A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

NCT ID: NCT04457960

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-10-13

Brief Summary

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).

Conditions

Healthy; Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-66525433

Participants will receive JNJ-66525433 in increasing dose level 1 to dose level 4 in Parts 1, 2, and dose level 3 in part 3.

Group Type: EXPERIMENTAL

JNJ-66525433

Intervention Type: DRUG

Participants will receive JNJ-66525433 oral capsules.

Placebo

Participants will receive matching placebo in Parts 1, 2 and 3.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo oral capsules.

Interventions

JNJ-66525433

Participants will receive JNJ-66525433 oral capsules.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo oral capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For Part 1 and Part 2, healthy volunteers

• Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height), inclusive, and a body weight of no less than 50 kilogram (kg) and maximum weight of 100 kg
• Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission

For Part 3, participants with ulcerative colitis (UC)

• Have a clinical diagnosis of UC at least 3 months before screening
• Have moderately to severely active UC, defined as a Week 0 mayo score of 6 to 12, inclusive, based on central read of the video endoscopy performed during the screening
• Have a greater than or equal to (>=) 2 endoscopy subscore of the Week 0 mayo score based on central read of the video endoscopy performed during the screening

Exclusion Criteria

For Part 1 and Part 2, healthy volunteers

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Known allergies, hypersensitivity, or intolerance to antisense oligonucleotides, JNJ-66525433 or its excipients

For Part 3, participants with UC

• Has UC limited to the rectum only or to <20 centimeter (cm) of the colon evaluated by endoscopy at screening
• Presence of a stoma
• Presence or history of a fistula at any time

COVID-related

• If a participant is excluded due to recent Coronavirus disease (COVID-19) related features, the reason for screen failure should be documented in the case report form under the exclusion criterion of having a condition for which participation would not be in the participant's interest or could confound study assessments
• The field of COVID-related testing (for presence of, and immunity to, the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations / guidance from authorities / standards of care

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Charite Research Organisation GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2018-003743-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

66525433IBD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108764

Identifier Type: -

Identifier Source: org_study_id