CTRI/2025/07/090585
Recruiting
Phase 2
A Phase 2, multinational, multicenter, randomized, doubleblind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe ulcerative colitis.
Sanofi Healthcare India Pvt Limited11 sites in 1 country204 target enrollmentStarted: July 15, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Sanofi Healthcare India Pvt Limited
- Enrollment
- 204
- Locations
- 11
- Primary Endpoint
- To assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe UC
Overview
Brief Summary
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 target population of the study is participants with moderate to severely active UC, defined as an active disease with a modified Mayo Score (mMS) from 5 to 9, with a modified Mayo Endoscopic Subscore (mMES) more than equal to 2, as confirmed by a central reader, an average daily very soft or liquid stool frequency (SF) more than equal to1, and average rectal bleeding (RB) subscore more than equal to 1 at screening. Participants on stable doses of standard therapies such as aminosalicylates (ASAs), oral steroids, thiopurines (azathioprine [AZA] or 6-mercaptopurine [6-MP]) or methotrexate (MTX) and not on medications prohibited due to the risk of drug-drug interaction (DDI) or known risk of Torsade de Pointes (TdP) would be eligible for the study. Participants who do not meet the inclusion criteria or meet one of the exclusion criteria will not be enrolled.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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 more than equal to 3 months before screening and confirmed by endoscopy during the screening period.
- •Active moderate-to-severe UC at screening as defined by a mMS of 5 to 9 (without the PGA, with a minimum RB subscore more than equal to 1, a minimum SF subscore more than equal to 1, a mMES more than equal to 2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent more than 15 cm from the anal verge.
- •Must have received prior treatment for UC (either a or b below or combination of both)- a-No prior exposure to AT, but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds- 5-ASA, 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 b-Inadequate response to, loss of response to or intolerance to treatment with more than equal to 1 approved
- •AT such as a biologic agent (such as TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or experimental biologic UC therapeutics), or a small molecule (such as a JAKi or S1PRm) for UC. The treatment must have been discontinued according to the following timeline- -anti-TNF, anti-IL12/23 and anti-IL23 therapies at least 8 weeks before randomization. -vedolizumab, ustekinumab or rizankizumab treatment at least 8 weeks before randomization. -experimental biologic UC therapy at least 8 weeks before randomization or 5 times the terminal half-life of the investigational drug, whichever is longer. -JAKi or S1PRm at least 2 weeks before randomization. -experimental biologic small molecule at least 2 weeks before randomization or 5 times the terminal half-life of the IMP, whichever is longer.
- •Participant may be receiving a therapeutic dosage of at least 1 of the following drugs- -Oral 5-ASA compounds- prescribed dose must be stable for at least 2 weeks before screening colonoscopy or stopped treatment at least 2 weeks prior to screening colonoscopy. -Oral corticosteroids must be at a prednisone-equivalent dose of 25 mg/day, or 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks prior to the screening colonoscopy or stopped at least 2 weeks prior to screening colonoscopy. -AZA, 6-MP, or MTX- if the prescribed dose has been stable for at least 4 weeks before screening endoscopy, or, if stopped, medication must have been discontinued or at least 4 weeks prior to screening endoscopy to be considered eligible for enrollment. Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a-Male participants Male participants who are sexually active with female partner(s) of childbearing potential must agree to practice the protocol-specified contraception during the study and for up to 3 months, after the last dose of study intervention which will allow for one complete cycle of spermatogenesis following study drug discontinuation. Males must refrain from donating sperm during the study treatment period and for up to 3 months after the last dose of study intervention. b-Female participants -A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies-.
- •Is a woman of nonchildbearing potential (WONCBP) OR.
- •Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), preferably with low user dependency, during the study intervention period (to be effective before starting the intervention) and for at least 3 months after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period. -A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at screening and a negative urine pregnancy test before the first administration of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. a-WOCBP may participate and include who are- infertile due to surgical sterilization b-(hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as c-Mullerian agenesis, or post-menopausal.
- •defined as either- d-A woman more than equal to 50 years of age with an intact uterus, not on hormone therapy, who has had e-either f--cessation of menses for at least 1 year, or g--at least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone h--(FSH) more than 40 mIU/mL, i--A woman more than equal to 55 years of age not on hormone therapy, who has had at least 6 months of j--spontaneous amenorrhea, or k--A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy. Informed Consent Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participants legally authorized representative.
Exclusion Criteria
- •Medical conditions
- •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 ostomy or ileoanal pouch
- •Participants with prior colectomy or anticipated colectomy during their participation in the study.
- •Participants with fecal sample positive for ova or parasites, or any aerobic pathogens at screening including: Aeromonas, Plesiomonas, Shigella, Salmonella, Yersinia, Campylobacter, or E. coli sp. or positive for Clostridium difficile B toxin in stools.
- •At the screening visits, participants with positive-.
- •Hepatitis B surface antigen (HBsAg), or Hepatitis B core antibody immunoglobulin M (HBcAb IgM) or HBcAb total, or Hepatitis C virus antibody (HCVAb) confirmed by positive HCV-RNA. (Participants with a positive HCVAb and negative HCV-RNA who have documented evidence of completing HCV anti-virals with cure may be included).
- •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 with active tuberculosis or who meet tuberculosis exclusionary parameters:.
Outcomes
Primary Outcomes
To assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe UC
Time Frame: 52 weeks
Secondary Outcomes
- To assess the effect of different doses of SAR441566 on clinical response in participants with moderate-to-severe UC(52 weeks)
Investigators
Study Sites (11)
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