Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT03358290)
NCT ID: NCT03358290
Last Updated: 2021-08-06
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 relative to Baseline.
TERMINATED
PHASE2
13 participants
Up to 12 Weeks
2021-08-06
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 during the Screening Period. 1. Total screened - 55 subjects 2. Screen failure - 42 subjects 3. Randomized - 13 subjects 4. Safety Population - 13 subjects (All subjects randomized in the study were included in the Safety Population). The study was terminated early as per the Sponsor decision.
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
|
2
|
3
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
2
|
1
|
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
Study discontinued by Sponsor
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=3 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=3 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=3 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=2 Participants
Placebo orally once daily for 12 weeks
|
Total
n=13 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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 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=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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=8 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 12 WeeksPopulation: Randomized subjects with available data at EOT (measurement at EOT is the last post-baseline measurement up to Week 12). Of the 13 randomized subjects, 1 subject in the JTE-051 150 mg group did not have any post-baseline data. Therefore, 12 subjects were included in the PASI-75 analysis at EOT.
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 relative to Baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=3 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=2 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=3 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=2 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
|
0 % of subjects achieving PASI-75
|
0 % of subjects achieving PASI-75
|
0 % of subjects achieving PASI-75
|
0 % of subjects achieving PASI-75
|
0 % of subjects achieving PASI-75
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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. Percent change was calculated by taking the Week 12 PASI score and subtracting the baseline PASI, and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in PASI Score
|
-17.51 % change in PASI Score
Standard Deviation 3.120
|
-27.69 % change in PASI Score
Standard Deviation 2.499
|
-33.33 % change in PASI Score
Standard Deviation NA
Data available only for 1 participant.
|
-34.09 % change in PASI Score
Standard Deviation 33.429
|
0.00 % change in PASI Score
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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-50 response rate is defined as at least 50 percent (%) reduction in PASI score relative to Baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)
|
0 % of subjects achieving PASI-50
|
0 % of subjects achieving PASI-50
|
0 % of subjects achieving PASI-50
|
50 % of subjects achieving PASI-50
|
0 % of subjects achieving PASI-50
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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-90 response rate is defined as at least 90 percent (%) reduction in PASI score relative to Baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)
|
0 % of subjects achieving PASI-90
|
0 % of subjects achieving PASI-90
|
0 % of subjects achieving PASI-90
|
0 % of subjects achieving PASI-90
|
0 % of subjects achieving PASI-90
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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-100 response rate is defined as 100 percent (%) reduction in PASI score relative to Baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)
|
0 % of subjects achieving PASI-100
|
0 % of subjects achieving PASI-100
|
0 % of subjects achieving PASI-100
|
0 % of subjects achieving PASI-100
|
0 % of subjects achieving PASI-100
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 \[no symptom\] to 4 \[severe symptom\]). 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, a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1
|
0 % of subjects achieving sPGA 0 or 1
|
0 % of subjects achieving sPGA 0 or 1
|
0 % of subjects achieving sPGA 0 or 1
|
50 % of subjects achieving sPGA 0 or 1
|
0 % of subjects achieving sPGA 0 or 1
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 \[no symptom\] to 4 \[severe symptom\]). 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 Week 12 in sPGA was calculated by taking the Week 12 sPGA and subtracting the baseline sPGA.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Static Physician's Global Assessment (sPGA) Score
|
0.0 score on a scale
Standard Deviation 0.00
|
-1.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
-1.5 score on a scale
Standard Deviation 0.71
|
0.0 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 + 0.2Sh+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 Week 12 in BSA was calculated by taking the Week 12 BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100. A negative change from baseline at Week 12 indicates a reduction in the Psoriasis BSA compared to the baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Body Surface Area (BSA)
|
0.00 % change in Psoriasis BSA
Standard Deviation 0.000
|
-20.02 % change in Psoriasis BSA
Standard Deviation 12.099
|
0.00 % change in Psoriasis BSA
Standard Deviation NA
Data available only for 1 participant.
|
-0.36 % change in Psoriasis BSA
Standard Deviation 0.516
|
0.00 % change in Psoriasis BSA
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 Week 12 in the Skindex-16 Overall Score was calculated by taking the Week 12 Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score. A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in the Skindex-16 Overall Score
|
-5.75 score on a scale
Standard Deviation 15.486
|
-14.10 score on a scale
Standard Deviation 28.709
|
-9.40 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
-20.80 score on a scale
Standard Deviation 20.648
|
6.20 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 Week 12 in the Skindex-16 Symptoms Scale Score was calculated by taking the Week 12 Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score. A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in the Skindex-16 Symptoms Scale Score
|
8.35 score on a scale
Standard Deviation 0.071
|
-14.60 score on a scale
Standard Deviation 56.003
|
-16.60 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
-10.40 score on a scale
Standard Deviation 14.708
|
16.60 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 Week 12 in the Skindex-16 Emotions Scale Score was calculated by taking the Week 12 Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score. A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in the Skindex-16 Emotions Scale Score
|
-9.50 score on a scale
Standard Deviation 0.000
|
-14.30 score on a scale
Standard Deviation 20.223
|
-14.30 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
-23.85 score on a scale
Standard Deviation 33.729
|
-2.40 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized subjects with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 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. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100. Change from baseline to Week 12 in the Skindex-16 Functioning Scale Score was calculated by taking the Week 12 Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score. A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=1 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in the Skindex-16 Functioning Scale Score
|
-11.65 score on a scale
Standard Deviation 49.427
|
-13.35 score on a scale
Standard Deviation 18.880
|
3.40 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
-25.00 score on a scale
Standard Deviation 7.071
|
10.00 score on a scale
Standard Deviation NA
Data available only for 1 participant.
|
SECONDARY outcome
Timeframe: Up to 16 WeeksPopulation: Subjects in the Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug).
Subjects in the Safety Population (13, subjects who were randomly assigned to treatment and who received at least one dose of study drug). The study was terminated early as per the Sponsor decision. All randomized subjects were included in the Safety Population.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=3 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=3 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=3 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=2 Participants
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with no TEAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with TEAEs
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Subjects randomized to JTE-051 treatment groups with available data at Week 12. For the JTE-051 200 mg group, number of participants analyzed is 2 (1 subject completed the study and 1 subject did not complete the study but had available Week 12 data).
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 concentrations of JTE-051 in the subjects randomized to JTE-051 treatment groups.
Outcome measures
| Measure |
JTE-051 50 mg
n=2 Participants
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=2 Participants
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=1 Participants
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=2 Participants
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
JTE-051 Trough Plasma Concentrations
|
184 ng/mL
Standard Deviation 70.7
|
51 ng/mL
Standard Deviation 72.1
|
377 ng/mL
Standard Deviation NA
Data available only for 1 participant.
|
203 ng/mL
Standard Deviation 286.4
|
—
|
Adverse Events
JTE-051 50 mg
JTE-051 100 mg
JTE-051 150 mg
JTE-051 200 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
JTE-051 50 mg
n=2 participants at risk
JTE-051 50 mg orally once daily for 12 weeks
|
JTE-051 100 mg
n=3 participants at risk
JTE-051 100 mg orally once daily for 12 weeks
|
JTE-051 150 mg
n=3 participants at risk
JTE-051 150 mg orally once daily for 12 weeks
|
JTE-051 200 mg
n=3 participants at risk
JTE-051 200 mg orally once daily for 12 weeks
|
Placebo
n=2 participants at risk
Placebo orally once daily for 12 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Investigations
Weight increased
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
33.3%
1/3 • Number of events 1 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/3 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
0.00%
0/2 • Up to 16 Weeks
The Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug) was used for safety analysis.
|
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