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Colitis UlcerativePhase 2NCT05731128

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))

A Phase 2 study testing Dupilumab in people with Colitis Ulcerative, run by Sanofi at 77 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis Ulcerative
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
77 sitesin 11 countries
Study dates
12 Jan 2023to 22 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

77 sites in 11 countries.

77 sites in 11 countries

United States27 sites

  • Om Research- Site Number : 8400029

    Apple Valley, California, 92307

  • Washington Gastroenterology - Bellevue- Site Number : 8400025

    Bellevue, Washington, 98004

  • TLC Clinical Research- Site Number : 8400020

    Beverly Hills, California, 90211

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

    Charlotte, North Carolina, 28287

  • Advanced Gastroenterology Associates - Decatur- Site Number : 8400047

    Decatur, Texas, 76234

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043

    East Orange, New Jersey, 07018

  • Homestead Associates in Research- Site Number : 8400004

    Homestead, Florida, 33033

  • Smart Medical Research - New York- Site Number : 8400037

    Jackson Heights, New York, 11372

  • Katy Integrative Gastroenterology- Site Number : 8400027

    Katy, Texas, 77494

  • Care Access - Lumberton- Site Number : 8400018

    Lumberton, North Carolina, 28358

  • DiGiovanna Family Care- Site Number : 8400006

    Massapequa, New York, 11758

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

    Miami Lakes, Florida, 33016

  • GI Pros- Site Number : 8400046

    Naples, Florida, 34102

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

    New Port Richey, Florida, 34653

  • Digestive Disease Consultants - Orange Park- Site Number : 8400042

    Orange Park, Florida, 32073

  • Om Research - Oxnard- Site Number : 8400028

    Oxnard, California, 93036

  • Palmtree Clinical Research- Site Number : 8400048

    Palm Springs, California, 92262

  • Tellabio International Research Services- Site Number : 8400041

    Pembroke Pines, Florida, 33025

  • UPMC Presbyterian- Site Number : 8400038

    Pittsburgh, Pennsylvania, 15213

  • Gastroenterology Consultants - Roswell- Site Number : 8400022

    Roswell, Georgia, 30076

  • Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039

    Sherman, Texas, 75092

  • Texas Digestive Disease Consultants - Southlake- Site Number : 8400013

    Southlake, Texas, 76092

  • Washington Gastroenterology - Tacoma- Site Number : 8400030

    Tacoma, Washington, 98405

  • GCP Clinical Research- Site Number : 8400014

    Tampa, Florida, 33609

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

    Thousand Oaks, California, 91360

  • Digestive Health Specialists of Tyler- Site Number : 8400031

    Tyler, Texas, 75701

  • Victoria Gastroenterology- Site Number : 8400019

    Victoria, Texas, 77904

Other trials in United States

Japan10 sites

  • Investigational Site Number : 3920004

    Bunkyo, Tokyo, 113-8510

  • Investigational Site Number : 3920011

    Kamakura, Kanagawa, 247-0056

  • Investigational Site Number : 3920005

    Kashiwa, Chiba, 277-0871

  • Investigational Site Number : 3920008

    Kitakyushu, Fukuoka, 802-0077

  • Investigational Site Number : 3920007

    Kyoto, 605-0981

  • Investigational Site Number : 3920006

    Nagoya, Aichi-ken, 451-8511

  • Investigational Site Number : 3920009

    Saitama, 336-0963

  • Investigational Site Number : 3920002

    Sapporo, Hokkaido, 004-0041

  • Investigational Site Number : 3920001

    Sapporo, Hokkaido, 065-0033

  • Investigational Site Number : 3920010

    Shimizu, Shizuoka, 411-0905

Other trials in Japan

South Africa9 sites

  • Investigational Site Number : 7100005

    Cape Town, 7405

  • Investigational Site Number : 7100009

    Cape Town, 7500

  • Investigational Site Number : 7100002

    Cape Town, 7708

  • Investigational Site Number : 7100007

    Cape Town, 7800

  • Investigational Site Number : 7100006

    Johannesburg, 1821

  • Investigational Site Number : 7100001

    Johannesburg, 2193

  • Investigational Site Number : 7100008

    Kempton Park, 1619

  • Investigational Site Number : 7100003

    Port Elizabeth, 6045

  • Investigational Site Number : 7100004

    Pretoria, 0002

Other trials in South Africa

Argentina6 sites

  • Investigational Site Number : 0320007

    Buenos Aires, 1028

  • Investigational Site Number : 0320008

    Buenos Aires, 1119

  • Investigational Site Number : 0320002

    Buenos Aires, 1125

  • Investigational Site Number : 0320006

    Mar del Plata, Buenos Aires, 7600

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigational Site Number : 0320004

