ACTIVE_NOT_RECRUITING

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))

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype

Quick Facts

Study Start:2023-01-12

Study Completion:2027-02-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05731128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations

STUDY_DIRECTOR

Sanofi

Study Locations (Sites)

Om Research- Site Number : 8400029

Apple Valley, California, 92307

United States

TLC Clinical Research- Site Number : 8400020

Beverly Hills, California, 90211

United States

Om Research - Oxnard- Site Number : 8400028

Oxnard, California, 93036

United States

Palmtree Clinical Research- Site Number : 8400048

Palm Springs, California, 92262

United States

Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034

Thousand Oaks, California, 91360

United States

Homestead Associates in Research- Site Number : 8400004

Homestead, Florida, 33033

United States

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009

Miami Lakes, Florida, 33016

United States

GI Pros- Site Number : 8400046

Naples, Florida, 34102

United States

Advanced Research Institute - New Port Richey- Site Number : 8400026

New Port Richey, Florida, 34653

United States

Digestive Disease Consultants - Orange Park- Site Number : 8400042

Orange Park, Florida, 32073

United States

Tellabio International Research Services- Site Number : 8400041

Pembroke Pines, Florida, 33025

United States

GCP Clinical Research- Site Number : 8400014

Tampa, Florida, 33609

United States

Gastroenterology Consultants - Roswell- Site Number : 8400022

Roswell, Georgia, 30076

United States

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043

East Orange, New Jersey, 07018

United States

Smart Medical Research - New York- Site Number : 8400037

Jackson Heights, New York, 11372

United States

DiGiovanna Family Care- Site Number : 8400006

Massapequa, New York, 11758

United States

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008

Charlotte, North Carolina, 28287

United States

Care Access - Lumberton- Site Number : 8400018

Lumberton, North Carolina, 28358

United States

UPMC Presbyterian- Site Number : 8400038

Pittsburgh, Pennsylvania, 15213

United States

Advanced Gastroenterology Associates - Decatur- Site Number : 8400047

Decatur, Texas, 76234

United States

Katy Integrative Gastroenterology- Site Number : 8400027

Katy, Texas, 77494

United States

Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039

Sherman, Texas, 75092

United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400013

Southlake, Texas, 76092

United States

Digestive Health Specialists of Tyler- Site Number : 8400031

Tyler, Texas, 75701

United States

Victoria Gastroenterology- Site Number : 8400019

Victoria, Texas, 77904

United States

Washington Gastroenterology - Bellevue- Site Number : 8400025

Bellevue, Washington, 98004

United States

Washington Gastroenterology - Tacoma- Site Number : 8400030

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: Sanofi

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-12

Study Completion Date2027-02-19

Study Record Updates

Study Start Date2023-01-12

Study Completion Date2027-02-19

Terms related to this study

Additional Relevant MeSH Terms

Colitis Ulcerative