Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: JTE-451
Product Code: JTE-451
Pharmaceutical Form: Tablet
INN or Proposed INN: Not availab.
CAS Number: Not availab.
Current Sponsor code: JTE-451
Other descriptive name: JTE-451
Concent
Sponsors
Akros Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 and =70 years of age at the time of Visit 1 (Screening Visit) 2. Have a history of moderate to severe plaque psoriasis for at least 6 months prior to Visit 1 3. Subjects with moderate to severe plaque psoriasis covering =10% BSA, with a PASI =12 and sPGA score =3 at Visit 1 and Visit 2 (baseline) 4. Body Mass Index (BMI) =40 kg/m^2 at Visit 1 5. Females may participate in the study if they are either surgically sterile, or post-menopausal or if of childbearing potential, use appropriate contraception methods described in the protocol for the duration of the study and for at least 30 days after the last dose of study drug. Note: female subjects must not donate eggs for the duration of the study and for at least 12 weeks after the last dose of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. History of the discontinuation of biologic therapies (including marketed and investigational drugs) directly targeting IL-17A, IL-17A/F, IL-17 receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the Investigator’s judgement Note: If subjects discontinued these therapies due to other reasons (e.g., safety, preference of other medication, cost, insurance coverage, remission), the subjects may participate in the study according to the Investigator’s judgment. 2. Prior exposure to ROR-? inhibitors 3. Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1 Note: Subjects with psoriatic arthritis may participate in the study if criteria for cutaneous severity of psoriasis, as well as all other study restrictions required by the protocol are met. 4. History or presence 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 5. Does not meet all protocol-specified laboratory test criteria or study restrictions, including previous/concomitant medication restriction criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis compared with placebo.;Secondary Objective: Secondary Objectives: - To evaluate the safety and tolerability of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis. - To evaluate the pharmacokinetics (PK) of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.;Primary end point(s): Primary Efficacy Parameters: Proportion of subjects achieving a minimum 75% improvement from baseline in the PASI (PASI-75) at end of treatment (EOT);Timepoint(s) of evaluation of this end point: Baseline and EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Parameters: • Proportion of subjects achieving PASI-50/PASI-75/PASI-90; • Percent change from baseline in PASI; • Proportion of subjects achieving sPGA score of 0 or 1; • Change from baseline in sPGA score; • Percent change from baseline in BSA; • Change from baseline in Skindex-16; • Change from baseline in Itch Numeric Rating Scale (NRS); • Change from baseline in each domain score/questionnaire of the Skindex-16. Exploratory Efficacy Parameters: • Percent change from baseline in psoriasis scalp severity index (PSSI); • Change from baseline in Pain NRS for PsA. Exploratory Pharmacodynamic Parameters: • Change from baseline in levels of cytokines mRNA expression in the biopsy target psoriatic lesions at EOT; • Change from baseline in histopathological parameters in the biopsy target psoriatic lesion at EOT. Safety Assessments: • Number and proportion of subjects with adverse events (AEs), type and severity of AEs, change from baseline in safety laboratory, vital sign and electrocardiogram (ECG) parameters. Pharmacokinetic Assessments: • Trough plasma levels of JTE-451; • Relationship between the JTE-451 dose (exposure) and response may be assessed (exploratory). ;Timepoint(s) of evaluation of this end point: Secondary Efficacy Parameters: Weeks 2, 4, 8, 12, 16, 20 and EOT, unless otherwise stated Exploratory Efficacy Parameters: Weeks 2, 4, 8, 12, 16, 20 and EOT, unless otherwise stated Exploratory Pharmacodynamic Parameters: Baseline and EOT Safety Assessments: From baseline until Week 16 Pharmacokinetic Assessments: Trough plasma levels of JTE-451 | — |
Countries
Canada, Germany, Poland, United States
Contacts
Public ContactKala Patel
Akros Pharma Inc.
Outcome results
None listed