Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients

Inclusion Criteria

• Participants legally competent to sign and give informed consent.
• Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis:
• PASI score > 10 at screening and
• Disease duration of ≥ 6 months at the initiation of study medication.
• Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
• Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
• Women of childbearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use 2 forms of adequate contraception throughout the trial.
• Post-menopausal women with spontaneous amenorrhea for at least 12 months and serum levels follicle stimulating hormone (FSH) Levels indicating post-menopausal state as per local laboratory reference ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study. Sterilized women may be included.
• Patients must meet the following clinical laboratory criteria:
• White blood cell count ≥ 3.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate > 60 mL/min
• Total bilirubin ≤ 1.5 x ULN
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN
• Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly
• No coagulopathy (International Normalized Ratio [INR] > Last dose prior to study medication initiation (washout period)

Topical psoriasis medications (including, but not limited to corticosteroids, calcipotriene, topical vitamin D derivates, retinoids, coal tar) >> 14 days

Topical immunosuppressive drugs (tacrolimus, pimecrolimus, or anthralin) >> 14 days (Exception: Non-medicated emollients, moisturizers and sunscreens will be allowed), Use of low potency topical steroids for critical areas such as the face, genitalia, and scalp may be allowed until 24 hours prior to randomization.

Systemic treatment (non-biologic): Systemic immunosuppressant agents (eg: methotrexate, cyclosporine, azathioprine), Systemic fumarate, Systemic corticosteroids >> 28 days

Phototherapy or photochemotherapy/photosensitizing drugs >> 28 days

Systemic retinoids >> 12 weeks

Any investigational drug >> 24 weeks (systemic); 4 weeks (topical)

Any Anti-TNFs: Infliximab, adalimumab, golimumab, etanercept, etc. >> 12 weeks

Other Biologics and other systemic therapies: ustekinumab, alefacept, apremilast, Efalizumab, certolizumab pegol, secukinumab, etc. >> 24 weeks

Rituximab >> 12 months

• Drinking or ingesting grapefruit, pomegranate, grapefruit juice or grapefruit containing products within 14 days of study medication initiation.
• Planned use of any ultraviolet (UV) phototherapy or photochemotherapy/photosensitizing drugs during the course of the study and within 28 days following the last dose of the study medication.
• Patients with a history of chronic alcohol or drug abuse within 6 months of study medication initiation.
• Patients employed by MetrioPharm or a contract research organization (CRO) involved in the clinical study.
• Vulnerable patients (eg, patients kept in detention).
• Patients who are unable to communicate, read and understand the local language, or who display any other condition, which, in the Investigator's opinion, makes them unsuitable for clinical study participation.