Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
RESOLUTE Trial Summary
This trial is testing a potential new drug for people with moderate to severe Ulcerative Colitis to see if it is more effective and safe than placebo.
Who is the study for?
Adults with active Ulcerative Colitis for at least 3 months, who haven't responded well to certain treatments like corticosteroids or biologics. They must not have Crohn's Disease, a history of significant infections including COVID-19 recently, or be on conflicting medications. Stable doses of some meds are required and women shouldn't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing SAR443122 against a placebo in people with moderate to severe Ulcerative Colitis over 52 weeks. It includes an initial treatment phase followed by maintenance or switch to the highest dose if no improvement is seen. The goal is to find the right dose based on safety and effectiveness.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to SAR443122 compared to those taking a placebo. Side effects could range from mild symptoms related to digestion and immune response to more serious complications.
RESOLUTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who achieve clinical remission at Week 12 by modified Mayo Score (mMS)
Secondary outcome measures
Inflammatory Bowel Diseases
Change from baseline in abdominal signs and symptoms assessed by UC-PRO/SS at Week 12
Ulcerative Colitis
+13 moreRESOLUTE Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR443122 level 3Experimental Treatment1 Intervention
Dose level 3
Group II: SAR443122 level 2Experimental Treatment1 Intervention
Dose level 2
Group III: SAR443122 level 1Experimental Treatment1 Intervention
Dose level 1
Group IV: PlaceboPlacebo Group1 Intervention
Matching Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443122
2020
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,798 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
441 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had corticosteroids or cytapheresis therapy in the last 2 weeks.My disease extends at least 15 cm from the anal verge.I am currently on dialysis.I need TPN due to intestinal failure or short bowel syndrome.I have been treated with a RIPK1 inhibitor before.I have been diagnosed with a type of colitis.I have Crohn's Disease.I do not have active TB or a history of untreated TB.I have tested positive for COVID-19, suspect I have it, or was exposed to it recently.I have severe intestinal disease or a very swollen colon.I have been treated with Tysabri before.I haven't had any serious infections in the last 6 months.I have not responded well or am intolerant to certain ulcerative colitis or Crohn's disease treatments.I have used rectal 5-aminosalicylate or corticosteroids in the last 4 weeks.I have an ileal pouch or an ostomy.I have had active Ulcerative Colitis for at least 3 months, confirmed by a recent endoscopy.I am taking more than 9 mg/day of budesonide.I have had or will have surgery to remove part of my colon.I haven't had a serious infection in the last 4 weeks.My diabetes is not under control, with an HbA1c level of 9.0% or higher.I haven't taken any advanced therapy drugs recently.I do not have untreated thyroid issues or unexplained high prolactin levels.I haven't taken cyclosporine, mycophenolate, sirolimus, thalidomide, or tacrolimus in the last 4 weeks.I have abnormal growths in my colon that are not adenomas.I have taken antibiotics for UC or a gut infection in the last 4 weeks.I have or had hepatitis B or C, but if I had hepatitis C, it's now cleared.I have not had any cancer recurrence or new cancer in the last 5 years.I haven't used any therapeutic enema or suppository, except for colonoscopy or sigmoidoscopy prep, in the last 4 weeks.I have not received a live vaccine in the last 3 months.I am taking more than 25 mg/day of prednisone or its equivalent.I haven't had a fever or serious infection needing treatment in the last 4 weeks.I haven't taken any antidiarrheal medication in the last 2 weeks.I have been on a stable dose of corticosteroids for at least 2 weeks.I haven't had COVID-19 or needed a ventilator due to COVID-19 in the last 3 months.I have been on methotrexate, azathioprine, or 6-mercaptopurine for at least 8 weeks with a stable dose for the last 4 weeks.I have been on a stable dose of oral 5-aminosalicylates, mesalamine, or sulfasalazine for at least 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: SAR443122 level 1
- Group 2: SAR443122 level 2
- Group 3: SAR443122 level 3
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must be met in order to qualify for participation in this trial?
"This medical trial seeks 182 people with ulcerative colitis aged between 18 and 75. Most importantly, participants must have clinical signs of active UC for at least 3 months prior to screening, an extent of 15cm from the anal verge, and be inadequate or non-responders,have shown loss of response or are intolerant to certain treatments such as amino-salicylates. Additionally all patients should adhere to local contraceptive regulations where applicable."
Answered by AI
Has SAR443122 achieved the necessary regulatory clearance for mass distribution?
"Based on the current evidence, SAR443122 scored a 2 for safety due to its Phase 2 status. Though there is some data supporting its security, no efficacy has been demonstrated yet."
Answered by AI
What is the capacity for participation in this clinical examination?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study remains actively recruiting patients after its initial posting date of November 4th 2022 and its most recent edit in November 2nd 2022. 182 individuals are sought from a single site location."
Answered by AI
Does this clinical investigation admit individuals older than forty?
"This clinical trial involves patients aged between 18 and 75. Additionally, there are 70 trials taking place for younger individuals and 347 studies being conducted with participants over the age of 65."
Answered by AI
Can participants join this experiment currently?
"Affirmative. According to clinicaltrials.gov, this clinical trial is actively seeking patients and was first posted on November 4th 2022 before being updated a fortnight later. 182 individuals are recruited from 1 medical centre for the purpose of this experiment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger