A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT04457960|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Colitis, Ulcerative||Drug: JNJ-66525433 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
Participants will receive JNJ-66525433 oral capsules.
Placebo Comparator: Placebo
Participants will receive matching placebo in Parts 1, 2 and 3.
Participants will receive matching placebo oral capsules.
- 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.
- 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.
- 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.
- 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.
- 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.
- Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433 [ Time Frame: Up to 224 Days ]Plasma concentrations of JNJ-66525433 will be reported.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations [ Time Frame: Up to 182 Days ]Tissue biopsy concentrations of JNJ-66525433 will be reported.
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
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Arensia Exploratory Medicine||Not yet recruiting|
|Tbilisi, Georgia, 0112|
|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|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|