Crohn's Disease
Conditions
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening. - Confirmed diagnosis of moderate-to-severe CD. - History of prior exposure to standard treatment (5-Amino Salicylates [5-ASAs], steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss of response to or intolerance to at least one of these therapies. - On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine [AZA], 6-Mercaptopurine [6-MP], Methotrexate [MTX], or Antibiotics, etc.). - 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 with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome. - Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement. - Participants with following ongoing known complications of CD: - - Any 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. - History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who achieve endoscopic response at Week 16 [Time Frame: From Baseline to Week 16] Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16 [Time Frame: At Week 16] CDAI clinical remission is defined as CDAI score 1 in any individual variable based on central reading. 4. Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES-CD at Week 16 [Time Frame: At Week 16] CDAI clinical remission is defined as CDAI score 50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. 5. Percentage of participants who achieve CDAI clinical response at Week 16 [Time Frame: At Week 16] CDAI clinical response is defined as reduction of CDAI >=100 points from baseline. 6. Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score [Time Frame: From Baseline to Week 16] The IBDQ is a 32-item instrument assessing health-related quality of life in inflammatory bowel disease (IBD) patients across four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Each question evaluates experiences over the previous two weeks on a 7-point Likert scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224, with higher scores indicating better quality of life. Both domain-specific and overall scores can be calculated. 7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score [Time Frame: From Baseline to Week 16] The FACIT-F questionnaire assesses fatigue associated with anemia through 13 fatigue-related questions. Each item is scored on a 5-point Likert scale (0="not at all" to 4="very much"), with total scores ranging from 0 to 52. High scores represent less fatigue. For CD patients, a 7-10 point improvement on the FACIT-F total score may represent meaningful improvements. 8. On-treatment serum concentrations o | — |
Countries
Australia, Belgium, China, Czechia, France, Germany, Japan, Poland, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed