Digestive System
Conditions
Interventions
Placebo
Sponsors
Sanofi Aventis Recherche and Developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age I 01. Male or female participants aged 18 to 75 years, inclusive, 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 biopsy (histology), endoscopy and/or radiology results consistent with the diagnosis of CD, as determined by the Investigator, must be available. I 03. Participants with moderate to severely active CD, defined as: a) Persistently active disease with a CDAI score of 220 to 450, with endoscopic SES-CD score (excluding the presence of narrowing component) =6 (or =4 for participants with isolated ileal disease), as confirmed by a central reader, AND b) Average daily very soft or liquid SF =4.0 and/or average daily abdominal pain score =2.0 at screening. Prior treatment I 04. Must have received prior treatment for CD (either "a" or "b" below or combination of both): a) history of no prior exposure to ATs, but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: 5-ASAs, 6-MP, AZA, MTX, oral or 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 =1 approved AT such as a biologic agent for CD (eg, anti-TNFs, anti-integrin except to natalizumab [Tysabri®] or oral carotegrast methyl [Carogra®], anti-IL-12/23, antiIL- 23, or experimental biologic CD therapeutics) or a small molecule (such as JAKi or S1PRm). The treatment must have been discontinued according to the following timeline: - Anti-TNF therapy at least 8 weeks before randomization. - Vedolizumab, ustekinumab, or risankizumab treatment at least 8 weeks before randomization. - Experimental biologic CD therapy at least 8 weeks before randomization or 5 times the terminal half-life of the IMP.
Exclusion criteria
Exclusion criteria: Medical conditions E01. Participants with active UC, indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome. E02. Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement. E03. 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 >3 bowel resections. E04. Participant with fecal sample positive for culture for aerobic pathogens at screening including Aeromonas, Plesiomonas, Shigella, Salmonella, Yersinia, Campylobacter, or E. coli spp. or positive for Clostridium difficile B toxin in stools. E05. At screening visit, participants with positive: - Hepatitis B surface antigen (HBsAg) or HBcAb IgM, confirmed by positive hepatitis B virus (HBV) DNA or HBcAb total. - HCVAb confirmed by positive HCV (participants with HCVAb and negative HCV RNA may be included). - HIV-1 or HIV-2 positive antibody test. - Any other active, chronic, or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex. E06. History of recurrent or recent serious infection (eg, pneumonia, septicemia) within 4 weeks of screening. E07. History/suspected current immunosupression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of different doses of SAR442970 on endoscopic response at the end of the induction period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of different doses of SAR442970 on clinical remission at the end of induction period.;To assess the effect of different doses of SAR442970 on PRO/signs and symptoms of CD at the end of induction period.;To assess the effect of different doses of SAR442970 on endoscopic remission at the end of induction period.;To assess the effect of different doses of SAR442970 on the composite endpoint of clinical remission and endoscopic response at the end of induction period.;To assess the effect of different doses of SAR442970 on clinical response at the end of induction period.;To assess the effect of different doses of SAR442970 on disease specific QoL at the end of induction period.;To assess PK of different doses of SAR442970 in participants with CD.;To assess the safety and tolerability of different doses of SAR442970.;To evaluate the potential for immunogenicity of SAR442970 in all participants.;To assess the effect of different doses of SAR442970 on endoscopic remission at the end of the maintenance treatment.;To assess the effect of different doses of SAR442970 on clinical remission at the end of the maintenance treatment.;To assess the effect of different doses of SAR442970 on endoscopic response at the end of maintenance treatment.;To assess the effect of different doses of SAR442970 on clinical response at the end of maintenance treatment.;To assess the effect of different doses of SAR442970 on clinical remission and endoscopic response at the end of maintenance. | — |
Countries
South Africa
Contacts
Public ContactSuzaan Sirrals
Snr ClinOps Manager
Outcome results
None listed