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New hope for Crohn's: experimental drug SAR442970 enters phase 2 trial

NCT ID NCT06958536

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing an experimental drug called SAR442970 in about 99 adults with moderate to severe Crohn's disease. Participants will receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug can improve the appearance of the gut lining during a scope exam after 16 weeks. The study lasts up to 168 weeks and includes a long-term extension where eligible participants can receive the drug openly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR442970 (an experimental drug given as a shot under the skin)
What this could lead to
If successful, this could point toward a new treatment option for people with moderate to severe Crohn's disease who haven't responded well to current therapies.
What could go wrong
This is an early phase 2 trial with only 99 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Oct 2029

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 to 75 years

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: * Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening * Confirmed diagnosis of moderate-to-severe CD * History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies * On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.) * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: * Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome * Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * Participants with following ongoing known complications of CD: * Any manifestation that might require bowel surgery while enrolled in the study * Participant with ostomy or ileoanal pouch * Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome * Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections * History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    66 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number 8400028

    RECRUITING

    Miami, Florida, 33134, United States

  • Investigational Site Number: 0360001

    RECRUITING

    Footscray, 3011, Australia

  • Investigational Site Number: 0360002

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Investigational Site Number: 0360004

    RECRUITING

    Kurralta Park, South Australia, 5037, Australia

  • Investigational Site Number: 0560001

    RECRUITING

    Leuven, B-3000, Belgium

  • Investigational Site Number: 1560001

    RECRUITING

    Guangzhou, 510655, China

  • Investigational Site Number: 1560006

    RECRUITING

    Hangzhou, 310009, China

  • Investigational Site Number: 1560007

    RECRUITING

    Shenyang, 110004, China

  • Investigational Site Number: 1560008

    RECRUITING

    Changsha, 410013, China

  • Investigational Site Number: 2030002

    RECRUITING

    Brno, JM, 61500, Czechia

  • Investigational Site Number: 2030003

    RECRUITING

    Hradec Králové, 50012, Czechia

  • Investigational Site Number: 2030005

    RECRUITING

    Slaný, 274 01, Czechia

  • Investigational Site Number: 2500001

    RECRUITING

    Montpellier, 34090, France

  • Investigational Site Number: 2500002

    RECRUITING

    Toulouse, 31059, France

  • Investigational Site Number: 2500003

    RECRUITING

    Nice, 6000, France

  • Investigational Site Number: 2760001

    RECRUITING

    Ulm, 89081, Germany

  • Investigational Site Number: 2760002

    RECRUITING

    Minden, Northwest, 32423, Germany

  • Investigational Site Number: 2760003

    RECRUITING

    Jena, 07747, Germany

  • Investigational Site Number: 2760004

    RECRUITING

    Kiel, 24105, Germany

  • Investigational Site Number: 3920001

    RECRUITING

    Morioka, 020-8505, Japan

  • Investigational Site Number: 3920002

    RECRUITING

    Nishinomiya, 663-8501, Japan

  • Investigational Site Number: 3920003

    RECRUITING

    Hamamatsu, 431-3192, Japan

  • Investigational Site Number: 3920004

    RECRUITING

    Bunkyō City, 113-8519, Japan

  • Investigational Site Number: 3920005

    RECRUITING

    Ōita, Oita Prefecture, 870-0033, Japan

  • Investigational Site Number: 3920006

    RECRUITING

    Hamamatsu, Shizuoka, 432-8061, Japan

  • Investigational Site Number: 3920007

    RECRUITING

    Kashiwa, Chiba, 277-0871, Japan

  • Investigational Site Number: 3920009

    RECRUITING

    Hirosaki, 036-8545, Japan

  • Investigational Site Number: 6160001

    RECRUITING

    Krakow, 31-501, Poland

  • Investigational Site Number: 6160002

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

  • Investigational Site Number: 6160003

    RECRUITING

    Warsaw, 01-783, Poland

  • Investigational Site Number: 6160004

    RECRUITING

    Wroclaw, 54-206, Poland

  • Investigational Site Number: 6160005

    RECRUITING

    Lublin, 20-582, Poland

  • Investigational Site Number: 6160006

    RECRUITING

    Sopot, 81-756, Poland

  • Investigational Site Number: 6160008

    RECRUITING

    Warsaw, 00-189, Poland

  • Investigational Site Number: 7100003

    RECRUITING

    Johannesburg, 1619, South Africa

  • Investigational Site Number: 7240001

    RECRUITING

    Madrid, 28046, Spain

  • Investigational Site Number: 7240002

    RECRUITING

    Madrid, 28003, Spain

  • Investigational Site Number: 7240003

    RECRUITING

    Seville, 41009, Spain

  • Investigational Site Number: 8260001

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Investigational Site Number: 8260002

    RECRUITING

    London, HA8 0AD, United Kingdom

  • Investigational Site Number: 8260004

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Investigational Site Number: 8260005

    RECRUITING

    London, E11 1NR, United Kingdom

  • Investigational Site Number: 8260007

    RECRUITING

    Bury, BL9 7TD, United Kingdom

  • Investigational Site Number: 8400001

    RECRUITING

    Lancaster, California, 93534, United States

  • Investigational Site Number: 8400002

    RECRUITING

    Fredericksburg, Texas, 78229, United States

  • Investigational Site Number: 8400003

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Investigational Site Number: 8400005

    RECRUITING

    Escondido, California, 92025, United States

  • Investigational Site Number: 8400006

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Investigational Site Number: 8400007

    RECRUITING

    Orlando, Florida, 32804, United States

  • Investigational Site Number: 8400008

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Investigational Site Number: 8400009

    RECRUITING

    Harrisburg, Pennsylvania, 17110, United States

  • Investigational Site Number: 8400011

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • Investigational Site Number: 8400012

    RECRUITING

    Miami, Florida, 33136, United States

  • Investigational Site Number: 8400013

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Investigational Site Number: 8400015

    RECRUITING

    Lighthouse PT, Florida, 33064, United States

  • Investigational Site Number: 8400016

    RECRUITING

    Ogden, Utah, 84405, United States

  • Investigational Site Number: 8400017

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Investigational Site Number: 8400019

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Investigational Site Number: 8400022

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number: 8400024

    RECRUITING

    Tucson, Arizona, 85724, United States

  • Investigational Site Number: 8400025

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Investigational Site Number: 8400027

    RECRUITING

    Richmond, Virginia, 23249, United States

  • Investigative Site: 1560002

    RECRUITING

    Shanghai, 200092, China

  • Investigative Site: 1560003

    RECRUITING

    Changsha, 410011, China

  • Investigative Site: 1560004

    RECRUITING

    Nanchang, 330006, China

  • Investigative Site: 1560005

    RECRUITING

    Changzhou, 213003, China

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