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

NCT03358290 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AE051-G-16-007
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 16

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.

Conditions

Plaque Psoriasis; Skin Diseases

Keywords

JTE-051; Psoriasis

Outcome Measures

Primary Outcomes (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).

  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

Secondary Outcomes (13)

• Percent Change From Baseline in PASI Score

  Week 12

• Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)

  Week 12

• Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)

  Week 12

• Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)

  Week 12

• Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1

  Week 12

Study Arms (5)

JTE-051 Dose 1

EXPERIMENTAL

One dose of study drug by mouth daily for 12 weeks

Drug: JTE-051

JTE-051 Dose 2

EXPERIMENTAL

One dose of study drug by mouth daily for 12 weeks

Drug: JTE-051

JTE-051 Dose 3

EXPERIMENTAL

One dose of study drug by mouth daily for 12 weeks

Drug: JTE-051

JTE-051 Dose 4

EXPERIMENTAL

One dose of study drug by mouth daily for 12 weeks

Drug: JTE-051

Placebo

EXPERIMENTAL

One dose of study drug by mouth daily for 12 weeks

Drug: Placebo

Interventions

JTE-051 DRUG

Active drug tablets containing JTE-051

JTE-051 Dose 1; JTE-051 Dose 2; JTE-051 Dose 3; JTE-051 Dose 4

Placebo DRUG

Placebo tablets identical in appearance to the active drug tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (16)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

University of South Florida - Hospital

Tampa, Florida, 33612, United States

Location

Atlanta Dermatology Vein and Research Center LLC

Alpharetta, Georgia, 30022, United States

Location

Advanced Medical Research, PC

Sandy Springs, Georgia, 30328, United States

Location

Advanced Clinical Research - Dermatology Center of Canyon County

Nampa, Idaho, 83651, United States

Location

Clinical Research Advantage, Inc.

Evansville, Indiana, 47714, United States

Location

Kansas City Dermatology P.A.

Overland Park, Kansas, 66215-2309, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Karma Clinical Trials

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Mediprobe Research Inc.

London, Ontario, N5X 2P1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

David Gratton's Private Practice

Montreal, Quebec, H3H 1V4, Canada

Location

MeSH Terms

Conditions

Skin Diseases; Psoriasis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases, Papulosquamous

Limitations and Caveats

This study was terminated early as per the Sponsor decision.

Results Point of Contact

• Title: Kazuhiro Okamiya
• Organization: Akros Pharma Inc.

okamiya@akrospharma.com

609-919-6123

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 30, 2017
• Study Start: November 10, 2017
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (12)