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))

Conditions: Colitis Ulcerative

Summary: the protocol of this phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active ulcerative colitis (uc) with an eosinophilic phenotype. screening period: 2 to up to 4 weeks treatment period: 52-week investigational medicinal product (imp) intervention (dupilumab or matching placebo) from week 0 to week 52 open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. follow-up period: 12 weeks the maximum duration of study per participant is up to 68 weeks.


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.