Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT03832738)
NCT ID: NCT03832738
Last Updated: 2021-08-20
Results Overview
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
COMPLETED
PHASE2
152 participants
End of Treatment (Up to 16 Weeks)
2021-08-20
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. Intent-to-Treat (ITT) Population - 152 subjects 2. Safety Population - 151 subjects 3. Pharmacokinetic (PK) Population - 101 subjects
Participant milestones
| Measure |
JTE-451 200 mg Twice Daily
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
|
Overall Study
COMPLETED
|
43
|
38
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
19
|
Reasons for withdrawal
| Measure |
JTE-451 200 mg Twice Daily
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
16
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=51 Participants
Placebo Tablets orally twice daily for 16 weeks
|
Total
n=152 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
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
44 participants
n=5 Participants
|
38 participants
n=7 Participants
|
42 participants
n=5 Participants
|
124 participants
n=4 Participants
|
|
Prior exposure to biologics therapy
Had prior biologics therapy
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Prior exposure to biologics therapy
No prior biologics therapy
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Body weight
Below 90 kg
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Body weight
90 kg or above
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=51 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) at End-of-treatment (EOT)
|
11.8 % of subjects achieving PASI-75
|
22.0 % of subjects achieving PASI-75
|
7.8 % of subjects achieving PASI-75
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=51 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects Achieving a Minimum 50% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-50) at EOT
|
33.3 % of subjects achieving PASI-50
|
42.0 % of subjects achieving PASI-50
|
17.6 % of subjects achieving PASI-50
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score at EOT (up to 16 weeks) relative to Baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=51 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects Achieving a Minimum 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-90) at EOT
|
2.0 % of subjects achieving PASI-90
|
6.0 % of subjects achieving PASI-90
|
2.0 % of subjects achieving PASI-90
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The PASI combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percent change from baseline to EOT (up to 16 weeks) in PASI score was calculated by taking the PASI score at EOT and subtracting the baseline PASI score, then dividing by the baseline PASI score and multiplying by 100.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at EOT
|
-30.33 % change in PASI Score
Standard Deviation 40.971
|
-37.89 % change in PASI Score
Standard Deviation 37.896
|
-17.53 % change in PASI Score
Standard Deviation 34.701
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptoms\] to 4 \[severe symptoms\]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe). For this outcome measure, at EOT (up to 16 weeks), a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=51 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percentage of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 at EOT
|
25.5 % of subjects achieving sPGA 0 or 1
|
28.0 % of subjects achieving sPGA 0 or 1
|
5.9 % of subjects achieving sPGA 0 or 1
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptoms\] to 4 \[severe symptoms\]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe). Change from baseline to EOT (up to 16 weeks) in sPGA score was calculated by taking the sPGA score at EOT and subtracting the baseline sPGA score.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Static Physician's Global Assessment (sPGA) Score at EOT
|
-0.96 score on a scale
Standard Deviation 0.848
|
-1.02 score on a scale
Standard Deviation 0.869
|
-0.54 score on a scale
Standard Deviation 0.713
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100). BSA (%)=0.1Sh+0.2Su+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs. Percent change from baseline to EOT (up to 16 weeks) in BSA was calculated by taking the EOT BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100. A negative change from baseline at EOT indicates a reduction in the Psoriasis BSA compared to the baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Body Surface Area (BSA) at EOT
|
-18.67 % Change in Psoriasis BSA
Standard Deviation 39.582
|
-19.03 % Change in Psoriasis BSA
Standard Deviation 48.696
|
-5.74 % Change in Psoriasis BSA
Standard Deviation 38.707
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100. Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Overall Score was calculated by taking the EOT Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score. A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in the Skindex-16 Overall Score at EOT
|
-10.029 score on a scale
Standard Deviation 23.2635
|
-10.896 score on a scale
Standard Deviation 26.7910
|
-3.386 score on a scale
Standard Deviation 20.8617
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100. Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Symptoms Scale Score was calculated by taking the EOT Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score. A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in the Skindex-16 Symptom Scale Scores at EOT
|
-8.905 score on a scale
Standard Deviation 34.2989
|
-11.500 score on a scale
Standard Deviation 31.5148
|
-2.170 score on a scale
Standard Deviation 26.0563
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100. Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Emotions Scale Score was calculated by taking the EOT Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score. A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in the Skindex-16 Emotions Scale Scores at EOT
|
-10.411 score on a scale
Standard Deviation 21.8268
|
-13.143 score on a scale
Standard Deviation 28.4467
|
-5.953 score on a scale
Standard Deviation 22.6358
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100. Change from baseline to EOT (up to 16 weeks) in the Skindex-16 Functioning Scale Score was calculated by taking the EOT Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score. A negative change from baseline at EOT indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in the Skindex-16 Functioning Scale Scores at EOT
|
-10.392 score on a scale
Standard Deviation 23.5294
|
-7.267 score on a scale
Standard Deviation 27.6823
|
-0.764 score on a scale
Standard Deviation 20.1090
|
SECONDARY outcome
Timeframe: End of Treatment (Up to 16 Weeks)Population: Subjects in the ITT Population at the EOT. The EOT value is defined as the last assessment during the treatment period (from the first dose of study drug to the last dose of study drug).
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. The Itch NRS scores were recorded by the subject using the e-diary once daily from screening through the last visit. Change from baseline to EOT (up to 16 weeks) in the Itch NRS Score was calculated by taking the Itch NRS Score (weekly average) at EOT and subtracting the baseline Itch NRS Score (weekly average).
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=48 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Change From Baseline in Itch Numeric Rating Scale (NRS) at EOT
|
-1.302 score on a scale
Standard Deviation 2.8165
|
-1.537 score on a scale
Standard Deviation 3.2634
|
-0.547 score on a scale
Standard Deviation 2.4239
|
SECONDARY outcome
Timeframe: Follow-up (Up to 20 Weeks)Population: Safety Population (151, randomized subjects who received at least one dose of study drug).
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug). The treatment-emergent adverse event (TEAE) is defined as one of the following: 1. An adverse event (AE) that occurred during the treatment period or the follow-up period. In the process of collecting the onset dates of AEs, an AE that occurs after the initiation of trial medication on Day 1 (the first day of the treatment period) should be treated as a TEAE. All AEs occurring on the day of first dose will be considered as TEAE if the time of AE occurrence relative to the dosing is unknown. 2. An AE present prior to the treatment period that worsened in severity during the treatment period or the follow-up period. 3. Any events that are present prior to the treatment period and have recovered, but recurred during the treatment period or the follow-up period should be considered as new TEAEs.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=51 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=50 Participants
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with TEAEs
|
27 Participants
|
28 Participants
|
25 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with no TEAEs
|
24 Participants
|
22 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: Subjects (75 subjects) in the PK population at Week 16 with available trough plasma concentrations of JTE-451 (subjects who received at least one dose of JTE-451 and have at least one usable JTE-451 plasma concentration measurement at Week 16).
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentration of JTE-451 in the pharmacokinetic (PK) population.
Outcome measures
| Measure |
JTE-451 200 mg Twice Daily
n=42 Participants
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=33 Participants
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
JTE-451 Trough Plasma Concentrations at Week 16
|
575 ng/mL
Standard Deviation 704
|
1210 ng/mL
Standard Deviation 1660
|
—
|
Adverse Events
JTE-451 200 mg Twice Daily
JTE-451 400 mg Twice Daily
Placebo Twice Daily
Serious adverse events
| Measure |
JTE-451 200 mg Twice Daily
n=51 participants at risk
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 participants at risk
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=50 participants at risk
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Breast Abscess
|
2.0%
1/51 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/51 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
Other adverse events
| Measure |
JTE-451 200 mg Twice Daily
n=51 participants at risk
JTE-451 200 mg orally twice daily for 16 weeks (total daily dose - 400 mg)
|
JTE-451 400 mg Twice Daily
n=50 participants at risk
JTE-451 400 mg orally twice daily for 16 weeks (total daily dose - 800 mg)
|
Placebo Twice Daily
n=50 participants at risk
Placebo Tablets orally twice daily for 16 weeks
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Investigations
Alanine Aminotransferase Increased
|
2.0%
1/51 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
6.0%
3/50 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Investigations
Blood Glucose Increased
|
3.9%
2/51 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
3.9%
2/51 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/51 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Nervous system disorders
Headache
|
7.8%
4/51 • Number of events 8 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.9%
2/51 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.8%
4/51 • Number of events 4 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
7/51 • Number of events 13 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
38.0%
19/50 • Number of events 30 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
6.0%
3/50 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 4 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
2.0%
1/50 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Number of events 4 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
10.0%
5/50 • Number of events 5 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/51 • Number of events 1 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/51 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
4.0%
2/50 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.9%
2/51 • Number of events 2 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
6.0%
3/50 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
8.0%
4/50 • Number of events 4 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
3/51 • Number of events 4 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
6.0%
3/50 • Number of events 3 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
0.00%
0/50 • Up to 20 Weeks
Subjects in the Safety Population (151, randomized subjects who received at least one dose of study drug).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60