A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis

NCT05014360 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1090122021-001068-1664251330COR1001
• Study Type: interventional
• Target: 42
• Locations: 7 countries
• Sites: 16

Brief Summary

The purpose of this study is to determine the effect of JNJ-64251330 in participants with Familial Adenomatous Polyposis (FAP) on colorectal polyp burden (sum of the polyp diameters).

Conditions

Adenomatous Polyposis Coli

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• Percentage Change in Number of Colon Polyps

  Baseline and Week 24

• Percentage Change in Number of Rectal Polyps

  Baseline and Week 24

• Percentage Change in Number of J-pouch Polyps

  Baseline and Week 24

• Percentage Change in Number of Duodenal Polyps

  Baseline and Week 24

• Percentage Change in Colon Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm

  Baseline and Week 24

Study Arms (1)

JNJ-64251330

EXPERIMENTAL

Participants will receive oral dose of JNJ-64251330 twice daily for 24 Weeks.

Drug: JNJ-64251330

Interventions

JNJ-64251330 DRUG

JNJ-64251330 tablets will be administered orally.

Also known as: Lorpucitinib

JNJ-64251330

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of non-steroidal anti-inflammatory drugs (example, aspirin, ibuprofen) exceeding 5 days per month or exceeding the nonprescription dose, unless the participant 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, 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (16)

City of Hope

Duarte, California, 91010, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hopital Edouard Herriot - CHU Lyon

Lyon, 69437, France

Location

APHM Hopital Timone

Marseille, 13385, France

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Pan American Center for Oncology Trials LLC

Río Piedras, 00 935, Puerto Rico

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp. Clinic I Provincial de Barcelona

Madrid, 8036, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: November 10, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); KR (4); ES (2); FR (2); DE (1); US (5); NL (1)