A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease
Recruiting
Phase 2Interventional Study
Crohn's Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
99 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for people with moderate to severe Crohn's disease who have not responded well to previous treatments. Participants will take different doses of the study drug or a placebo over a period of up to 158 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Crohn's disease for at least 3 months.
I have moderate to severe Crohn's disease.
I have tried standard treatments but didn’t respond well to them.
I am on stable doses of standard treatments.
I will use contraception as required.
You may not be able to join if
I have active ulcerative colitis or other serious bowel issues.
I have Crohn's disease only in certain areas like the stomach or perianal region.
I need bowel surgery while in the study.
I have had bowel surgery in the last 3 months.
I have 3 or more bowel resections in my history.
I have a condition that could affect drug absorption.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a phase 2, 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 exten…
This is a phase 2, 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.
Trial Locations
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Eligibility 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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of the…
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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids 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, AZA, 6-MP, or 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.
Contacts
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