Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24 |
Percentage change from baseline in colorectal polyp burden for all polyps (the sum of the polyp diameters) at Week 24 will be reported. |
Baseline and Week 24 |
|
Primary |
Percentage Change from Baseline in Colorectal Polyp Burden for Polyps >=2 mm at Week 24 |
Percentage change from baseline in colorectal polyp burden (sum of the polyp diameters) for polyps greater than or equal to (>=) 2 millimeters (mm) at Week 24 will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Number of Colon Polyps |
Percentage change in number of colon polyps will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Number of Rectal Polyps |
Percentage change in number of rectal polyps will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Number of J-pouch Polyps |
Percentage change in number of J-pouch polyps (for participants with an ileal pouch-anal anastomosis [IPAA]) will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Number of Duodenal Polyps |
Percentage change in number of duodenal polyps will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Colon Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm |
Percentage change in colon polyp burden for all polyps, polyps >=2 mm and polyps >=5 mm will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Rectal Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm |
Percentage change in rectal polyp burden for all polyps, polyps >=2 mm and polyps >=5 mm will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in J-Pouch Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm |
Percentage change in J-Pouch polyp (for participants with an IPAA) burden for all polyps, polyps >=2 mm and polyps >=5 mm will be reported. |
Baseline and Week 24 |
|
Secondary |
Percentage Change in Duodenal Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm |
Percentage change in duodenal polyp burden for all polyps, polyps >=2 mm and polyps >=5 mm will be reported. |
Baseline and Week 24 |
|
Secondary |
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Polyposis Stage (with and Without Colon) |
Change in InSiGHT stage will be reported. Various stages are defined as: a) With Colon: Stage 0: 0-10 polyps,all less than [<]5mm); Stage 1: 20-200 polyps,most <5 mm, none, >1 centimeters[cm]; Stage 2: 200-500 polyps,<10 that are >1 cm; Stage 3: 500-1000 polyps or any number if there are 10-50 that are >1 cm and amenable to complete polypectomy; Stage 4: >1000 polyps and/or any polyps grown to confluence and not amenable to simple polypectomy, any invasive cancer; b) Without Colon: Stage 0: 0 -10 polyps, all <5 mm; Stage 1: 10-25 polyps most <5 mm, none >1 cm; Stage 2: 10-25 polyps, any >1 amenable to complete removal; Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high-grade dysplasia (HGD), even if completely excised; Stage 4: >25 polyps not amenable complete removal, or any incompletely excised sessile polyp showing HGD; any invasive cancer. |
Baseline and Week 24 |
|
Secondary |
Change in Spigelman Stage Score |
Change in Spigelman stage score will be reported. Spigelman classification system measures risk of developing duodenal cancer in familial adenomatous polyposis (FAP). It has been classified in following stages- Stage 0 (0 points); Stage 1 (1-4 points); Stage 2 (5-6 points); Stage 3 (7-8 points); and Stage 4 (9-12 points). The total score ranges from 0 to 12. The higher the score, the more severe or advanced the FAP disease in the duodenum. |
Baseline and Week 24 |
|
Secondary |
Number of Participants with Adverse Events (AEs) |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 32 weeks |
|
Secondary |
Number of Participants with AEs by Severity |
Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to AE. |
Up to 32 weeks |
|
Secondary |
Plasma Concentration of JNJ-64251330 Over Time |
Plasma samples will be analyzed to determine plasma concentrations of JNJ-64251330 using a validated specific, and sensitive liquid chromatography coupled to tandem mass spectrometry detection (LC-MS/MS). |
Up to Week 24 |
|
Secondary |
Tissue Concentration of JNJ-64251330 Over Time |
Tissue biopsy samples will be analyzed to determine tissue concentrations of JNJ-64251330 using a validated specific, and sensitive LC-MS/MS. |
Up to Week 24 |
|
Secondary |
Levels of JAK/STAT Pathway Signaling Effector Proteins including pSTAT-3 Relative to Baseline Levels in Colorectal Polyps |
Levels of Pan-janus kinase (JAK)/ signal transducer and activator of transcription (STAT) pathway signaling effector proteins including phosphorylated (p) STAT-3 relative to baseline levels in colorectal polyps will be reported. Polyp and tissue samples will be collected to monitor for changes to the JAK-STAT pathway. |
Up to Week 24 |
|