Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis (NCT NCT02919475)
NCT ID: NCT02919475
Last Updated: 2021-06-14
Results Overview
Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at EOT (up to Week 12) compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Up to 12 Weeks
Results posted on
2021-06-14
Participant Flow
Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.
Following informed consent signing, screening procedures to confirm eligibility were performed. 1. Total screened - 528 subjects 2. Screen failure - 268 subjects 3. Randomized Population - 259 subjects (excluded 1 randomized subject due to site scientific misconduct) 4. Intent-to-Treat Population - 257 subjects (excluded 2 randomized subjects: 1 was not dosed and 1 had no post-dose measurement) 5. Safety Population - 258 subjects (excluded 1 randomized subject: 1 was not dosed)
Participant milestones
| Measure |
JTE-051 50 mg
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
51
|
52
|
|
Overall Study
Started Dosing
|
51
|
52
|
52
|
51
|
52
|
|
Overall Study
COMPLETED
|
46
|
44
|
47
|
38
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
5
|
13
|
4
|
Reasons for withdrawal
| Measure |
JTE-051 50 mg
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
3
|
9
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
2
|
2
|
|
Overall Study
Inclusion/Exclusion Criteria Not Met
|
1
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
JTE-051 50 mg
n=51 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=51 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=52 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=51 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=52 Participants
Placebo orally once daily for 12 weeks
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
223 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
211 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
133 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
124 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
163 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
62 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 12 WeeksPopulation: Subjects in the Intent-to-Treat (ITT) population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at EOT (up to Week 12).
Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at EOT (up to Week 12) compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Outcome measures
| Measure |
JTE-051 50 mg
n=51 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=51 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=50 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=51 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=52 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT)
|
27 Participants
|
31 Participants
|
27 Participants
|
30 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=47 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12
|
26 Participants
|
28 Participants
|
25 Participants
|
24 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
Percentage of subjects achieving at least 50% improvement from baseline (ACR50) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 50% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=47 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12
|
10 Participants
|
12 Participants
|
8 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
Percentage of subjects achieving at least 70% improvement from baseline (ACR70) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 70% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=47 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
The SDAI Scores indicate how active a patient's rheumatoid arthritis (RA) is currently. The SDAI is the sum of 5 outcome parameters: tender joint score (0 to 28), swollen joint score (0 to 28), Patient's Global Score of disease activity (0 to 10), Physician's Global Score of disease activity (0 to 10) and C-reactive protein (CRP, 0 to 10).General SDAI Score Interpretation is as follows: 0.0 - 3.3 Remission 3.4 - 11.0 Low Activity 11.1 - 26.0 Moderate Activity 26.1 - 86.0 High Activity
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=46 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
|
-18.14 Score on a scale
Standard Deviation 15.437
|
-21.68 Score on a scale
Standard Deviation 13.275
|
-19.41 Score on a scale
Standard Deviation 16.446
|
-19.97 Score on a scale
Standard Deviation 14.244
|
-17.66 Score on a scale
Standard Deviation 16.816
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
The CDAI is a useful clinical composite score for following patients with rheumatoid arthritis (RA). The CDAI is the sum of 4 outcome parameters: tender joint score (0 to 28), swollen joint score (0 to 28), Patient's Global Score of disease activity (0 to 10) and Physician's Global Score of disease activity (0 to 10). The CDAI Score Interpretation is as follows: 0 to 2.8: Remission 2.9 to 10: Low Disease Activity 10.1 to 22: Moderate Disease Activity 22.1 to 76: High Disease Activity
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=47 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
|
-18.76 Score on a scale
Standard Deviation 14.768
|
-22.40 Score on a scale
Standard Deviation 13.469
|
-21.02 Score on a scale
Standard Deviation 16.153
|
-21.24 Score on a scale
Standard Deviation 14.208
|
-17.19 Score on a scale
Standard Deviation 15.548
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consists of composite score of following variables: 28 tender joint count (TJC28) ranging from 0 to 28, 28 swollen joint count (SJC28) ranged from 0 to 28, C-reactive protein (CRP) (milligrams per liter) and subject's global assessment of disease activity (SGA) ranging from 0 (no disease activity) to 10 (extremely active disease). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*SGA+0.96. DAS28-CRP ranged from 0.96-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=46 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12
|
-0.95 Score on a scale
Standard Deviation 1.039
|
-1.23 Score on a scale
Standard Deviation 0.979
|
-1.03 Score on a scale
Standard Deviation 1.123
|
-1.10 Score on a scale
Standard Deviation 0.987
|
-0.98 Score on a scale
Standard Deviation 1.123
