A Phase 1b Study to Evaluate the Efficacy and Safety of JNJ-64251330, a Janus Kinase (JAK) Inhibitor, in Participants with Familial Adenomatous Polyposis - A Phase 1b Study of JNJ-64251330, a JAK Inhibitor in Participants with FAP

Janssen-Cilag0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•Inclusion Criteria:
•- Genetic diagnosis of classical familial adenomatous polyposis (FAP)
•(adenomatous polyposis coli [APC] germline mutation or obligate carrier) with
•disease involvement of the colorectum
•- At least 6 polyps greater than or equal to (>=) 2 millimeters (mm) in
•diameter in the rectum or colon
•- A female participant of childbearing potential must have a negative highly
•sensitive pregnancy test at screening and within 72 hours prior to the first
•dose of study drug and must agree to further pregnancy tests during the study
•- A male participant must agree not to donate sperm for the purpose of
•reproduction during the study and for a minimum of 90 days after receiving the
•last dose of study drug
•- Must sign an informed consent form (ICF) indicating he or she understands the
•purpose of the study and procedures required for the study and is willing to
•participate in the study. Consent is to be obtained prior to the initiation of
•any study-related tests or procedures that are not part of standard of care for
•the participant*s disease

•Exclusion Criteria:
•- Use of non-steroidal anti-inflammatory drugs (example, aspirin, ibuprofen)
•exceeding 5 days per month, or exceeding the nonprescription dose, unless
•completes a 4-week washout period prior to the first dose of study drug
•- Treatment with other FAP-directed drug therapy (including sulindac or
•celecoxib), unless completes a 4-week washout period prior to the first dose of
•study drug- History of human immunodeficiency virus (HIV)
•- History of severe, progressive, or uncontrolled renal, genitourinary,
•hepatic, hematologic, endocrine, cardiac, vascular (including increased risk of
•thrombosis), pulmonary, rheumatologic, neurologic, psychiatric, or metabolic
•disturbances, or signs and symptoms thereof
•- A history of, or ongoing, chronic or recurrent infectious disease including
•latent or active tuberculosis (TB)

发起方