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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358290
Recruitment Status : Terminated (Difficulty faced with enrollment in the study)
First Posted : November 30, 2017
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 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 : November 10, 2017
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: JTE-051 Dose 1
JTE-051 dose 1 for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 2
JTE-051 dose 2 for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 3
JTE-051 dose 3 for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: JTE-051 Dose 4
JTE-051 dose 4 for 12 weeks
Drug: JTE-051
Active drug tablets containing JTE-051

Experimental: Placebo
Placebo for 12 weeks
Drug: Placebo
Placebo tablets identical in appearance to the active drug tablets




Primary Outcome Measures :
  1. Proportion of subjects achieving a minimum 75% improvement from baseline in the PASI (psoriasis area and severity index) by Week 12. [ Time Frame: 12 weeks ]
    Psoriasis area and severity index combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema and plaque induration.


Secondary Outcome Measures :
  1. Percent change from baseline in PASI score and proportions of subjects achieving 50% improvement from baseline (PASI 50), 75% improvement from baseline (PASI 75), 90% improvement from baseline (PASI 90) and 100% improvement from baseline (PASI 100). [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
    Psoriasis area and severity index combines body-surface assessments and severity of desquamation, erythema and plaque induration.

  2. Proportion of subjects achieving a Static Physician's Global Assessment (sPGA) score of 0 or 1 and change in sPGA score at Weeks 2, 4, 8, 12 and 16 from baseline. [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
    The Static Physician's Global Assessment (sPGA) score (0 [clear] to 5 [severe]) is used to determine the severity of subject's psoriatic lesion graded for induration, erythema and scaling.

  3. Change from baseline in the Skindex 16 [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
    Skindex 16 is a 16-item, skin-related quality of life questionnaire based on 3 domains: symptoms, emotions and functioning. Skindex is measured on a linear scale of 100 from 0 (no effect) to 100 (effect experienced all the time).

  4. Incidence of treatment-emergent adverse events [safety and tolerability] [ Time Frame: 12 weeks ]
    Number of treatment-emergent adverse events

  5. Pharmacokinetic [ Time Frame: Weeks 2, 4, 8 and 12 ]
    Trough plasma levels of JTE-051



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) ≤38 at Visit 1.

Exclusion Criteria:

  • Medical history of treatment failure to any systemic agents for plaque psoriasis;
  • Prior exposure to more than one biologic agent treatment;
  • 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);
  • History of or at risk for destructive arthropathy (e.g., rapidly progressing osteoarthritis, osteonecrosis, spontaneous osteonecrosis of the knee, subchondral insufficiency fracture, hip dislocation and pathologic fracture) at Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358290


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

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Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT03358290     History of Changes
Other Study ID Numbers: AE051-G-16-007
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous