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

Completed

• Conditions: Familial Adenomatous Polyposis; FAP; 10017991

• Registration Number: NL-OMON52152
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at<br /><br>Week 24<br /><br>- Percentage Change from Baseline in Colorectal Polyp Burden for Polyps >=2 mm<br /><br>at Week 24</p><br>