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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.
The study population will consist of 44 enrolled (40 completed) patients with moderate to severe chronic plaque psoriasis. Patients must be able to provide written consent and meet all the inclusion criteria and none of the exclusion criteria.
This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.
The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1 day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each treatment group) complete the study.
Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.
Efficacy will be assessed on 6 designated study days using the following assessments: PASI, PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP1032 | Experimental | Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days |
|
| Placebo | Experimental | Placebo to MP1032: 2 capsules of Placebo are provided orally twice daily for 42 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP1032 | Drug | hard gelatine capsules containing 50 mg MP1032 as active ingredient |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs | Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
| Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC | Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
| Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs | Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index (PASI) - Observed PASI Values | Observed PASI values. PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD, ). | Study Day 1, 43, 57 and 71 |
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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:
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:
Patients agree not to increase normal sun exposure during the course of the study.
Patients are able to swallow 2 small capsules during each administration.
Patients are considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
Exclusion Criteria:
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.
Patients with drug-induced psoriasis.
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.
Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
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.
Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
Known allergies to mannitol, macrophage modulators, and gelatin.
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.
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.
Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening.
Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
Previous strong sun exposure (eg, sea holiday) within the 28 days before study medication initiation.
Known photo allergy and/or experienced drug-induced photo toxicity.
Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anke Gauliard, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothaar Studien GmbH | Berlin | 10783 | Germany | |||
| PAREXEL International GmbH, Klinikum Westend |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP1032 | Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient |
| FG001 | Placebo | Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP1032 | Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs | Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Posted | Number | TEAEs | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
|
AE data were collected from Enrolment to Last Visit (Study Day 71). All in all in each patient AEs were collected over a period of approximately 2-3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MP1032 | Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Officer | MetrioPharm Deutschland GmbH | +49303384395 | 36 | info@metriopharm.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D008224 | Lymphoma, Follicular |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000092124 | Organizing Pneumonia |
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| ID | Term |
|---|---|
| C511308 | sodium luminolate |
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| Placebo |
| Drug |
hard gelatine capsules without active ingredient |
|
| Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
| Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC | Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
| Pharmacokinetics (PK) - Plasma Concentrations | Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded). No statistical Evaluation has been performed. | Study Days 1, 15, 29 and 43 |
| Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax) | Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose | Study Day 1 |
| Pharmacokinetics (PK) - Time | Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration | Study Day 1 |
| Pharmacokinetics (PK) - Area Under the Curve (AUC) | AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Study Day 1 |
| Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups | AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | Study Day 1 |
| Psoriasis Area Severity Index (PASI) - Change From Baseline | Change from Baseline (PASI value Day 43 - PASI value at Day 1) / Treatment difference on Day 43 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. Variables will be summarized by descriptive statistics (n, mean, SD), difference between groups is analyzed via non-parametric statistical testing. | Study Day 1 and 43 |
| Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h | The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100). The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100). Baseline = Study Day 1 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD). | Study Day 1, 29 and 43 |
| Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt | The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100). The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100). Baseline = Study Day 1 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD). | Study Day 1, 29 and 43 |
| Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients | PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. PASI 30 and PASI 50 are related to the number of patients who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1). Variables are summarized by descriptive statistics (n, mean, SD, ). Difference between groups has been analyzed via Fisher exact test. | Study Day 1, 29 and 43 |
| Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency | PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. PASI 30 and PASI 50 are related to the number of patients (responder frequency (%)) who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1). Variables are summarized by descriptive statistics (n, mean, SD, ). | Study Day 1, 29 and 43 |
| Physician's Global Assessment (PGA) - Observed Values and Change From Baseline | PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe). No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at Study Day 43 (End of Treatment). | Study Day 1 and 43 |
| Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline. | DLQI is a total score ranging from 0 (life quality is not affected) to 30 (deep impact on life quality) computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much). No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) on end of treatment (Day 43). | Study Day 1 and 43 |
| EQ-5D 5L Visual Analogue Scale (VAS) | EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 (worst imaginable) to 100 (best imaginable) No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43). | Study Day 1 and 43 |
| Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline | mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13, the higher the score the worse the outcome. No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43). | Study Day 1 and 43 |
| Berlin |
| 14050 |
| Germany |
| Klinische Forschung Dresden GmbH | Dresden | 01069 | Germany |
| Gemeinschaftspraxis Prof. Dr. Vanscheidt und Dr. Ukat | Freiburg im Breisgau | 79100 | Germany |
Placebo:
2 capsules of Placebo are provided orally twice daily for 42 days
Placebo: hard gelatine capsules without active ingredient
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MP1032 |
Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days MP1032: hard gelatine capsules containing 50 mg MP1032 as active ingredient |
| OG001 | Placebo | Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient |
|
|
