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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (5 UK sites)
Investigational Site Number: 8260007
Bury BL9 7TD, United Kingdom
Investigational Site Number: 8260004
Cambridge CB2 0QQ, United Kingdom
Investigational Site Number: 8260005
London E11 1NR, United Kingdom
Investigational Site Number: 8260002
London HA8 0AD, United Kingdom
Investigational Site Number: 8260001
London SE1 7EH, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
