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Difficulty faced with enrollment in the study
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Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JTE-051 Dose 1 | Experimental | One dose of study drug by mouth daily for 12 weeks |
|
| JTE-051 Dose 2 | Experimental | One dose of study drug by mouth daily for 12 weeks |
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| JTE-051 Dose 3 | Experimental | One dose of study drug by mouth daily for 12 weeks |
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| JTE-051 Dose 4 | Experimental | One dose of study drug by mouth daily for 12 weeks |
|
| Placebo | Experimental | One dose of study drug by mouth daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTE-051 | Drug | Active drug tablets containing JTE-051 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (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. | Up to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in PASI Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | United States | ||
| Center For Dermatology Clinical Research, Inc. |
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Following informed consent signing, screening procedures to confirm eligibility were performed during the Screening Period.
The study was terminated early as per the Sponsor decision.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | JTE-051 50 mg | JTE-051 50 mg orally once daily for 12 weeks |
| FG001 | JTE-051 100 mg | JTE-051 100 mg orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2018 | Apr 8, 2021 |
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| Placebo | Drug | Placebo tablets identical in appearance to the active drug tablets |
|
| Week 12 |
| Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI) | 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. | Week 12 |
| Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI) | 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. | Week 12 |
| Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI) | 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. | Week 12 |
| Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 | 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. | Week 12 |
| Change From Baseline in Static Physician's Global Assessment (sPGA) Score | 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. | Week 12 |
| Percent Change From Baseline in Psoriasis Body Surface Area (BSA) | 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. | Week 12 |
| Change From Baseline in the Skindex-16 Overall Score | 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. | Week 12 |
| Change From Baseline in the Skindex-16 Symptoms Scale Score | 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. | Week 12 |
| Change From Baseline in the Skindex-16 Emotions Scale Score | 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. | Week 12 |
| Change From Baseline in the Skindex-16 Functioning Scale Score | 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. | Week 12 |
| Number of Subjects With Treatment-emergent Adverse Events | 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. | Up to 16 Weeks |
| JTE-051 Trough Plasma Concentrations | 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. | Week 12 |
| Fremont |
| California |
| 94538 |
| United States |
| University of South Florida - Hospital | Tampa | Florida | 33612 | United States |
| Atlanta Dermatology Vein and Research Center LLC | Alpharetta | Georgia | 30022 | United States |
| Advanced Medical Research, PC | Sandy Springs | Georgia | 30328 | United States |
| Advanced Clinical Research - Dermatology Center of Canyon County | Nampa | Idaho | 83651 | United States |
| Clinical Research Advantage, Inc. | Evansville | Indiana | 47714 | United States |
| Kansas City Dermatology P.A. | Overland Park | Kansas | 66215-2309 | United States |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | United States |
| Radiant Research, Inc. | Anderson | South Carolina | 29621 | United States |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Karma Clinical Trials | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Mediprobe Research Inc. | London | Ontario | N5X 2P1 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| David Gratton's Private Practice | Montreal | Quebec | H3H 1V4 | Canada |
| FG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| FG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| FG004 | Placebo | Placebo orally once daily for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics results are reported for the Safety Population consisting of the randomized subjects who receive at least one dose of the study drug and have at least one post-randomization safety data: 13 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | JTE-051 50 mg | JTE-051 50 mg orally once daily for 12 weeks |
| BG001 | JTE-051 100 mg | JTE-051 100 mg orally once daily for 12 weeks |
| BG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| BG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| BG004 | Placebo | Placebo orally once daily for 12 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (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. | 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. | Posted | Number | % of subjects achieving PASI-75 | Up to 12 Weeks |
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| Secondary | Percent Change From Baseline in PASI Score | 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. | 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). | Posted | Mean | Standard Deviation | % change in PASI Score | Week 12 |
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| Secondary | Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI) | 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. | 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). | Posted | Number | % of subjects achieving PASI-50 | Week 12 |
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| Secondary | Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI) | 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. | 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). | Posted | Number | % of subjects achieving PASI-90 | Week 12 |
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| Secondary | Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI) | 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. | 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). | Posted | Number | % of subjects achieving PASI-100 | Week 12 |
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| Secondary | Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 | 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. | 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). | Posted | Number | % of subjects achieving sPGA 0 or 1 | Week 12 |
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| Secondary | Change From Baseline in Static Physician's Global Assessment (sPGA) Score | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Percent Change From Baseline in Psoriasis Body Surface Area (BSA) | 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. | 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). | Posted | Mean | Standard Deviation | % change in Psoriasis BSA | Week 12 |
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| Secondary | Change From Baseline in the Skindex-16 Overall Score | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in the Skindex-16 Symptoms Scale Score | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in the Skindex-16 Emotions Scale Score | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in the Skindex-16 Functioning Scale Score | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Number of Subjects With Treatment-emergent Adverse Events | 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. | Subjects in the Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug). | Posted | Count of Participants | Participants | Up to 16 Weeks |
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| Secondary | JTE-051 Trough Plasma Concentrations | 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. | 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). | Posted | Mean | Standard Deviation | ng/mL | Week 12 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JTE-051 50 mg | JTE-051 50 mg orally once daily for 12 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | JTE-051 100 mg | JTE-051 100 mg orally once daily for 12 weeks | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Placebo | Placebo orally once daily for 12 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
This study was terminated early as per the Sponsor decision.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kazuhiro Okamiya | Akros Pharma Inc. | 609-919-6123 | okamiya@akrospharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2019 | Apr 8, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D017444 | Skin Diseases, Papulosquamous |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
JTE-051 150 mg orally once daily for 12 weeks
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
JTE-051 150 mg orally once daily for 12 weeks
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
JTE-051 150 mg orally once daily for 12 weeks
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG002 |
| JTE-051 150 mg |
JTE-051 150 mg orally once daily for 12 weeks |
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| OG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
JTE-051 100 mg orally once daily for 12 weeks
| OG002 | JTE-051 150 mg | JTE-051 150 mg orally once daily for 12 weeks |
| OG003 | JTE-051 200 mg | JTE-051 200 mg orally once daily for 12 weeks |
| OG004 | Placebo | Placebo orally once daily for 12 weeks |
|
|
| Placebo |
Placebo orally once daily for 12 weeks |
|
|
|
|