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Looking for participantsPhase2

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Sponsor: Sanofi

NCT ID: NCT06958536

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SAR442970 (drug), Placebo (drug)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
SAR442970 — drug: Route of Administration: Subcutaneous · Placebo — drug: Route of Administration: Subcutaneous
Patient visit burden
Not specified by the sponsor

In plain English

This study is looking at whether a medicine called SAR442970 is safe and works well for people with Crohn's disease (a long-term condition that causes inflammation in the gut). It is for people whose Crohn's disease is moderate to severe and who have already tried other treatments that did not work well enough or caused problems. The study is run by Sanofi.

Who can take part

  • Diagnosed with Crohn's disease at least 3 months before screening
  • Crohn's disease is confirmed as moderate to severe
  • Have tried standard treatments (such as 5-aminosalicylates, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but these did not work well, stopped working, or caused bad side effects
  • Are on stable doses of standard treatments before screening
  • Men and women must use contraception in line with local rules for people taking part in clinical studies

Who may not be able to

  • Active ulcerative colitis (a different type of gut inflammation), indeterminate colitis, unremoved adenomatous colonic polyps, colon cell changes called dysplasia, or short bowel syndrome
  • Crohn's disease only in the stomach, duodenum, jejunum, or around the anus, with no involvement of the colon or ileum
  • Ongoing Crohn's disease problems, such as anything that might need bowel surgery during the study
  • Having an ostomy or an ileoanal pouch
  • Conditions that could affect how the body absorbs the medicine, including short bowel syndrome
  • Bowel surgery to remove part of the bowel in the past 3 months, or more than 3 such surgeries in the past
  • Any other condition that, in the researcher's view, would make taking part unsafe

What taking part involves

  • • Taking the study medicine SAR442970 — details of how it is given are not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
99
Started
2025-06-03
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn's disease
  • • Phase2 - 99 participants
  • • This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with crohn's disease

Where?

  • • Bury - Investigational Site Number: 8260007
  • • Cambridge - Investigational Site Number: 8260004
  • • London - Investigational Site Number: 8260005
  • • London - Investigational Site Number: 8260002
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

Crohn's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
  • ✓Confirmed diagnosis of moderate-to-severe CD
  • ✓On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine...
  • ✓Contraceptive use by men and women should be consistent with local regulations regarding the methods of...

Who cannot take part

  • ✗Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised,...
  • ✗Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal...
  • ✗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
See the full criteria
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.

Where Is This Study? (5 UK sites)

Investigational Site Number: 8260007

Bury BL9 7TD, United Kingdom

Recruiting

Investigational Site Number: 8260004

Cambridge CB2 0QQ, United Kingdom

Recruiting

Investigational Site Number: 8260005

London E11 1NR, United Kingdom

Recruiting

Investigational Site Number: 8260002

London HA8 0AD, United Kingdom

Recruiting

Investigational Site Number: 8260001

London SE1 7EH, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03