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

Exclusion Criteria

• •1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular or palmo plantar psoriasis; severe form of psoriasis arthritis, inverse form of psoriasis). Mild to moderate cases of psoriasis arthritis are allowed provided there is no impact on study objectives as determined by the Investigator.
• •2. Patients with drug-induced psoriasis.
• •3. Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
• •4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
• •5. Pregnant or lactating females or females planning to become pregnant during the study and/or within 28 days following the last dose of study medication.
• •6. Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
• •7. Known allergies to mannitol, macrophage modulators, and gelatin.
• •8. Patients with a recent history or current signs or symptoms, as determined by the Investigator, of severe, progressive viral or bacterial infections, of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease (excluding psoriasis) requiring systemic treatment or other major diseases, which are not well controlled and may interfere with the conduct of the trial.
• •9. Patients with active malignancy or history of malignancy, except for basal cell or squamous cell carcinoma and actinic keratosis. Basal cell carcinoma and small squamous cell carcinoma of the skin which have been excised according to guidelines within the last 5 years or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence are allowed.
• •10. Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening.
• •11. Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
• •12. Previous strong sun exposure (eg, sea holiday) within the 28 days before study medication initiation.
• •13. Known photo allergy and/or experienced drug-induced photo toxicity.
• •14. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
• •15. Prior Treatment: Drug class \>\> 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
• •16. Drinking or ingesting grapefruit, pomegranate, grapefruit juice or grapefruit containing products within 14 days of study medication initiation.
• •17. 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.
• •18. Patients with a history of chronic alcohol or drug abuse within 6 months of study medication initiation.
• •19. Patients employed by MetrioPharm or a contract research organization (CRO) involved in the clinical study.
• •20. Vulnerable patients (eg, patients kept in detention).
• •21. 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.