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] in 8 functional area categories: (1) dressing and grooming; (2) arising; (3) eating; (4) walking; (5) hygiene; (6) reaching; (7) gripping; and (8) performing other daily activities. Scores from each functional area category (total 8 categories) were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Outcome measures
| Measure |
JTE-051 50 mg
n=46 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=45 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=47 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=38 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=48 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12
|
-0.52 Score on a scale
Standard Deviation 0.600
|
-0.71 Score on a scale
Standard Deviation 0.629
|
-0.60 Score on a scale
Standard Deviation 0.620
|
-0.80 Score on a scale
Standard Deviation 0.727
|
-0.47 Score on a scale
Standard Deviation 0.616
|
SECONDARY outcome
Timeframe: Up to 16 WeeksPopulation: Subjects in the Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug). The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
Subjects in the Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug). The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
Outcome measures
| Measure |
JTE-051 50 mg
n=51 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=52 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=52 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=51 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=52 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-related Adverse Events
Number of subjects with TEAEs
|
26 Participants
|
21 Participants
|
32 Participants
|
34 Participants
|
22 Participants
|
|
Number of Subjects With Treatment-related Adverse Events
Number of subjects with no TEAEs
|
25 Participants
|
31 Participants
|
20 Participants
|
17 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects in the Pharmacokinetic (PK) population (received at least one dose of JTE-051 and have at least one usable JTE-051 plasma concentration measurement) with available trough plasma concentrations of JTE-051 at Week 12.
Outcome measures
| Measure |
JTE-051 50 mg
n=40 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=42 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=40 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=35 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
|
119 ng/mL
Standard Deviation 96.9
|
178 ng/mL
Standard Deviation 156
|
312 ng/mL
Standard Deviation 252
|
354 ng/mL
Standard Deviation 281
|
—
|
Adverse Events
JTE-051 50 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
JTE-051 100 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
JTE-051 150 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
JTE-051 200 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JTE-051 50 mg
n=51 participants at risk
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=52 participants at risk
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=52 participants at risk
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=51 participants at risk
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=52 participants at risk
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/Diffused abdominal pain
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Infections and infestations
Appendicitis
|
2.0%
1/51 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Infections and infestations
Cellulitis/Cellulitis in right hand
|
2.0%
1/51 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Infections and infestations
Pneumonia/Bilateral pneumonia
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis/Exacerbation of rheumatoid arthritis
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Psychiatric disorders
Insomnia/Sleep Disorders: Insomnia
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
2.0%
1/51 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
Other adverse events
| Measure |
JTE-051 50 mg
n=51 participants at risk
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=52 participants at risk
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=52 participants at risk
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=51 participants at risk
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=52 participants at risk
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/51 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
5.8%
3/52 • Number of events 3 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
3.9%
2/51 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
3/51 • Number of events 3 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
11.5%
6/52 • Number of events 6 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
3.9%
2/51 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
7.7%
4/52 • Number of events 4 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/51 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • Number of events 3 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
5.8%
3/52 • Number of events 3 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
9.6%
5/52 • Number of events 5 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
15.7%
8/51 • Number of events 8 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
3.8%
2/52 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
|
Nervous system disorders
Dysgeusia
|
3.9%
2/51 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
1.9%
1/52 • Number of events 1 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
3.8%
2/52 • Number of events 2 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
17.6%
9/51 • Number of events 9 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
0.00%
0/52 • Up to 16 weeks
The Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis. The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications at least 60 days prior to public release. The sponsor will have a review period of 60 days and can embargo communications regarding trial results for an additional period of 60 days from the end of sponsor review period. The sponsor may require removal of any and all confidential information (other than study results) in the communication.
- Publication restrictions are in place
Restriction type: OTHER