Health Condition 1: K508- Crohns disease of both small andlarge intestine
Conditions
Interventions
Intervention1: RO7790121: RO7790121 (500 mg) or placebo will be administered IV at Weeks 0, 2, 6, and 10(induction phase). RO7790121 (450 mg or 150 mg) or placebo will then be administered SC every 4
Sponsors
F. Hoffmann- La Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and females of childbearing potential who are abstinent or use contraception, and refrain from sperm or egg donation, during the treatment period and for 95 days after the final dose of drug. Confirmed diagnosis of CD with supportive clinical, endoscopic, and histopathological evidence. Moderate to severely Active CD with more than equal to 220 and less than equal to 450; SES-CD of more than equal to 6 confirmed through a centrally read endoscopy. Involvement of ileum and/or colon, with at least 4 colonic segments traversable by an endoscope or a pediatric endoscope, or 3 segments for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug. The inclusion criteria have been updated as follows (Section 5.1):â?? CD-specific inclusion criteria have been updated to clarify the timing of centrally-read endoscopy, including standard of care endoscopy performed prior to screening. â?? The reproductive inclusion criteria have been updated and a new subsection has been added to align with current CTCG guidance on contraception and pregnancy in clinical trials (Sections 5.1 and 5.3.4). Note that this additional language is not based on new information (e.g., new safety data). â?? Language around the requirements for colorectal cancer screening has been refined for clarification. â?? The prior medications inclusion criteria have been updated to more clearly define conventional therapy failure and advanced therapy failure.
Exclusion criteria
Exclusion criteria: Participant with a history of more than equal to 3 bowel resections. 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum. Diagnosis of short gut or short bowel syndrome. Presence of ileostomy, colostomy, or ileo-anal pouch. Patients with symptomatic bowel strictures, fulminant colitis, or toxic megacolon. Current diagnosis of UC or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis. Presence of abdominal or perianal abscess. Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas, or perianal fistulas with more than 3 openings and/or the anticipated need for surgery during the study (except surgery for seton placement and/or removal). Current diagnosis or suspicion of primary sclerosing cholangitis. The exclusion criteria have been updated as follows: The medical history exclusion criteria have been updated to include significant uncontrolled medical conditions or comorbidities that would confound the study results or compromise patient safety, and to clarify requirements for recording medical history and baseline conditions (Sections 5.2 and 8). â?? To ensure the safety of participants, the infection or infection risk exclusion criteria have been updated to clarify the exclusion of clinically significant infections (including infections that are opportunistic in nature), and to include guidance for the investigator re: C. difficile screening, tuberculosis, and hepatitis B/C (Sections 5.2 and 7.1). â?? The laboratory results exclusion criteria have been updated to clarify the exception to allow patients with an established diagnosis of Gilbertâ??s syndrome (with required documentation) with total bilirubin levels â?? Language regarding permitted and prohibited medications has been clarified to describe the criteria related to immunosuppressive therapies, treatment with oral traditional Chinese medicine, and IV antibiotics, and to indicate the maximum allowed daily dose of oral prednisone prior to screening endoscopy (or standard of care endoscopy) (Sections 5.2 and 6.8 [Table 7 and 8]).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of afimkibart compared with placebo in maintaining responseTimepoint: · Clinical remission, defined as CDAI 150, at Week 52 · Endoscopic response, defined as decrease in SES-CD from baseline ³ 50%, at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of afimkibart compared with placebo in inducing response CorrespondingTimepoint: · Clinical remission, as defined above, at Week 12 · Endoscopic response, as defined above, at Week 12 · Symptomatic remission, defined as SF £ 2.8 & APS £ 1 with neither score greater than baseline, at Week 12 · Endoscopic remission, defined as SES-CD = 0 to 4 with decrease from baseline ³ 2 & no subscore 1, at Week 12 · Ulcer-free endoscopy, defined as SES-CD ulcerated surface subscore of 0, at Week 12 · SF, from baseline through Week 12 · APS, from baseline through Week 12;To evaluate the efficacy of afimkibart compared with placebo in maintaining responseTimepoint: Endoscopic remission, Symptomatic remission & Corticosteroid-free clinical remission defined as clinical remission at Week 52 & no use of corticosteroids for CD at least 8 weeks prior to Week 52, Maintenance of clinical remission defined as clinical remission at both Weeks 12 & 52, Maintenance of endoscopic response defined as endoscopic response at both Weeks 12 & 52. Clinical remission & endoscopic remission as defined above at Week 52. Ulcer-free endoscopy as defined above at Week 52;To evaluate the efficacy of afimkibart compared with placebo in terms of CD-related symptoms & health-related quality of lifeTimepoint: · Bowel urgency, from baseline through Week 12 & Week 52 · Fatigue, as measured by FACIT-F, from baseline to Week 12 & Week 52 · IBDQ score, from baseline to Week 12 & Week 52;To evaluate the efficacy of afimkibart compared with placebo in TL1A biomarker defined subgroupsTimepoint: Among TL1A biomarker-defined subgroups of participants: · Clinical remission at Week 12 · Clinical remission at Week 52 · Endoscopic response at Week 12 · Endoscopic response at Week 52 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Panama, Poland, Portugal, Republic of Korea, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Taiwan, Thailand, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactHeta Khokhani
Roche Products (India) Pvt. Ltd.
Outcome results
None listed