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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457960
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Healthy Colitis, Ulcerative Drug: JNJ-66525433 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : October 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: JNJ-66525433
Participants will receive JNJ-66525433 oral capsules.

Placebo Comparator: Placebo
Participants will receive matching placebo in Parts 1, 2 and 3.
Drug: Placebo
Participants will receive matching placebo oral capsules.




Primary Outcome Measures :
  1. Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 224 Days ]
    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.

  2. Part 1, 2 and 3: Number of Participants with Vital Sign Abnormalities [ Time Frame: Up to 224 Days ]
    Number of participants with vital sign abnormalities (temperature), pulse/heart rate, respiratory rate and blood pressure) will be reported.

  3. Part 1, 2 and 3: Number of Participants with Physical Examination Abnormalities [ Time Frame: Up to 224 Days ]
    Number of participants with physical examination abnormalities will be reported.

  4. Part 1, 2 and 3: Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to 224 Days ]
    Number of participants with clinical laboratory abnormalities (serum chemistry, hematology and urinalysis) will be reported.

  5. Part 1, 2 and 3: Number of Participants with Electrocardiogram (ECG) Abnormalities [ Time Frame: Up to 224 Days ]
    Number of participants with ECG abnormalities will be reported.


Secondary Outcome Measures :
  1. Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433 [ Time Frame: Up to 224 Days ]
    Plasma concentrations of JNJ-66525433 will be reported.

  2. Part 1: Plasma Concentrations of JNJ-66525433 After Fasted or Fed Dosing [ Time Frame: Up to Day 14 ]
    Plasma concentrations of JNJ-66525433 after fasted or fed dosing will be reported.

  3. Part 3: Mayo Score [ Time Frame: Up to Day 84 ]
    Mayo scoring system is used for assessment of ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each ranges from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12, where higher score indicates severe disease.

  4. Part 3: Partial Mayo Score [ Time Frame: Up to Day 70 ]
    Partial Mayo score is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, and physician's global assessment) and ranges from 0 to 9 points. Higher score indicates severe disease.

  5. Part 3: Endoscopic Subscore [ Time Frame: Up to Day 84 ]
    Endoscopy sub-score ranges from 0 to 3 where; 0 = normal or inactive disease; 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = severe disease (spontaneous bleeding, ulceration).

  6. Part 3: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [ Time Frame: Days 1, 7, 14, 28, 43, 70 and 84 ]
    IBDQ18 is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

  7. Part 2 and 3: Target Engagement of Messenger Ribonucleic Acid (mRNA) Levels [ Time Frame: Up to 182 Days ]
    Levels of mRNA knockdown will be reported to assess target engagement in biopsy tissue by dose level over time.

  8. Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations [ Time Frame: Up to 182 Days ]
    Tissue biopsy concentrations of JNJ-66525433 will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457960


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Georgia
Arensia Exploratory Medicine Not yet recruiting
Tbilisi, Georgia, 0112
Germany
Charité Research Organisation GmbH Recruiting
Berlin, Germany, 10117
Moldova, Republic of
Arensia Exploratory Medicine - Clinical Republican Hospital Not yet recruiting
Chisinau, Moldova, Republic of, MD-2025
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04457960    
Other Study ID Numbers: CR108764
2018-003743-29 ( EudraCT Number )
66525433IBD1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases