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

NCT04457960 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: CR1087642018-003743-2966525433IBD1001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

  An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days will be considered as TEAE.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Vital Sign Abnormalities

  Number of participants with vital sign abnormalities (temperature), pulse/heart rate, respiratory rate and blood pressure) will be reported.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Physical Examination Abnormalities

  Number of participants with physical examination abnormalities will be reported.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Hematology Laboratory Abnormalities

  Number of participants with hematology laboratory abnormalities will be reported.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Chemistry Laboratory Abnormalities

  Number of participants with chemistry laboratory abnormalities will be reported.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Urinalysis Laboratory Abnormalities

  Number of participants with abnormalities in urinalysis will be reported.

  Up to 224 Days

• Part 2 and 3: Number of Participants with Abnormalities in High Sensitivity C- Reactive Protein (hs-CRP)

  Number of participants with abnormalities in hs-CRP will be reported using a validated, high sensitivity CRP assay.

  Up to 224 Days

• Part 2 and 3: Number of Participants with Abnormalities in Fecal Calprotectin

  Assays for fecal calprotectin will be performed using a validated method.

  Up to 224 Days

• Part 2 and 3: Incidence of Enteric Pathogens in Stool Samples

  Stool culture and Clostridium difficile toxin assay will be used for enteric pathogen assessment.

  Up to 224 Days

• Part 1, 2 and 3: Number of Participants with Electrocardiogram (ECG) Abnormalities

  Number of participants with ECG abnormalities will be reported.

  Up to 224 Days

Secondary Outcomes (10)

• Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433

  Up to 224 Days

• Part 1: Plasma Concentrations of JNJ-66525433 After Fasted or Fed Dosing

  Up to Day 14

• Part 3: Mayo Score

  Up to Day 84

• Part 3: Partial Mayo Score

  Up to Day 70

• Part 3: Endoscopic Subscore

  Up to Day 84

Study Arms (2)

JNJ-66525433

EXPERIMENTAL

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.

Drug: JNJ-66525433

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JNJ-66525433 DRUG

Participants will receive JNJ-66525433 oral capsules.

JNJ-66525433

Placebo DRUG

Participants will receive matching placebo oral capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Charite Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)