Ulcerative Colitis
Conditions
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
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 had clinical evidence of active ulcerative colitis (UC) for >=3 months before screening and confirmed by endoscopy during the screening period. - Must have 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, modified Mayo Endoscopic Subscore [mMES] >=2 confirmed by central reader, a minimum sum of all subscores of 5), and a minimum disease extent of 15 cm from the anal verge. - Must have received prior treatment for UC (either "a" or "b" below or combination of both): a. History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC. b. History of inadequate response to, loss of response to or intolerance to treatment with >=1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat 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
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis. - Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools. - Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study. - Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma. - Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition. - History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis regimen. - Known history of or suspected significant current immunosuppression. - History or solid organ transplant or splenectomy. - History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident. - History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease. - Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin. - Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.). - History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening. - History of Interstitial Lung Disease. - Participants with any of the following results at Screening: - - Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or, - - Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or, - - Positive Hepatitis C Virus (HCV) antibody. - Screening laboratory and other analyses showing abnormal results. - History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants who achieve clinical remission at the end of Week 16 by mMS [Time frame: At Week 16] Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants who achieve endoscopic improvement at Week 16 [Time frame: At Week 16] Endoscopic improvement is defined as a mMES of 0 or 1 (where 1 does not include friability). The mMES ranges from 0 to 3 with higher scores indicating greater disease severity. 2. Proportion of participants who achieve endoscopic improvement at Week 52 [Time frame: At Week 52] Refer to the secondary outcome-1 for "endoscopic improvement". 3. Proportion of participants who achieve endoscopic response at Week 16 [Time frame: At Week 16] Endoscopic response is defined as an mMES decrease of at least 1. 4. Proportion of participants who achieve endoscopic response at Week 52 [Time frame: At Week 52] Refer to the secondary outcome-3 for "endoscopic response". 5. Proportion of participants who achieve endoscopic remission at Week 16 [Time frame: At Week 16] Endoscopic remission is defined as an mMES of 0. 6. Proportion of participants who achieve endoscopic remission at Week 52 [Time frame: At Week 52] Refer to the secondary outcome-5 for "endoscopic remission". 7. Proportion of participants who achieve clinical remission by total Mayo Score (MS) at Week 16 [Time frame: At Week 16] Clinical remission is defined as total MS 1. The total MS is a composite index designed to measure UC disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, PGA, and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity. 8. Proportion of participants who achieve clinical remission by total MS at Week 52 [Time frame: At Week 52] Refer to the secondary outcome-7 for "clinical remission by total MS". 9. Proportion of participants who achieve clinical response by total MS at Week 16 [Time frame: At Week 16] Clinical response by total MS is defined as a decrease from baseline in the total MS of >=3 points and at least 30% reduction from baseline, and a decrease | — |
Countries
Japan, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed