Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1048 | Dialectical Behavioral Therapy (DBT) Skills Wiki | 1.00 |
| drug2505 | Placebo Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003092 | Colitis NIH | 0.35 |
| D003093 | Colitis, Ulcerative NIH | 0.35 |
| D014456 | Ulcer NIH | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002583 | Colitis HPO | 0.35 |
| HP:0100279 | Ulcerative colitis HPO | 0.35 |
Navigate: Correlations HPO
There is one clinical trial.
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).
Description: 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.
Measure: Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability Time: Up to 224 DaysDescription: Number of participants with vital sign abnormalities (temperature), pulse/heart rate, respiratory rate and blood pressure) will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Vital Sign Abnormalities Time: Up to 224 DaysDescription: Number of participants with physical examination abnormalities will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Physical Examination Abnormalities Time: Up to 224 DaysDescription: Number of participants with clinical laboratory abnormalities (serum chemistry, hematology and urinalysis) will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Clinical Laboratory Abnormalities Time: Up to 224 DaysDescription: Number of participants with ECG abnormalities will be reported.
Measure: Part 1, 2 and 3: Number of Participants with Electrocardiogram (ECG) Abnormalities Time: Up to 224 DaysDescription: Plasma concentrations of JNJ-66525433 will be reported.
Measure: Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433 Time: Up to 224 DaysDescription: Plasma concentrations of JNJ-66525433 after fasted or fed dosing will be reported.
Measure: Part 1: Plasma Concentrations of JNJ-66525433 After Fasted or Fed Dosing Time: Up to Day 14Description: 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.
Measure: Part 3: Mayo Score Time: Up to Day 84Description: 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.
Measure: Part 3: Partial Mayo Score Time: Up to Day 70Description: 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).
Measure: Part 3: Endoscopic Subscore Time: Up to Day 84Description: 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.
Measure: Part 3: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score Time: Days 1, 7, 14, 28, 43, 70 and 84Description: Levels of mRNA knockdown will be reported to assess target engagement in biopsy tissue by dose level over time.
Measure: Part 2 and 3: Target Engagement of Messenger Ribonucleic Acid (mRNA) Levels Time: Up to 182 DaysDescription: Tissue biopsy concentrations of JNJ-66525433 will be reported.
Measure: Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations Time: Up to 182 DaysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports