Health Condition 1: K509- Crohns disease, unspecified
Conditions
Interventions
Intervention1: SAR441566 100 mg
: For each dose arm, the participant will take 2 tablets in the morning and 2 in the evening (4 tablets total per day).
Arm 200 mg BID: 4 tablets of SAR441566 100 mg da
Sponsors
Sanofi Healthcare India Pvt Limited (SHIPL)
Eligibility
Inclusion criteria
Inclusion criteria: I 01. Male or female participants aged 18 to 75 years at the time of signing the ICF. Type of participant and disease characteristics I 02. Participants with confirmed diagnosis of CD for at least 3 months prior to screening. Appropriate documentation of endoscopy, radiology andor biopsy (histology) results consistent with the diagnosis of CD, as determined by the Investigator, must be available whenever possible. I 03. Participants with moderate to severely active CD, defined as- active disease with a CDAI score of 220 to 450, with endoscopic SES-CD score (excluding the presence of narrowing component) more than equal to 6 (or more than equal to 4 for participants with isolated ileal disease), as confirmed by a central reader AND average daily very soft or liquid SF more than equal to 4.0 and/or average daily AP score more than equal to 2.0 at screening. Prior Treatment I 04. Must have received prior treatment for CD (either a or b below or a combination of both a and b): a) history of no prior exposure to approved AT (AT being defined as any biologic, JAKi or S1PRm) but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: 6-MP, AZA, MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of CD) OR b) history of inadequate response to, loss of response to, or intolerance to, treatment with one or more approved AT(s) where AT is a biologic agent for CD (eg, TNF antagonists, anti-integrin, anti-IL-12/23, anti-IL-23, or experimental biologic CD therapeutics) ora small molecule (such as JAKi or S1PRm). The treatment must have been discontinued according to the following timeline: - Treatment with a TNF antagonist, vedolizumab, ustekinumab or rizankizumab at least 8 weeks before randomization. - Experimental CD therapy at least 8 weeks before randomization (for biologics) or 5 times the terminal half-lives of the investigational drug, whichever is longer. I 05. Participant may be receiving a therapeutic dosage 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 less than equal to 20 mg/day, or less than equal to 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 colonoscopy, or, if stopped, medication must have been discontinued for at least 4 weeks prior to screening colonoscopy to be considered eligible for enrollment. - Antibiotics (except those that may be QTc prolonging) prescribed at doses that have been stable for at least 4 weeks before screening colonoscopy, or if stopped, medication must have been discontinued at least 4 weeks prior to screening colonoscopy to be considered eligible for enrollment. Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding. I 06. 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
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA Participants are excluded from the study if any of the following criteria apply: Medical conditions E 01. Participants with active UC, indeterminate colitis or short bowel syndrome. E 02. Participants with CD isolated to the stomach, duodenum, jejunum, or peri-anal region, without colonic or ileal involvement. E 03. Participants with following ongoing known complications of CD -Fistulizing disease -Abscess (abdominal or peri anal) -Symptomatic bowel strictures -Two entire missing segments (either surgically removed or not visible during most recent colonoscopy) of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum -Fulminant colitis -Toxic megacolon -Or any other 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 more than 3 bowel resections E 04. Participant with a gastrointestinal infection, as indicated by a positive stool culture at screening for aerobic pathogens (including Aeromonas, Plesiomonas, Shigella, Salmonella, Yersinia, Campylobacter, or E. coli spp), a positive ova and parasite stool evaluation, or a positive Clostridium difficile B toxin in stools. E 05. At screening visit, participants with positive -Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody immunoglobulin M (HBcAb IgM), or HBc Ab total -Hepatitis C virus antibody (HCVAb) confirmed by positive by positive hepatitis C virus-deoxyribonucleic (HCV RNA) (participants with HCVAb and negative HCV RNA who have documented evidence of completing HCV anti-viral with cure may be included) -Any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex E 06. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening. E 07. Participants with active TB or who meet TB exclusionary parameters: -Active TB or a history of incompletely treated TB -Undergoing treatment of latent TB infection (LTBI) -Positive QuantiFERON -TB test at screening. Indeterminate QuantiFERON -TB may be repeated once during screening period and will be considered positive if retest results positive or indeterminate -Current household contacts with active TB -Received Bacillus Calmette-Gu rin vaccination within 12 months prior to screening -Participants meeting all the following TB-related criteria would not excluded: ---Documented completed appropriate LTBI treatment, or treated for active TB infection (with a treatment regimen as per local guidelines), - Have obtained consultation with specialist to rule out or treat active TB infection --- For whom review and approval from Sponsor have been granted are eligible Note: TB testing is mandatory to rule out active/latent TB and a blood sample for QuantiFERON Tuberculosis Gold Interferon ---Gamma Release Assay testing should be sent to the central laboratory. E 08. Participants presenting with acti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess efficacy and dose response of different doses of SAR441566 on endoscopic response at the end of induction treatment in participants with moderate to severe CDTimepoint: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the effect of different doses of SAR441566 on clinical remission at the end of induction treatment in participants with moderate to severe CD.Timepoint: week 12;- To assess the effect of different doses of SAR441566 on patient-reported outcomes (PRO)/signs and symptoms of CD at the end of induction treatment.Timepoint: week 12;-To assess the effect of different doses of SAR441566 on the composite endpoint of clinical remission and endoscopic response at the end of induction treatment in participants with moderate to severe CD.Timepoint: week 12;- To assess the effect of different doses of SAR441566 on endoscopic remission at the end of induction treatment in participants with moderate to severe CD.Timepoint: week 12;- To assess the effect of different doses of SAR441566 on clinical response at the end of induction treatment in participants with moderate to severe CD.Timepoint: week 12;- To assess the effect of different doses of SAR441566 on disease specific QOL at the end of induction treatment.Timepoint: week 12;- To assess PK of different doses of SAR441566 in participants with moderate to severe CDTimepoint: Week 12;- To assess the safety and tolerability of different doses of SAR441566 in participants with moderate to-severe CDTimepoint: week 12 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Georgia, Germany, Hungary, India, Italy, Japan, Mauritius, Netherlands, Poland, Republic of Korea, Romania, Serbia, Spain, Turkey, United States of America
Contacts
Public ContactMs Pranali Auti Clinical
Sanofi India Limited (SIL)
Outcome results
None listed