| Primary | Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC | Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Posted | Number | TEAEs | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
|
|
|
| Primary | Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs | Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Posted | Count of Participants | Participants | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
|
|
|
| Primary | Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC | Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE. | Posted | Count of Participants | Participants | Continuously from Treatment Start until the last follow-up visit on Study Day 71 |
|
|
|
| Primary | Pharmacokinetics (PK) - Plasma Concentrations | Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded). No statistical Evaluation has been performed. | Participants who gave plasma for PK data and finished the study. (Data from study day 43 were not calculated since less than one-third of the individual data points were quantifiable at the nominal time point.) | Posted | Mean | Standard Deviation | ng/mL | Study Days 1, 15, 29 and 43 |
|
|
|
| Primary | Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax) | Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose | PK analysis set - Per Protocol Set | Posted | Mean | Standard Deviation | ng/mL | Study Day 1 |
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|
| Primary | Pharmacokinetics (PK) - Time | Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration | PK analysis set - Per Protocol Set | Posted | Median | Full Range | hours | Study Day 1 |
|
|
|
| Secondary | Psoriasis Area Severity Index (PASI) - Observed PASI Values | Observed PASI values. PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD, ). | Number of patients may vary between days due to drop outs or missing data points | Posted | Mean | Standard Deviation | score on a scale | Study Day 1, 43, 57 and 71 |
|
|
|
| Secondary | Psoriasis Area Severity Index (PASI) - Change From Baseline | Change from Baseline (PASI value Day 43 - PASI value at Day 1) / Treatment difference on Day 43 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. Variables will be summarized by descriptive statistics (n, mean, SD), difference between groups is analyzed via non-parametric statistical testing. | Posted | Mean | Standard Deviation | score on a scale | Study Day 1 and 43 |
|
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|
|
| Secondary | Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h | The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100). The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100). Baseline = Study Day 1 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD). | Patients of verum group were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with the lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs. | Posted | Mean | Standard Deviation | Percentage - Change from Baseline Score | Study Day 1, 29 and 43 |
|
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| Secondary | Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt | The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100). The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100). Baseline = Study Day 1 PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD). | Patients of verum group were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with the lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs. | Posted | Mean | Standard Deviation | Percentage - Change from Baseline Score | Study Day 1, 29 and 43 |
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| Secondary | Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients | PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. PASI 30 and PASI 50 are related to the number of patients who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1). Variables are summarized by descriptive statistics (n, mean, SD, ). Difference between groups has been analyzed via Fisher exact test. | Number of patients may vary between days due to drop outs or missing data points | Posted | Number | participants | Study Day 1, 29 and 43 |
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| Secondary | Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency | PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72. PASI 30 and PASI 50 are related to the number of patients (responder frequency (%)) who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1). Variables are summarized by descriptive statistics (n, mean, SD, ). | Number of patients may vary between days due to drop outs or missing data points | Posted | Number | percentage of participants | Study Day 1, 29 and 43 |
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| Secondary | Physician's Global Assessment (PGA) - Observed Values and Change From Baseline | PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe). No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at Study Day 43 (End of Treatment). | Posted | Mean | Standard Deviation | score on a scale | Study Day 1 and 43 |
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| Secondary | Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline. | DLQI is a total score ranging from 0 (life quality is not affected) to 30 (deep impact on life quality) computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much). No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) on end of treatment (Day 43). | Posted | Mean | Standard Deviation | score on a scale | Study Day 1 and 43 |
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| Secondary | EQ-5D 5L Visual Analogue Scale (VAS) | EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 (worst imaginable) to 100 (best imaginable) No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43). | Posted | Mean | Standard Deviation | score on a scale | Study Day 1 and 43 |
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| Secondary | Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline | mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13, the higher the score the worse the outcome. No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43). | Only patients with psoriatic nail disease were evaluated | Posted | Mean | Standard Deviation | score on a scale | Study Day 1 and 43 |
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| Primary | Pharmacokinetics (PK) - Area Under the Curve (AUC) | AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | PK analysis set - Per Protocol Set | Posted | Mean | Standard Deviation | h*ng/mL | Study Day 1 |
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| Primary | Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups | AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration. | PK analysis set - Per Protocol Set was divided into 4 Subgroups based on AUC levels for AUC 2h and AUC t, respectively. All patients received test product (100 mg MP1032 (= 2 capsules a 50 mg) provided orally twice daily for 42 days) | Posted | Median | Full Range | h*ng/mL | Study Day 1 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 14 |
| 23 |
| EG001 | Placebo | Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient | 0 | 23 | 0 | 23 | 15 | 23 |
| Injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood creatinine phosphokinase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
Not provided
Not provided
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| General disorders - Administration Site Conditions |
|
| Infections and Infestations |
|
| Nervous System Disorders |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Severe TEAEs |
|
| Related TEAEs |
|
| TEAEs leading to Withdrawal |
|
| TEAEs leading to Death |
|
| General disorders - Administration Site Conditions |
|
| Infections and Infestations |
|
| Nervous System Disorders |
|
| Skin and Subcutaneous Tissue Disorders |
|
| Title | Measurements |
|---|---|
|
| Day 1 - 2 hours postdose |
|
| Day 15 |
|
| Day 29 |
|
| Day 43 (End of Treatment) |
|
|
| Day 57 (Follow Up 1) |
|
|
| Day 71 (Follow Up 2) |
|
|
| Day 43 |
|
| Day 43 |
|
| PASI 50 - Day 29 |
|
|
| PASI 30 - Day 43 |
|
|
| PASI 50 - Day 43 |
|
|
| 1 |
| Superiority |
| PASI 30 - Day 43 | Fisher Exact | 0.5136 | Superiority |
| PASI 50 - Day 43 | Fisher Exact | 1 | Superiority |
| PASI 30 - Day 43 |
|
| PASI 50 - Day 43 |
|
| Change from Baseline |
|
| Change from Baseline |
|
| Change from Baseline |
|
| Change from Baseline |
|
| Subgroups AUC t |
|