chronic Psoriasis Plaque moderate-to-severe MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: MP1032 hard gelatin capsules 50 mg
Product Code: MP1032
Pharmaceutical Form: Capsule, hard
CAS Number: 20666-12-0
Current Sponsor code: MP1032
Other descriptive name: MP1032
Concentratio
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 between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator): a) PASI score =10 - =20 at baseline b) BSA score: > 10% c) Stable disease duration of = 6 months at the initiation of IMP. d) topical therapy fails to control the disease 3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2. 4. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception): a) A method with less than 1% failure rate OR b) Abstinence 5. Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition) 6. Male patients who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index 60 mL/min • Total bilirubin =1.5 × ULN • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × ULN • Hemoglobin = lower limit of normal as per central laboratory reference ranges for women and men accordingly • No coagulopathy (International Normalized Ratio [INR] =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well-being of the patient and there is no impact on trial objectives as determined by the Investigator. 2. Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE inhibitors unless on a stable dose for 3 months before IMP intake. 3. Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis. 4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator. 5. Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP. 6. Male patients planning a partner pregnancy or sperm donation during the trial including follow up period. 7. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin. 8. History or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the patient at risk by trial participation or influence the outcome of the trial. Well controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism are permitted. 9. Patients with active malignancy or history of malignancy, except for basal cell and actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that have been fully treated and show no evidence of recurrence are allowed. 10. Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening. 11. Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP initiation. 12. Known photo allergy and / or experienced drug-induced photo toxicity. 13. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements. 14. Prior treatment not adhering to Table 2. 15. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy / photosensitizing drugs during the course of the trial and within 28 days/24 weeks following the last dose of the IMP. 16. Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation. 17. Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95 mm Hg (diastolic) 18. Patients who are employed by MetrioPharm, contract research organization (CRO) or clinical site involved in the clinical trial. 19. Vulnerable patients (e.g. patients kept in detention). 20. Patients who are unable to communicate, read or understand the local language, or who display another condition, which, in the Investigator’s opinion, makes them unsuitable for clinical trial participation. 21. Patient is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis;Secondary Objective: - To evaluate the effect of each oral doses of MP1032 (150 mg bid and 300 mg bid) compared to placebo on the PASI score - To evaluate the effect of each oral doses of MP1032 (150 mg bid and 300 mg bid) compared to placebo on the PGA score - To evaluate the effect of each oral doses of MP1032 (150 mg bid and 300 mg bid) compared to placebo on the BSA score - To evaluate systemic exposure of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate to severe chronic plaque psoriasis;Primary end point(s): Comparison of each (PASI): 1. Percentage of patients who achieve a 75% improvement (response) in their PASI score (PASI 75) at Week 12 (Day 84) compared to baseline treated with 300 mg bid of MP1032 compared to placebo 2. Percentage of patients who achieve a 75% improvement (response) in their PASI score (PASI 75) at Week 12 (Day 84) compared to baseline treated with 150 mg bid of MP1032 compared to placebo And comparison of each (PGA): 3. Improvement (1 or more points on a 7 Point Scale) in PGA at Week 12 (Day 84) compared to baseline treated with 300 mg bid of MP1032 compared to placebo 4. Improvement (1 or more points on a 7 Point Scale) in PGA Score at Week 12 (Day 84) compared to baseline treated with 150 mg bid of MP1032 compared to placebo 5. Adverse events, clinical laboratory, vital signs, PK data, physical examination ;Timepoint(s) of evaluation of this end point: Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients treated with 300 bid MP1032 compared to placebo who achieve PASI 50 at Week 12 (d84) • Proportion of patients treated with 150 bid MP1032 compared to placebo who achieve PASI 50 at Week 12 (d84) • PASI score and change to baseline at Week 4 (d28), 8 (d56), 12 (d84) and week 16 (d112) on the level of individual patients • Time to achieve PASI 50 and PASI 75 • Mean PASI score and change from Baseline at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112) • Mean score and change from Baseline at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112) in the PGA • Mean score and change from Baseline at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112) in the BSA • PK data analysis ;Timepoint(s) of evaluation of this end point: at Week 4 (d28), 8 (d56), and 12 (d84), 16 (d112) | — |
Countries
Germany, Poland
Contacts
Public ContactInfo
MetrioPharm Deutschland GmbH
Outcome results
None listed