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Monoclonal Antibodies
SAR441566 for Ulcerative Colitis (SPECIFI-UC Trial)
Greenville, NC
Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
Participants with active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9, with specific subscores and disease extent criteria met
Must not have
Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
Participants who have ever been exposed to specific medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Summary
This trial is testing a new drug called SAR441566 in adults with moderate-to-severe ulcerative colitis. The study will last about 59 weeks and will involve taking the drug for either
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Who is the study for?
This trial is for adults with moderate-to-severe ulcerative colitis. Participants must be able to complete a screening, follow a year-long treatment plan, and attend up to 20 clinic visits. Details on specific inclusion or exclusion criteria are not provided.Check my eligibility
What is being tested?
The study tests SAR441566's effectiveness in achieving clinical remission of ulcerative colitis compared to a placebo. It's double-blind and includes an induction period (12 weeks), maintenance period (40 weeks), followed by an open-label phase for eligible participants.See study design
What are the potential side effects?
Potential side effects of SAR441566 aren't specified here but may include typical drug reactions such as injection site irritation, gastrointestinal discomfort, immune system changes, or other medication-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My ulcerative colitis is active and severe, scoring 5 to 9 on the Mayo scale.
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I have previously been treated for urinary cancer as required.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active form of colitis.
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I have taken specific medications before.
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I have had or will have surgery to remove part of my colon.
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I do not have active TB or untreated latent TB.
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I have tested positive for Hepatitis B or C antibodies.
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I do not have any active, chronic, or recurrent infections.
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I am not pregnant, breastfeeding, nor planning to become pregnant soon.
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I recently needed medicine for an infection.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Secondary study objectives
Change from baseline in PRO2 from randomization to Week 12
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
Proportion of participants achieving HEMI at Week 12
+8 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR441566 dose regimen 3Experimental Treatment1 Intervention
Participants will receive SAR441566 dose regimen 3
Group II: SAR441566 dose regimen 2Experimental Treatment1 Intervention
Participants will receive SAR441566 dose regimen 2
Group III: SAR441566 dose regimen 1Experimental Treatment1 Intervention
Participants will receive SAR441566 dose regimen 1
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive SAR441566-matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR441566
2023
Completed Phase 2
~330
Find a Location
Closest Location:Carolina Digestive Diseases- Site Number : 8400013· Greenville, NC
Who is running the clinical trial?
SanofiLead Sponsor
2,242 Previous Clinical Trials
4,082,992 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
341 Patients Enrolled for Ulcerative Colitis