CLEAR-PS: Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis

• Sponsor: Akros Pharma Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03358290
• Collaborator: (none)
• Enrollment: 13
• Locations: 16
• Arms: 5
• Actual Duration (Months): 11.6
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis; Skin Diseases	Drug: JTE-051; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
• Actual Study Start Date: Nov 10, 2017
• Actual Primary Completion Date: Oct 29, 2018
• Actual Study Completion Date: Oct 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JTE-051 Dose 1 One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 2 One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 3 One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 4 One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: Placebo One dose of study drug by mouth daily for 12 weeks	Drug: Placebo; Placebo tablets identical in appearance to the active drug tablets

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT). [Up to 12 Weeks]

   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.

Secondary Outcome Measures

1. Percent Change From Baseline in PASI Score [Week 12]

   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.

2. Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI) [Week 12]

   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.

3. Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI) [Week 12]

   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.

4. Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI) [Week 12]

   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.

5. Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1 [Week 12]

   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.

6. Change From Baseline in Static Physician's Global Assessment (sPGA) Score [Week 12]

   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.

7. Percent Change From Baseline in Psoriasis Body Surface Area (BSA) [Week 12]

   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.

8. Change From Baseline in the Skindex-16 Overall Score [Week 12]

   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.

9. Change From Baseline in the Skindex-16 Symptoms Scale Score [Week 12]

   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.

10. Change From Baseline in the Skindex-16 Emotions Scale Score [Week 12]

    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.

11. Change From Baseline in the Skindex-16 Functioning Scale Score [Week 12]

    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.

12. Number of Subjects With Treatment-emergent Adverse Events [Up to 16 Weeks]

    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.

13. JTE-051 Trough Plasma Concentrations [Week 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1

• Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;

• Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;

• Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;

• Body Mass Index (BMI) ≤40 at Visit 1.

Exclusion Criteria:

• Medical history of treatment failure to any systemic agents for plaque psoriasis;

• Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;

• Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;

• History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;

• History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First OC Dermatology	Fountain Valley	California	United States	92708
2	Center For Dermatology Clinical Research, Inc.	Fremont	California	United States	94538
3	University of South Florida - Hospital	Tampa	Florida	United States	33612
4	Atlanta Dermatology Vein and Research Center LLC	Alpharetta	Georgia	United States	30022
5	Advanced Medical Research, PC	Sandy Springs	Georgia	United States	30328
6	Advanced Clinical Research - Dermatology Center of Canyon County	Nampa	Idaho	United States	83651
7	Clinical Research Advantage, Inc.	Evansville	Indiana	United States	47714
8	Kansas City Dermatology P.A.	Overland Park	Kansas	United States	66215-2309
9	Forest Hills Dermatology Group	Forest Hills	New York	United States	11375
10	Radiant Research, Inc.	Anderson	South Carolina	United States	29621
11	Clinical Research Center of the Carolinas	Charleston	South Carolina	United States	29407
12	Dermatology Treatment and Research Center	Dallas	Texas	United States	75230
13	Karma Clinical Trials	Saint John's	Newfoundland and Labrador	Canada	A1A 4Y3
14	Mediprobe Research Inc.	London	Ontario	Canada	N5X 2P1
15	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X2
16	David Gratton's Private Practice	Montreal	Quebec	Canada	H3H 1V4

Sponsors and Collaborators

• Akros Pharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 8, 2018
• Statistical Analysis Plan - Jan 15, 2019

More Information

Publications

None provided.

• Responsible Party: Akros Pharma Inc.
• ClinicalTrials.gov Identifier: NCT03358290
• Other Study ID Numbers: AE051-G-16-007
• First Posted: Nov 30, 2017
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Akros Pharma Inc.: JTE-051; Psoriasis
• Additional relevant MeSH terms: Psoriasis; Skin Diseases

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Following informed consent signing, screening procedures to confirm eligibility were performed during the Screening Period. Total screened - 55 subjects Screen failure - 42 subjects Randomized - 13 subjects 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.

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Period Title: Overall Study
STARTED	2	3	3	3	2
COMPLETED	2	2	1	1	1
NOT COMPLETED	0	1	2	2	1

Baseline Characteristics

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo	Total
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks	Total of all reporting groups
Overall Participants	2	3	3	3	2	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 50%	3 100%	3 100%	3 100%	2 100%	12 92.3%
>=65 years	1 50%	0 0%	0 0%	0 0%	0 0%	1 7.7%
Sex: Female, Male (Count of Participants)
Female	1 50%	0 0%	3 100%	2 66.7%	0 0%	6 46.2%
Male	1 50%	3 100%	0 0%	1 33.3%	2 100%	7 53.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%	0 0%	0 0%	1 33.3%	0 0%	2 15.4%
Not Hispanic or Latino	1 50%	3 100%	3 100%	2 66.7%	2 100%	11 84.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 33.3%	0 0%	0 0%	0 0%	1 7.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 33.3%	0 0%	0 0%	1 7.7%
White	2 100%	2 66.7%	2 66.7%	3 100%	2 100%	11 84.6%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	1 50%	2 66.7%	1 33.3%	1 33.3%	0 0%	5 38.5%
United States	1 50%	1 33.3%	2 66.7%	2 66.7%	2 100%	8 61.5%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
Description	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.
Time Frame	Up to 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	3	2	3	2
Number [% of subjects achieving PASI-75]	0	0	0	0	0

2. Secondary Outcome

Title	Percent Change From Baseline in PASI Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [% change in PASI Score]	-17.51 (3.120)	-27.69 (2.499)	-33.33 (NA)	-34.09 (33.429)	0.00 (NA)

3. Secondary Outcome

Title	Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Number [% of subjects achieving PASI-50]	0	0	0	50	0

4. Secondary Outcome

Title	Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Number [% of subjects achieving PASI-90]	0	0	0	0	0

5. Secondary Outcome

Title	Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Number [% of subjects achieving PASI-100]	0	0	0	0	0

6. Secondary Outcome

Title	Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Number [% of subjects achieving sPGA 0 or 1]	0	0	0	50	0

7. Secondary Outcome

Title	Change From Baseline in Static Physician's Global Assessment (sPGA) Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [score on a scale]	0.0 (0.00)	-1.0 (0.00)	0.0 (NA)	-1.5 (0.71)	0.0 (NA)

8. Secondary Outcome

Title	Percent Change From Baseline in Psoriasis Body Surface Area (BSA)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [% change in Psoriasis BSA]	0.00 (0.000)	-20.02 (12.099)	0.00 (NA)	-0.36 (0.516)	0.00 (NA)

9. Secondary Outcome

Title	Change From Baseline in the Skindex-16 Overall Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [score on a scale]	-5.75 (15.486)	-14.10 (28.709)	-9.40 (NA)	-20.80 (20.648)	6.20 (NA)

10. Secondary Outcome

Title	Change From Baseline in the Skindex-16 Symptoms Scale Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [score on a scale]	8.35 (0.071)	-14.60 (56.003)	-16.60 (NA)	-10.40 (14.708)	16.60 (NA)

11. Secondary Outcome

Title	Change From Baseline in the Skindex-16 Emotions Scale Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [score on a scale]	-9.50 (0.000)	-14.30 (20.223)	-14.30 (NA)	-23.85 (33.729)	-2.40 (NA)

12. Secondary Outcome

Title	Change From Baseline in the Skindex-16 Functioning Scale Score
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	2	1	2	1
Mean (Standard Deviation) [score on a scale]	-11.65 (49.427)	-13.35 (18.880)	3.40 (NA)	-25.00 (7.071)	10.00 (NA)

13. Secondary Outcome

Title	Number of Subjects With Treatment-emergent Adverse Events
Description	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.
Time Frame	Up to 16 Weeks

Outcome Measure Data

Analysis Population Description

Subjects in the Safety Population (subjects who were randomly assigned to treatment and who received at least one dose of study drug).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg	Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks	Placebo orally once daily for 12 weeks
Measure Participants	2	3	3	3	2
Number of subjects with TEAEs	0 0%	2 66.7%	2 66.7%	3 100%	0 0%
Number of subjects with no TEAEs	2 100%	1 33.3%	1 33.3%	0 0%	2 100%

14. Secondary Outcome

Title	JTE-051 Trough Plasma Concentrations
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	JTE-051 50 mg	JTE-051 100 mg	JTE-051 150 mg	JTE-051 200 mg
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks	JTE-051 100 mg orally once daily for 12 weeks	JTE-051 150 mg orally once daily for 12 weeks	JTE-051 200 mg orally once daily for 12 weeks
Measure Participants	2	2	1	2
Mean (Standard Deviation) [ng/mL]	184 (70.7)	51 (72.1)	377 (NA)	203 (286.4)

Adverse Events

Time Frame	Up to 16 Weeks
Adverse Event Reporting Description	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.
Arm/Group Title	JTE-051 50 mg		JTE-051 100 mg		JTE-051 150 mg		JTE-051 200 mg		Placebo
Arm/Group Description	JTE-051 50 mg orally once daily for 12 weeks		JTE-051 100 mg orally once daily for 12 weeks		JTE-051 150 mg orally once daily for 12 weeks		JTE-051 200 mg orally once daily for 12 weeks		Placebo orally once daily for 12 weeks
All Cause Mortality
	JTE-051 50 mg		JTE-051 100 mg		JTE-051 150 mg		JTE-051 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/2 (0%)
Serious Adverse Events
	JTE-051 50 mg		JTE-051 100 mg		JTE-051 150 mg		JTE-051 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	JTE-051 50 mg		JTE-051 100 mg		JTE-051 150 mg		JTE-051 200 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		2/3 (66.7%)		2/3 (66.7%)		3/3 (100%)		0/2 (0%)
Gastrointestinal disorders
Hypoaesthesia oral	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Infections and infestations
Ear infection	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastroenteritis	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Gastrointestinal infection	0/2 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Oral candidiasis	0/2 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0
Tooth abscess	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Investigations
Blood creatine phosphokinase increased	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Transaminases increased	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Weight increased	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Joint swelling	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Musculoskeletal pain	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Osteoarthritis	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Nervous system disorders
Carpal tunnel syndrome	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/2 (0%)	0
Headache	0/2 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/3 (0%)	0	0/2 (0%)	0
Somnolence	0/2 (0%)	0	0/3 (0%)	0	1/3 (33.3%)	1	0/3 (0%)	0	0/2 (0%)	0

Limitations/Caveats

This study was terminated early as per the Sponsor decision.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.