Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aimed at gut inflammation shows promise in early trial

NCT ID NCT05731128

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether dupilumab can help people with moderate to severe ulcerative colitis that has a certain type of immune cell activity (eosinophilic phenotype). About 68 adults will receive either dupilumab or a placebo for 52 weeks. The main goal is to see if symptoms and gut inflammation improve by week 24.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colitis ulcerative are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

Contacts and locations

Locations

  • Advanced Gastroenterology Associates - Decatur- Site Number : 8400047

    Decatur, Texas, 76234, United States

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

    New Port Richey, Florida, 34653, United States

  • Care Access - Lumberton- Site Number : 8400018

    Lumberton, North Carolina, 28358, United States

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

    Thousand Oaks, California, 91360, United States

  • DiGiovanna Family Care- Site Number : 8400006

    Massapequa, New York, 11758, United States

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

    Orange Park, Florida, 32073, United States

  • Digestive Health Specialists of Tyler- Site Number : 8400031

    Tyler, Texas, 75701, United States

  • GCP Clinical Research- Site Number : 8400014

    Tampa, Florida, 33609, United States

  • GI Pros- Site Number : 8400046

    Naples, Florida, 34102, United States

  • Gastroenterology Consultants - Roswell- Site Number : 8400022

    Roswell, Georgia, 30076, United States

  • Homestead Associates in Research- Site Number : 8400004

    Homestead, Florida, 33033, United States

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1125, Argentina

  • Investigational Site Number : 0320004

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320006

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Investigational Site Number : 0320007

    Buenos Aires, 1028, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1119, Argentina

  • Investigational Site Number : 1240003

    Montreal, Quebec, H3G 1A4, Canada

  • Investigational Site Number : 1240006

    Montreal, Quebec, H1T 2M4, Canada

  • Investigational Site Number : 1240007

    Edmonton, Alberta, T5R 1W2, Canada

  • Investigational Site Number : 1240010

    Scarborough Village, Ontario, M1B 3V4, Canada

  • Investigational Site Number : 1520001

    Concepción, Biobio, 4070038, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8380456, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7620001, Chile

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 8360156, Chile

  • Investigational Site Number : 1580002

    Taichung, 404, Taiwan

  • Investigational Site Number : 3920001

    Sapporo, Hokkaido, 065-0033, Japan

  • Investigational Site Number : 3920002

    Sapporo, Hokkaido, 004-0041, Japan

  • Investigational Site Number : 3920004

    Bunkyo, Tokyo, 113-8510, Japan

  • Investigational Site Number : 3920005

    Kashiwa, Chiba, 277-0871, Japan

  • Investigational Site Number : 3920006

    Nagoya, Aichi-ken, 451-8511, Japan

  • Investigational Site Number : 3920007

    Kyoto, 605-0981, Japan

  • Investigational Site Number : 3920008

    Kitakyushu, Fukuoka, 802-0077, Japan

  • Investigational Site Number : 3920009

    Saitama, 336-0963, Japan

  • Investigational Site Number : 3920010

    Shimizu, Shizuoka, 411-0905, Japan

  • Investigational Site Number : 3920011

    Kamakura, Kanagawa, 247-0056, Japan

  • Investigational Site Number : 4100002

    Wŏnju, Gangwon-do, 26426, South Korea

  • Investigational Site Number : 4100003

    Haeundae-gu, Busan, 48108, South Korea

  • Investigational Site Number : 4100004

    Daegu, Gyeongsangbuk-do, 42415, South Korea

  • Investigational Site Number : 4100005

    Daegu, Daegu, 41944, South Korea

  • Investigational Site Number : 4100006

    Daejeon, Daejeon, 34943, South Korea

  • Investigational Site Number : 4840002

    Torreón, Coahuila, 27000, Mexico

  • Investigational Site Number : 4840003

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840004

    Mexico City, Mexico City, 01120, Mexico

  • Investigational Site Number : 4840005

    Saltillo, Coahuila, 25020, Mexico

  • Investigational Site Number : 4840007

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number : 7100001

    Johannesburg, 2193, South Africa

  • Investigational Site Number : 7100002

    Cape Town, 7708, South Africa

  • Investigational Site Number : 7100003

    Port Elizabeth, 6045, South Africa

  • Investigational Site Number : 7100004

    Pretoria, 0002, South Africa

  • Investigational Site Number : 7100005

    Cape Town, 7405, South Africa

  • Investigational Site Number : 7100006

    Johannesburg, 1821, South Africa

  • Investigational Site Number : 7100007

    Cape Town, 7800, South Africa

  • Investigational Site Number : 7100008

    Kempton Park, 1619, South Africa

  • Investigational Site Number : 7100009

    Cape Town, 7500, South Africa

  • Investigational Site Number : 7920001

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Gaziantep, 27310, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Istanbul, 34734, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Zonguldak, 67000, Turkey (Türkiye)

  • Katy Integrative Gastroenterology- Site Number : 8400027

    Katy, Texas, 77494, United States

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

    Sherman, Texas, 75092, United States

  • Om Research - Oxnard- Site Number : 8400028

    Oxnard, California, 93036, United States

  • Om Research- Site Number : 8400029

    Apple Valley, California, 92307, United States

  • Palmtree Clinical Research- Site Number : 8400048

    Palm Springs, California, 92262, 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

  • TLC Clinical Research- Site Number : 8400020

    Beverly Hills, California, 90211, United States

  • Tellabio International Research Services- Site Number : 8400041

    Pembroke Pines, Florida, 33025, United States

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

    Southlake, Texas, 76092, United States

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

    Charlotte, North Carolina, 28287, United States

  • UPMC Presbyterian- Site Number : 8400038

    Pittsburgh, Pennsylvania, 15213, United States

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

    San Juan, 00936, Puerto Rico

  • 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

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

    Miami Lakes, Florida, 33016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.