A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Recruiting · NCT06867094 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
SAR441566SAR441566 matching Placebo
What this trial is about
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
- Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
- Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \>15 cm from the anal verge
- Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):
- History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
- History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC
- 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 are excluded from the study if any of the following criteria apply:
- Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
- Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
- Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
- Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
- Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
- Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
- Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
- Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
- Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
- History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
- If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
- Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
- Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
- Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
- Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
- Participants who received fecal microbial transplantation within 30 days prior to screening
- Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
- Participants who received IV corticosteroids within 14 days prior to screening or during screening period
- Screening laboratory and other analyses show abnormal results.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where it is running
60 locations listed across 11 US states.
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003 - Sun City, Arizona, United States
- Bristol Hospital- Site Number : 8400017 - Bristol, Connecticut, United States
- Novum Research- Site Number : 8400018 - Clermont, Florida, United States
- Clinical Research of Osceola- Site Number : 8400012 - Kissimmee, Florida, United States
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002 - Miami Lakes, Florida, United States
- GCP Clinical Research- Site Number : 8400016 - Tampa, Florida, United States
- GI Alliance - Glenview- Site Number : 8400005 - Glenview, Illinois, United States
- Illinois Gastroenterology Group- Site Number : 8400004 - Gurnee, Illinois, United States
- University of Michigan Health System - Ann Arbor- Site Number : 8400010 - Ann Arbor, Michigan, United States
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001 - New York, New York, United States
- Queens Village Primary Medical Center- Site Number : 8400011 - Queens Village, New York, United States
- NexGen Research- Site Number : 8400020 - Lima, Ohio, United States
- Frontier Clinical Research - Uniontown- Site Number : 8400006 - Uniontown, Pennsylvania, United States
- Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008 - Charleston, South Carolina, United States
- Gastro Health & Nutrition- Site Number : 8400007 - Katy, Texas, United States
- SI Research Associates- Site Number : 8400019 - Lubbock, Texas, United States
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400015 - Southlake, Texas, United States
- University of Washington Medical Center- Site Number : 8400014 - Seattle, Washington, United States
- Washington Gastroenterology - Tacoma- Site Number : 8400009 - Tacoma, Washington, United States
- Investigational Site Number : 3800007 - Alessandria, Italy
- Investigational Site Number : 3000001 - Athens, Greece
- Investigational Site Number : 3000003 - Athens, Greece
- Investigational Site Number : 2760005 - Berlin, Germany
- Investigational Site Number : 2760008 - Berlin, Germany
- Investigational Site Number : 3480001 - Budapest, Hungary
- Investigational Site Number : 0320003 - Buenos Aires, Argentina
- Investigational Site Number : 0320002 - Buenos Aires, Argentina
- Investigational Site Number : 0320001 - Buenos Aires, Argentina
- Investigational Site Number : 0320005 - Buenos Aires, Argentina
- Investigational Site Number : 1000001 - Burgas, Bulgaria
- Investigational Site Number : 7100002 - Cape Town, South Africa
- Investigational Site Number : 7100001 - Cape Town, South Africa
- Investigational Site Number : 2760010 - Duisburg, Germany
- Investigational Site Number : 2760009 - Frankfurt, Germany
- Investigational Site Number : 0560002 - Ghent, Belgium
- Investigational Site Number : 0400003 - Graz, Austria
- Investigational Site Number : 1560002 - Guangzhou, China
- Investigational Site Number : 1560001 - Hangzhou, China
- Investigational Site Number : 2760003 - Hanover, Germany
- Investigational Site Number : 3000002 - Heraklion, Greece
- Investigational Site Number : 3920012 - Hiroshima, Japan
- Investigational Site Number : 1560003 - Huizhou, China
- Investigational Site Number : 1560017 - Huizhou, China
- Investigational Site Number : 3560005 - Hyderabad, India
- Investigational Site Number : 7920002 - Istanbul, Turkey (Türkiye)
- Investigational Site Number : 7920003 - Izmir, Turkey (Türkiye)
- Investigational Site Number : 3560003 - Jaipur, India
- Investigational Site Number : 3560009 - Jaipur, India
- Investigational Site Number : 1560004 - Jiazhuang, China
- Investigational Site Number : 3920016 - Kagoshima, Japan
- Investigational Site Number : 3560002 - Kolkata, India
- Investigational Site Number : 7100004 - KwaDukuza, South Africa
- Investigational Site Number : 0560001 - Leuven, Belgium
- Investigational Site Number : 1560014 - Linhai, China
- Investigational Site Number : 3560004 - Ludhiana, India
- Investigational Site Number : 1560008 - Luoyang, China
- Investigational Site Number : 7920001 - Mersin, Turkey (Türkiye)
- Investigational Site Number : 2500003 - Nice, France
- Investigational Site Number : 3920001 - Niigata, Japan
- Investigational Site Number : 2030001 - Olomouc, Czechia
Showing 60 of 115 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →