Testing SAR442970 compared to placebo in adults with moderate to severe Crohn’s disease

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What is this study about?

This study focuses on patients with moderate to severe Crohn’s disease, which is a chronic inflammatory condition affecting the digestive tract. The research evaluates a new medication called SAR442970, which is given as an injection under the skin. The study aims to determine how well different doses of this medication work in improving the condition of the intestinal lining in people with Crohn’s disease.

The study compares SAR442970 with placebo in patients who have not responded well enough to previous treatments. The medication or placebo will be administered through subcutaneous injections, which means the medicine is given under the skin. The maximum daily dose of the medication will be 150 milligrams, with a total maximum dose of 300 milligrams over the course of treatment.

The treatment period lasts for 52 weeks, during which patients will receive either the study medication or placebo. Throughout the study, doctors will monitor the condition of the intestinal lining and track various symptoms of Crohn’s disease. They will also check how safe the medication is and how well patients tolerate it. Participants will have regular check-ups to assess their response to treatment and monitor for any side effects.

1 Initial evaluation

You will undergo a screening process to confirm your eligibility for the study.

A colonoscopy will be performed to assess your Crohn’s disease activity.

Your disease activity will be measured using a scoring system called CDAI (Crohn’s Disease Activity Index).

2 Treatment initiation

You will be randomly assigned to receive either SAR442970 or placebo.

The medication will be given as an injection under the skin (subcutaneous injection).

This initial treatment period will last for 16 weeks.

3 First assessment period

At week 16, you will undergo another colonoscopy to evaluate your response to treatment.

Your disease activity will be measured again using the CDAI score.

Your quality of life will be assessed using specific questionnaires (IBDQ and FACIT-F).

4 Extended treatment

The treatment will continue until week 52.

Regular assessments of your condition will be performed during this period.

Blood samples will be taken to measure the medication levels in your body.

5 Final evaluation

At week 52, a final colonoscopy will be performed to assess your response to treatment.

Your disease activity and clinical response will be evaluated one last time.

The study will assess if you achieved both clinical improvement and healing of the intestinal lining.

Who Can Join the Study?

  • Age between 18 and 75 years old
  • Must have been diagnosed with Crohn’s disease for at least 3 months before screening, confirmed by tissue sample (biopsy), endoscopy, or imaging tests
  • Must have moderate to severe active disease with:
    – A specific disease activity score (CDAI) between 220 and 450
    – Evidence of disease activity on endoscopy
    – At least 4 very soft or liquid stools per day and/or daily abdominal pain
  • Must have previously received treatment with either:
    – Standard medications (such as 5-ASA, azathioprine, methotrexate, or corticosteroids) without adequate improvement, OR
    – Between 1 and 3 advanced therapies (such as biologics or small molecule drugs) without adequate improvement
  • If currently taking medications, doses must be stable for:
    – At least 2 weeks for 5-ASA compounds and corticosteroids
    – At least 4 weeks for azathioprine, 6-MP, methotrexate, or antibiotics
  • Must agree to use appropriate contraception:
    – Men must use condoms during the study and for 5 months after
    – Women must use highly effective contraception during the study and for 5 months after
    – Women must have a negative pregnancy test before starting
  • Must be willing to participate and follow study requirements
  • Must be able to provide written informed consent

Who Cannot Join the Study?

  • Current or history of intestinal strictures (narrowing of the intestine) or bowel surgery in the past 6 months
  • Active or history of severe infections, including tuberculosis, hepatitis B, or hepatitis C
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe allergic reactions or known hypersensitivity to study medications
  • Pregnant or breastfeeding women
  • Significant heart, liver, or kidney problems
  • Use of other biological treatments (specialized medications that affect the immune system) within the past 2-3 months
  • Active gastrointestinal infection or other serious infection requiring antibiotics
  • Major surgery planned during the study period
  • Participation in another clinical trial within the past 30 days
  • Current substance abuse or severe mental health conditions that could interfere with study participation
  • Live vaccines received within 4 weeks before starting the study
  • Conditions that could interfere with endoscopy procedure (examination of the intestine using a camera)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Futuremeds Sp. z o.o. Wroclaw Poland
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
PreventaMed s.r.o. Olomouc Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Eb Group Sp. z o.o. Warsaw Poland
Endoskopia Sp. z o.o. Sopot Poland
Planetmed Sp. z o.o. Wroclaw Poland
Nemocnice Slany Slany Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Medrise Sp. z o.o. Lublin Poland
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Gastroenterologische Gemeinschaftspraxis Minden Minden Germany
Vyedlgkn &goog Vulpalt Swy z otim Wroclaw Poland
Tfxqckzy Shz z oknv Piotrkow Trybunalski Poland
Czrnhaw Mapnbifx Lsyaoyj Jbwikr Łavo Chojnice Poland
Fzlqrvlsj Pspd Lw Ixlafutaulkqf Bsdeqihks Dhz Hevlcxsb Ubakhlrgvwmmc Lk Pxc Madrid Spain
Ipvdtsku dy Capovzqqredx Hdsoadjqnce Uitpjzekvlzqk du Svslz Eqruejy (avtgidw Saint Priest En Jarez France
Wta Wlrpkn Ipl Pplgy Pkamyntt Kffwfhv Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.10.2025
Czechia Czechia
Recruiting
01.10.2025
France France
Recruiting
01.10.2025
Germany Germany
Recruiting
01.10.2025
Poland Poland
Recruiting
01.10.2025
Spain Spain
Recruiting
01.10.2025

Trial locations

Investigated drugs:

SAR442970 is an investigational medication being studied for the treatment of Crohn’s disease. It is designed to help reduce inflammation in the digestive tract of people with moderate to severe Crohn’s disease. This medication is being tested to see if it can improve the appearance of the intestinal lining when viewed through an endoscope (a medical camera that examines the inside of the digestive tract).

Investigated diseases:

Crohn’s Disease – A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly occurs in the small intestine and colon. The inflammation can penetrate deep into the layers of the bowel wall, causing pain, diarrhea, fatigue, and weight loss. The disease typically develops in patches, with healthy sections in between affected areas. Crohn’s Disease can lead to complications such as narrowing of the intestines, formation of abnormal tunnels (fistulas), and nutritional deficiencies. The condition often follows a pattern of active periods (flares) alternating with periods of remission.

Trial ID:
2024-517016-30-00
Protocol code:
DRI18450
NCT ID:
NCT06958536
Trial Phase:
Therapeutic exploratory (Phase II)

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