Dose-finding study of SAR443122 in adult participants with ulcerative colitis
- Conditions
- Colitis ulcerative
- Registration Number
- JPRN-jRCT2031230203
- Lead Sponsor
- Tanaka Tomoyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 182
Participants who have clinical evidence of active Ulcerative Colitis [UC] for >=3 months before screening as confirmed byendoscopy during the screening period and within no more than 10 days prior to randomization.
- Participants must have a minimum disease extent of 15 centimeters from the anal verge.
- Participants are inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of following approved treatments: amino-salicylate, corticosteroids, immunosuppressants or biologics other than natalizumab (Tysabri).
- Participants on corticosteroids must be on a stable dose >= 2 weeks prior to screening and during screening period.
- Participants on methotrexate, azathioprine or 6-mercaptopurine must be on treatment for at least 8 weeks prior to screening; and on a stable dose >=4 weeks prior to screening and during screening period.
- Participants on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for >=4 weeks prior to screening and during screening period.
- Participants on biologics must have been administered 1) at least 5 half-lives prior to randomization, or 2) participant must have an undetectable level of the biologic in their blood prior to randomization.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.
- Participants with Crohn's Disease (CD).
- Participants with diagnosis of indeterminate colitis.
- Participants with stool sample positive for culture for aerobic pathogens.
- Participants with prior colectomy or anticipated colectomy during their participation in the study.
- Participants with presence of ileal pouch or ostomy.
- Participants with fulminant disease or toxic megacolon.
- Participants with colonic dysplasia except for adenoma.
- Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition (TPN).
- Participants with history of recurrent or recent serious infection that has not resolved within 4 weeks prior to randomization.
- Participants presenting with malignancies except history of basal cell carcinoma or in-situ cervical carcinoma.
- Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study.
- Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study.
- Participants presenting with fever (>=38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections unacceptable per investigator's judgment.
- Participants who were administered any live (attenuated) vaccine within 3 months prior to the randomization Visit.
- Participants with a history of recurrent herpes zoster.
- Participants with uncontrolled diabetes, defined as HbA1c >=9.0% at the Screening Visit.
- Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated active or latent TB per local guidelines will be excluded from the study unless it is documented by a specialist that the participant has been adequately treated and can now start treatment with the receptor-interacting serine-threonine protein kinase 1 (RIPK1) kinase inhibitor.
- Participants presenting with opportunistic infections within six months prior to screening or while receiving anti-TNF treatment (TNF: tumor necrosis factor) in the last 6 months.
- Participants undergoing hemodialysis or peritoneal dialysis.
- Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at screening.
- Participants with Positive Hepatitis B surface antigen or positive Hepatitis B core antibody; and/or positive Hepatitis C antibody (HCV) at the Screening Visit. Participants that were treated for HCV and clear the virus documented by HCV RNA by polymerase chain reaction (PCR) below the limit of quantification can be eligible.
- Positive Coronavirus Disease 2019 (COVID-19) screening test suspected of COVID-19 infection or known exposure to COVID-19 during the screening period.
- History of COVID-19 infection within 4 weeks prior to Screening; history of mechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19 infection within 3 months prior to Screening or with residual significant complications from COVID-19 making it unsafe for the participant to enter this study.
- Participants presenting alcohol or drug dependency within the 2 years prior to the Screening Visit.
- Participants with unexplained, uncontrolled, or untreated thyroid dis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of participants who achieve clinical remission at Week 12 by modified Mayo Score (mMS)<br>[Time Frame: At Week 12]<br>The Mayo score (full MS) is a composite instrument that consists of patient reported stool frequency and rectal bleeding, endoscopy-derived measures and physician-reported assessment (PGA). The mMS is calculated omitting PGA. And an endoscopy score of 1 with no friability.
- Secondary Outcome Measures
Name Time Method