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Chile5 sites

  • Investigational Site Number : 1520001

    Concepción, Biobio, 4070038

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7620001

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 8360156

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8380456

Other trials in Chile

Mexico5 sites

  • Investigational Site Number : 4840003

    Chihuahua City, 31000

  • Investigational Site Number : 4840007

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840004

    Mexico City, Mexico City, 01120

  • Investigational Site Number : 4840005

    Saltillo, Coahuila, 25020

  • Investigational Site Number : 4840002

    Torreón, Coahuila, 27000

Other trials in Mexico

South Korea5 sites

  • Investigational Site Number : 4100005

    Daegu, Daegu, 41944

  • Investigational Site Number : 4100004

    Daegu, Gyeongsangbuk-do, 42415

  • Investigational Site Number : 4100006

    Daejeon, Daejeon, 34943

  • Investigational Site Number : 4100003

    Haeundae-gu, Busan, 48108

  • Investigational Site Number : 4100002

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Canada4 sites

  • Investigational Site Number : 1240007

    Edmonton, Alberta, T5R 1W2

  • Investigational Site Number : 1240006

    Montreal, Quebec, H1T 2M4

  • Investigational Site Number : 1240003

    Montreal, Quebec, H3G 1A4

  • Investigational Site Number : 1240010

    Scarborough Village, Ontario, M1B 3V4

Other trials in Canada

Turkey (Türkiye)4 sites

  • Investigational Site Number : 7920003

    Gaziantep, 27310

  • Investigational Site Number : 7920005

    Istanbul, 34734

  • Investigational Site Number : 7920001

    Mersin, 33070

  • Investigational Site Number : 7920006

    Zonguldak, 67000

Other trials in Turkey (Türkiye)

Puerto Rico1 site

  • University of Puerto Rico - Medical Sciences Campus- Site Number : 6300002

    San Juan, 00936

Other trials in Puerto Rico

Taiwan1 site

  • Investigational Site Number : 1580002

    Taichung, 404

Other trials in Taiwan

About this study

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

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.

Being tested
Dupilumab, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent

    injection solution subcutaneous

  • PlaceboDrug

    injection solution subcutaneous

Study groups in NCT05731128
Study groupRoleWhat they receive
DupilumabExperimentalInitial loading dose followed by regular administration for the duration of the treatment period.
Receives: Drug: Dupilumab
PlaceboPlacebo comparatorInitial loading dose followed by regular administration for the duration of the treatment period.
Receives: Drug: Placebo
Open-label arm (optional)OtherRegular administration of open label dupilumab
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving clinical response at Week 24

    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.

    Measured: Week 24

Secondary outcomes (14)

  1. Proportion of participants who are in clinical response at 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.

    Measured: Week 52

  2. Proportion of participants who are in clinical remission at Week 24 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.

    Measured: Week 24 and Week 52

  3. 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.

    Measured: Baseline up to Week 52

  4. Proportion of participants achieving histologic-endoscopic healing at 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.

    Measured: Week 24 and Week 52

  5. Proportion of participants with a Mayo endoscopic subscore of 0 or 1 without friability at Week 24, and Week 52

    The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.

    Measured: Week 24 and Week 52

  6. Proportion of participants with a Mayo endoscopic subscore of 0 at Week 24, and Week 52

    The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.

    Measured: Week 24 and Week 52

  7. 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.

    Measured: Baseline to Week 8, Week 24 and Week 52

  8. 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.

    Measured: Baseline up to Week 52

  9. 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.

    Measured: Baseline up to Week 52

  10. 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'.

    Measured: Baseline to Week 8, Week 24 and Week 52

  11. Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)

    Measured: Baseline up to Week 64

  12. Concentration of dupilumab in serum over time.

    Measured: Baseline up to Week 64

  13. Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab.

    Measured: Baseline up to Week 64

  14. 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.

    Measured: Baseline to Week 24 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start12 Jan 2023
  3. Primary completion13 May 2026
  4. Study completion22 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731128
Sponsor's protocol ID
ACT17746
Other IDs
U1111-1278-4042
Status last verified
Jun 2026
First submitted
3 Feb 2023
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dupilumab in people with Colitis Ulcerative, run by Sanofi at 77 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Japan, South Africa, Argentina, Chile and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving clinical response at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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