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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))

Primary Purpose

Colitis Ulcerative

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dupilumab
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis Ulcerative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • Om Research-Site Number:8400029Recruiting
  • Om Research-Site Number:8400028Recruiting
  • TLC Clinical Research Inc-Site Number:8400020Recruiting
  • Clinical Trials Management Service-Site Number:8400034Recruiting
  • Wellness Clinical Research (WCR)-Site Number:8400009Recruiting
  • Homestead Associates-Site Number:8400004Recruiting
  • Advanced Research Institute, Inc.-Site Number:8400026Recruiting
  • AdtreMed-Site Number:8400035Recruiting
  • GCP Clinical Research-Site Number:8400014Recruiting
  • Gastroenterology Consultants PC-Site Number:8400022Recruiting
  • Gastro Center of Maryland-Site Number:8400021Recruiting
  • DiGiovanna Institute for Medical Education and Research-Site Number:8400006Recruiting
  • Javara Research-Site Number:8400008Recruiting
  • Care Access Research, Lumberton-Site Number:8400018Recruiting
  • Care Access Research, Youngstown-Site Number:8400015Recruiting
  • Gastroenterology Associates, P.A.-Site Number:8400012Recruiting
  • Katy Integrative Gastroenterology-Site Number:8400027Recruiting
  • Medrasa Clinical Research-Site Number:8400039Recruiting
  • GI Alliance - Southlake-Site Number:8400013Recruiting
  • Tyler Research Institute-Site Number:8400031Recruiting
  • Gastro Health &amp; Nutrition-Site Number:8400019Recruiting
  • Washington Gastroenterology-Site Number:8400025Recruiting
  • Washington Gastroenterology-Site Number:8400030Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :0320001Recruiting
  • Investigational Site Number :1240006Recruiting
  • Investigational Site Number :1240003Recruiting
  • Investigational Site Number :1520001Recruiting
  • Investigational Site Number :1520005Recruiting
  • Investigational Site Number :1520003Recruiting
  • Investigational Site Number :1520002Recruiting
  • Investigational Site Number :3920006Recruiting
  • Investigational Site Number :3920008Recruiting
  • Investigational Site Number :3920007Recruiting
  • Investigational Site Number :3920010Recruiting
  • Investigational Site Number :3920004Recruiting
  • Investigational Site Number :3920011Recruiting
  • Investigational Site Number :3920005Recruiting
  • Investigational Site Number :3920009Recruiting
  • Investigational Site Number :3920002Recruiting
  • Investigational Site Number :3920001Recruiting
  • Investigational Site Number :4100004Recruiting
  • Investigational Site Number :4100002Recruiting
  • Investigational Site Number :4100003Recruiting
  • Investigational Site Number :4100005Recruiting
  • Investigational Site Number :4100006Recruiting
  • Investigational Site Number :7100005Recruiting
  • Investigational Site Number :7100002Recruiting
  • Investigational Site Number :7100008Recruiting
  • Investigational Site Number :7100003Recruiting
  • Investigational Site Number :7100004Recruiting
  • Investigational Site Number :1580002Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Placebo

Arm Description

Initial loading dose followed by regular administration for the duration of the treatment period.

Initial loading dose followed by regular administration for the duration of the treatment period.

Outcomes

Primary Outcome Measures

Proportion of participants who are in clinical remission at Week 24
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.

Secondary Outcome Measures

Proportion of participants achieving clinical response by modified Mayo score at Week 8, Week 24, and Week 52
Clinical response by modified Mayo score is defined as a decrease from baseline in the modified Mayo score of ≥2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥1 OR an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Proportion of participants who are in clinical remission by modified Mayo score at Week 8 and Week 52
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Proportion of participants in symptomatic remission over time
Symptomatic remission is defined as Mayo stool frequency score = 0, or Mayo stool frequency score = 1 with a ≥1-point decrease from baseline, and Mayo rectal bleeding score = 0.
Proportion of participants achieving histologic-endoscopic healing at Week 8, Week 24, and Week 52
Histologic-endoscopic healing is defined by Mayo endoscopic subscore of 0 or 1 and histological healing (Geboes score <2). Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity. The Geboes Index score is a six-grade classification system for inflammation: Grade 0 - structural change only; Grade 1 -chronic inflammation; Grade 2 - lamina propria neutrophils; Grade 3 - neutrophils in epithelium; Grade 4 - crypt destruction; and Grade 5 - erosions or ulcers.
Proportion of participants with a Mayo endoscopic subscore of 0 or 1 without friability at Week 8, Week 24, and Week 52
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Proportion of participants with a Mayo endoscopic subscore of 0 at Week 8, Week 24, and Week 52
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Change from baseline in the partial Mayo score at Week 8, Week 24, and Week 52
The partial Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Physician's global assessment (PGA) subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The partial Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52 among participants receiving OCS at baseline
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Change from baseline in abdominal pain assessed by Abdominal Pain Numerical Rating Scale (NRS) at Week 8, Week 24, and Week 52
Abdominal pain NRS is a single item patient report outcome (PRO) tool that patients will use to report intensity of their worst abdominal pain during a daily recall period with 0 being 'no pain' and 10 being the 'worst pain imaginable'.
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Concentration of dupilumab in serum over time.
Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab.
Change from baseline (Screening visit) in the normalized enrichment scores (NES) in type 2 inflammation transcriptome signature at Week 24 and Week 52.
NES is a summary score of the expression of a specified set of genes defining a molecular phenotype.

Full Information

First Posted
February 3, 2023
Last Updated
September 29, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05731128
Brief Title
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))
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 30, 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
June 26, 2024 (Anticipated)
Study Completion Date
April 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 4 weeks Treatment period: 52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis Ulcerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Initial loading dose followed by regular administration for the duration of the treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Initial loading dose followed by regular administration for the duration of the treatment period.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent
Intervention Description
injection solution subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
injection solution subcutaneous
Primary Outcome Measure Information:
Title
Proportion of participants who are in clinical remission at Week 24
Description
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants achieving clinical response by modified Mayo score at Week 8, Week 24, and Week 52
Description
Clinical response by modified Mayo score is defined as a decrease from baseline in the modified Mayo score of ≥2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥1 OR an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Week 8, Week 24 and Week 52
Title
Proportion of participants who are in clinical remission by modified Mayo score at Week 8 and Week 52
Description
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Week 8 and Week 52
Title
Proportion of participants in symptomatic remission over time
Description
Symptomatic remission is defined as Mayo stool frequency score = 0, or Mayo stool frequency score = 1 with a ≥1-point decrease from baseline, and Mayo rectal bleeding score = 0.
Time Frame
Baseline up to Week 52
Title
Proportion of participants achieving histologic-endoscopic healing at Week 8, Week 24, and Week 52
Description
Histologic-endoscopic healing is defined by Mayo endoscopic subscore of 0 or 1 and histological healing (Geboes score <2). Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity. The Geboes Index score is a six-grade classification system for inflammation: Grade 0 - structural change only; Grade 1 -chronic inflammation; Grade 2 - lamina propria neutrophils; Grade 3 - neutrophils in epithelium; Grade 4 - crypt destruction; and Grade 5 - erosions or ulcers.
Time Frame
Week 8, Week 24 and Week 52
Title
Proportion of participants with a Mayo endoscopic subscore of 0 or 1 without friability at Week 8, Week 24, and Week 52
Description
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Time Frame
Week 8, Week 24 and Week 52
Title
Proportion of participants with a Mayo endoscopic subscore of 0 at Week 8, Week 24, and Week 52
Description
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Time Frame
Week 8, Week 24 and Week 52
Title
Change from baseline in the partial Mayo score at Week 8, Week 24, and Week 52
Description
The partial Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Physician's global assessment (PGA) subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The partial Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Baseline to Week 8, Week 24 and Week 52
Title
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52
Description
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Baseline up to Week 52
Title
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52 among participants receiving OCS at baseline
Description
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Time Frame
Baseline up to Week 52
Title
Change from baseline in abdominal pain assessed by Abdominal Pain Numerical Rating Scale (NRS) at Week 8, Week 24, and Week 52
Description
Abdominal pain NRS is a single item patient report outcome (PRO) tool that patients will use to report intensity of their worst abdominal pain during a daily recall period with 0 being 'no pain' and 10 being the 'worst pain imaginable'.
Time Frame
Baseline to Week 8, Week 24 and Week 52
Title
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time Frame
Baseline up to Week 64
Title
Concentration of dupilumab in serum over time.
Time Frame
Baseline up to Week 52
Title
Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab.
Time Frame
Baseline up to Week 64
Title
Change from baseline (Screening visit) in the normalized enrichment scores (NES) in type 2 inflammation transcriptome signature at Week 24 and Week 52.
Description
NES is a summary score of the expression of a specified set of genes defining a molecular phenotype.
Time Frame
Baseline to Week 24 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Facility Information:
Facility Name
Om Research-Site Number:8400029
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Name
Om Research-Site Number:8400028
City
Camarillo
State/Province
California
ZIP/Postal Code
93012
Country
United States
Individual Site Status
Recruiting
Facility Name
TLC Clinical Research Inc-Site Number:8400020
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management Service-Site Number:8400034
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellness Clinical Research (WCR)-Site Number:8400009
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead Associates-Site Number:8400004
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute, Inc.-Site Number:8400026
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Name
AdtreMed-Site Number:8400035
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Clinical Research-Site Number:8400014
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Consultants PC-Site Number:8400022
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastro Center of Maryland-Site Number:8400021
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Name
DiGiovanna Institute for Medical Education and Research-Site Number:8400006
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758-1802
Country
United States
Individual Site Status
Recruiting
Facility Name
Javara Research-Site Number:8400008
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28287
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research, Lumberton-Site Number:8400018
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Research, Youngstown-Site Number:8400015
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Associates, P.A.-Site Number:8400012
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Katy Integrative Gastroenterology-Site Number:8400027
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Name
Medrasa Clinical Research-Site Number:8400039
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance - Southlake-Site Number:8400013
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Recruiting
Facility Name
Tyler Research Institute-Site Number:8400031
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastro Health &amp; Nutrition-Site Number:8400019
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington Gastroenterology-Site Number:8400025
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington Gastroenterology-Site Number:8400030
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000IIH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240006
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Montreal
ZIP/Postal Code
H3G1A4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Concepcion
State/Province
Biobío
ZIP/Postal Code
4070038
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7620157
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8330034
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
451-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
802-8561
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920011
City
Kamakura-shi
ZIP/Postal Code
247-0056
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920005
City
Kashiwa-shi
ZIP/Postal Code
277-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Saitama-shi
ZIP/Postal Code
336-0963
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Sapporo-shi
ZIP/Postal Code
004-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Sapporo-shi
ZIP/Postal Code
065-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100004
City
Daegu
State/Province
Daegu-gwangyeoksi
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100002
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100003
City
Busan
State/Province
Gwangyeoksi
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100005
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100006
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100005
City
Cape Town
ZIP/Postal Code
7441
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100002
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100008
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100003
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100004
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580002
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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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