Metropolitana De Santiago, Chile
Saitama Shi, , Japan
Daejeon, , Korea, Republic Of
Camarillo, California, United States
Katy, Texas, United States
Tyler, Texas, United States
Victoria, Texas, United States
Kitakyushu Shi, Fukuoka, Japan
Sunto Gun, Shizuoka, Japan
Cape Town, , South Africa
Cape Town, , South Africa
Port Elizabeth, , South Africa
Thousand Oaks, California, United States
Tampa, Florida, United States
Sherman, Texas, United States
San Miguel De Tucumán, Tucumán, Argentina
Busan, Gwangyeoksi, Korea, Republic Of
Kempton Park, , South Africa
Pretoria, , South Africa
Rosario, Santa Fe, Argentina
Wonju, Gangwon Do, Korea, Republic Of
Chihuahua, , Mexico
Taichung, , Taiwan
Apple Valley, California, United States
Camarillo, California, United States
Los Angeles, California, United States
Thousand Oaks, California, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Columbia, Maryland, United States
Jackson Heights, New York, United States
North Massapequa, New York, United States
Charlotte, North Carolina, United States
Lumberton, North Carolina, United States
Poland, Ohio, United States
Greenville, South Carolina, United States
Katy, Texas, United States
Sherman, Texas, United States
Southlake, Texas, United States
Tyler, Texas, United States
Victoria, Texas, United States
Manassas, Virginia, United States
Bellevue, Washington, United States
Tacoma, Washington, United States
Caba, Ciudad De Buenos Aires, Argentina
San Miguel De Tucumán, Tucumán, Argentina
San Miguel De Tucuman, , Argentina
Montreal, Quebec, Canada
Montreal, , Canada
Concepcion, Biobío, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Nagoya Shi, Aichi, Japan
Kitakyushu Shi, Fukuoka, Japan
Kyoto Shi, Kyoto, Japan
Sunto Gun, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Kamakura Shi, , Japan
Kashiwa Shi, , Japan
Saitama Shi, , Japan
Sapporo Shi, , Japan
Sapporo Shi, , Japan
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Busan, Gwangyeoksi, Korea, Republic Of
Daegu, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Torreon, Coahuila De Zaragoza, Mexico
San Juan, , Puerto Rico
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Ankara, , Turkey
Gaziantep, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Mersin, , Turkey
Zonguldak, , Turkey
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Mar Del Plata, , Argentina
Busan, Busan Gwangyeoksi, Korea, Republic Of
Cdmx, Ciudad De Mexico, Mexico
Saltillo, Coahuila De Zaragoza, Mexico
Cape Town, , South Africa
Johannesburg, , South Africa
Guadalajara, Jalisco, Mexico
San Miguel De Tucumán, Tucumán, Argentina
Santiago, , Chile
Orange Park, Florida, United States
Pembroke Pines, Florida, United States
Pittsburgh, Pennsylvania, United States
Caba, Ciudad De Buenos Aires, Argentina
Edmonton, Alberta, Canada
Cape Town, , South Africa
Johannesburg, , South Africa
San Miguel De Tucuman, , Argentina
San Miguel De Tucumán, , Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Akdeniz, , Turkey
Apple Valley, California, United States
Beverly Hills, California, United States
Camarillo, California, United States
Thousand Oaks, California, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orange Park, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Columbia, Maryland, United States
East Orange, New Jersey, United States
Jackson Heights, New York, United States
Massapequa, New York, United States
Charlotte, North Carolina, United States
Lumberton, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Katy, Texas, United States
Sherman, Texas, United States
Southlake, Texas, United States
Tyler, Texas, United States
Victoria, Texas, United States
Manassas, Virginia, United States
Bellevue, Washington, United States
Tacoma, Washington, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Scarborough, Ontario, Canada
Montreal, , Canada
Concepción, Biobío, Chile
Nagoya, Aichi, Japan
Kitakyushu, Fukuoka, Japan
Shimizu, Shizuoka, Japan
Bunkyo, Tokyo, Japan
Kamakura, , Japan
Kashiwa, , Japan
Kyoto, , Japan
Saitama, , Japan
Sapporo, , Japan
Sapporo, , Japan
Haeundae Gu, Busan Gwangyeoksi, Korea, Republic Of
Wonju Si, Gangwon Do, Korea, Republic Of
Daejeon, , Korea, Republic Of
Mexico City, Ciudad De Mexico, Mexico
Torreón, Coahuila De Zaragoza, Mexico
San Juan, , Puerto Rico
Gqeberha, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Taichung, , Taiwan
Gaziantep, , Turkey
Zonguldak, , Turkey
Mar Del Plata, , Argentina
Camarillo, California, United States
Thousand Oaks, California, United States
Orange Park, Florida, United States
Lumberton, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Tacoma, Washington, United States
Palm Springs, California, United States
Miami, Florida, United States
East Orange, New Jersey, United States
Sherman, Texas, United States
Caba, Ciudad De Buenos Aires, Argentina
Naples, Florida, United States
Greenville, South Carolina, United States
Decatur, Texas, United States
Buenos Aires, , Argentina
Pittsburgh, Pennsylvania, United States
Mar Del Plata, Buenos Aires, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Montreal, Quebec, Canada
Santiago, Reg Metropolitana De Santiago, Chile
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kamakura, Kanagawa, Japan
Daegu, Daegu Gwangyeoksi, Korea, Republic Of
Daejeon, Daejeon Gwangyeoksi, Korea, Republic Of
Daegu, Gyeongsangbuk Do, Korea, Republic Of
San Miguel De Tucumán, , Argentina
Concepción, , Chile
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials