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JNJ-66525433Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1654 Nutrition Wiki 1.00
drug1940 Psychological and Behaviour Change Support Wiki 1.00
drug880 Exercise Wiki 0.71
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D014456 Ulcer NIH 0.41
D003092 Colitis NIH 0.41
D003093 Colitis, Ulcerative NIH 0.41

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0002583 Colitis HPO 0.41
HP:0100279 Ulcerative colitis HPO 0.41

There is one clinical trial.

Clinical Trials

1 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

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).

NCT04457960 Healthy Colitis, Ulcerative Drug: JNJ-66525433 Drug: Placebo
MeSH:Colitis Colitis, Ulcerative Ulcer
HPO:Colitis Ulcerative colitis

Primary Outcomes

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 Days

Description: 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 Days

Description: 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 Days

Description: 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 Days

Description: 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 Days

Secondary Outcomes

Description: Plasma concentrations of JNJ-66525433 will be reported.

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

Time: Up to 224 Days

Description: 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 14

Description: 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 84

Description: 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 70

Description: 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 84

Description: 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 84

Description: 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 Days

Description: Tissue biopsy concentrations of JNJ-66525433 will be reported.

Measure: Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations

Time: Up to 182 Days

Related HPO nodes (Using clinical trials)

HP:0002583: Colitis
Genes 43
TTC37 RFXANK SKIV2L PLCG2 MAP3K7 NLRC4 SKIV2L IL10RA BACH2 LRBA RFX5 TNFAIP3 STAT1 FOXP3 FAS RTEL1 FASLG IL6 ZAP70 RFXAP NOD2 TGFB1 IL10RB NCF4 CASP10 XIAP FAS PRKCD TCF4 MASP2 ZAP70 RET RASGRP1 FERMT1 POLA1 CIITA INAVA OPLAH GPR35 MST1 HPS1 CARMIL2 GPIHBP1
Protein Mutations 2
H180Q V600E
SNP 0
HP:0100279: Ulcerative colitis
Genes 9
MASP2 NOD2 PLCG2 MAP3K7 INAVA GPR35 MST1 TCF4 IL6
Protein Mutations 2
H180Q V600E
SNP 1
rs2097432