Moderate to severe chronic plaque psoriasis
Conditions
Interventions
Product Name: MP1032 Hard Gelatine Capsules 50 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: not available
CAS Number: 20666-12-0
Current Sponsor code: MP1032
Other descriptive name: MP10
Sponsors
MetrioPharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants legally competent to sign and give informed consent. 2.Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis: a.PASI score > 10 at screening and b.Disease duration of = 6 months at the initiation of study medication. 3.Body Mass Index (BMI) between 18.5 and 34.9 kg/m2. 4.Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician. 5.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. (See protocol section 5.8 for more details on adequate contraception). 6.Post-menopausal women with spontaneous amenorrhea for at least 12 months and serum 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. (See Section 5.8 for more details on sterile definition). 7.Patients must meet the following clinical laboratory criteria: a)White blood cell count = 3.5 x 109/L b)Platelet count = 100 x 109/L c)Serum creatinine = 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate > 60 mL/min d)Total bilirubin = 1.5 x ULN e)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 1.5 x ULN f) Hemoglobin = lower limit of normal as per local laboratory reference ranges for women and men accordingly. g)No coagulopathy (International Normalized Ratio [INR] =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 them 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) in 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 treatments with Topical psoriasis medications, Topical immunosuppressive drugs , Systemic treatment (non-biologic), Phototherapy or photochemotherapy/photosensitizing drugs, Systemic retinoids, Any Anti TNFs, Other biologics and other systemic therapies, and Rituximab (see protocol) 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 participatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and pharmacokinetics (PK) of orally administered 100 mg MP1032 twice a day (bid) when taken for 42 days by patients with moderate to severe chronic plaque psoriasis;Secondary Objective: To evaluate the efficacy of orally administered 100 mg MP1032 bid when taken for 42 days by patients with moderate to severe chronic plaque psoriasis as assessed by: - Psoriasis Area Severity Index (PASI) - Physician’s Global Assessment (PGA) - Dermatology Life Quality Index (DLQI) - EQ-5D 5L visual analogue scale (VAS) - Modified Nail Psoriasis Severity Index (mNAPSI) ;Primary end point(s): Safety Pharmacokinetics;Timepoint(s) of evaluation of this end point: Safety: Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71. Pharmacokinetics: Pharmacokinetic sampling will occur on Day 1, Day 15, Day 29 and Day 43: Day 1: at 15 minutes, 30 minutes, 1 hour, and 2 hours postdose Day 15: any time postdose (time of the last dose will be recorded) Day 29: any time postdose (time of the last dose will be recorded) Day 43: postdose (time of the last dose will be recorded). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy variables: - Psoriasis Area Severity Index (PASI) - Physician's Global Assessment (PGA) - Dermatology Life Quality Index (DLQI) - EQ-5D 5L visual analogue scale (VAS) - Modified Nail Psoriasis Severity Index (mNAPSI) ;Timepoint(s) of evaluation of this end point: All of the efficacy variables will be assessed at the screening visit (Visit 1, up to 28 days prior to randomization), during the treatment period (Days 1, 15, 29 and 43) 2 weeks after the last treatment day (Day 57) and at the End of Study Follow-up visit (Day 71) | — |
Countries
Germany
Contacts
Public ContactDr. Petra Schulz
MetrioPharm Deutschland GmbH
Outcome results
None listed