Digestive System
Conditions
Interventions
External Placebo
Sponsors
F. Hoffmann La RocheLtd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Signed Informed Consent Form by parent or legal guardian ? Ability and willingness to comply with all aspects of the protocol including completion of procedures, questionnaires, and assessments for the duration of the study ? Age = 2 and < 18 years at the time of signing Informed Consent Form (and assent form) ? Body weight = 10 kg ? Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence ? Active CD confirmed by endoscopy (ileocolonoscopy) ? Moderately to severely active CD, defined as a PCDAI score = 30, and SES-CD = 6 (or = 4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy ? For female participants of childbearing potential (see Section 5.4.1 of the clinical protocol): agreement to remain abstinent (refrain from heterosexual intercourse) or use an acceptable method of contraception and agree to refrain from egg donation or undergoing fertility treatment during the treatment period and for 95 days after the final dose of afimkibart ? Must have had at least one of the prescribed treatments in the past with inadequate response, loss of response, and/or intolerance
Exclusion criteria
Exclusion criteria: ? Monogenic disorder pertaining to infant onset IBD ? History of = 3 bowel resections ? Diagnosis of short gut or short bowel syndrome • Symptomatic bowel strictures, fulminant colitis, or toxic megacolon • Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease • Presence of abdominal or perianal abscess • Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas, or perianal fistulas with > 3 openings and/or the anticipated need for surgery during the study (except surgery for seton placement and/or removal) ? Presence of an ostomy or ileoanal pouch ? Current diagnosis or suspicion of primary sclerosing cholangitis. ? Poor peripheral venous access. ? Any major surgery within 6 weeks prior to screening or a major planned surgery during the study. ? Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders [excluding CD]), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise participant safety, or compliance with trial procedures. ? Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 95 days after the final dose of afimkibart ? Any condition precluding endoscopic evaluation ? History of malignancy within 5 years prior to screening visit ? History of alcohol, drug, or chemical abuse < 1 year prior to screening endoscopy ? History of blood transfusion within 30 days prior to screening endoscopy or between screening endoscopy and randomization ? Any clinically significant infection < 4 weeks prior to randomization that has not resolved, and/or that required hospitalization and/or IV antibiotics ? Evidence of, or treatment for, Clostridioides difficile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of afimkibart in maintaining remission | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of afimkibart in inducing response;To evaluate the efficacy of afimkibart in maintaining response;To evaluate the safety of afimkibart;To characterize the pharmacokinetics of afimkibart | — |
Countries
South Africa
Contacts
Public ContactNathaniel Ramuthaga
Clinical Operations Portfolio Leader
Outcome results
None listed