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

A Randomized (1:1), Double-blind, Parallel, Placebo-controlled Exploratory Pilot Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Systemic (po) Application of MP1032 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02908347

Enrollment

Registered

2016-09-20

Start date

2016-05-31

Completion date

2017-02-28

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis, Psoriasis

Keywords

Plaque psoriasis, chronic, moderate, severe, Plaque

Brief summary

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.

Detailed description

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).

Interventions

DRUGMP1032

hard gelatine capsules containing 50 mg MP1032 as active ingredient

DRUGPlacebo

hard gelatine capsules without active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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: 1. PASI score \> 10 at screening and 2. 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. 6. 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. 7. Patients must meet the following clinical laboratory criteria: 1. White blood cell count ≥ 3.5 x 10\^9/L 2. Platelet count ≥ 100 x 10\^9/L 3. Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate \> 60 mL/min 4. Total bilirubin ≤ 1.5 x ULN 5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN 6. Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly 7. No coagulopathy (International Normalized Ratio \[INR\] \< 1.5). 8. Patients agree not to increase normal sun exposure during the course of the study. 9. Patients are able to swallow 2 small capsules during each administration. 10. 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

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Continuously from Treatment Start until the last follow-up visit on Study Day 71	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.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Continuously from Treatment Start until the last follow-up visit on Study Day 71	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.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Continuously from Treatment Start until the last follow-up visit on Study Day 71	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.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Continuously from Treatment Start until the last follow-up visit on Study Day 71	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.
Pharmacokinetics (PK) - Plasma Concentrations	Study Days 1, 15, 29 and 43	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.
Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)	Study Day 1	Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
Pharmacokinetics (PK) - Time	Study Day 1	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
Pharmacokinetics (PK) - Area Under the Curve (AUC)	Study Day 1	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.
Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Study Day 1	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.

Secondary

Measure	Time frame	Description
Psoriasis Area Severity Index (PASI) - Observed PASI Values	Study Day 1, 43, 57 and 71	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, ).
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline	Study Day 1 and 43	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).
Psoriasis Area Severity Index (PASI) - Change From Baseline	Study Day 1 and 43	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.
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h	Study Day 1, 29 and 43	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).
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt	Study Day 1, 29 and 43	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).
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients	Study Day 1, 29 and 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. 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.
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency	Study Day 1, 29 and 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. 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, ).
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline	Study Day 1 and 43	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).
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline.	Study Day 1 and 43	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).
EQ-5D 5L Visual Analogue Scale (VAS)	Study Day 1 and 43	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).

Countries

Germany

Participant flow

Participants by arm

Arm	Count
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	23
Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	23
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	MP1032	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	0 Participants	1 Participants
Age, Categorical Between 18 and 65 years	22 Participants	23 Participants	45 Participants
Race/Ethnicity, Customized Caucasian	23 Participants	23 Participants	46 Participants
Race/Ethnicity, Customized Other	0 Participants	0 Participants	0 Participants
Region of Enrollment Germany	23 participants	23 participants	46 participants
Sex: Female, Male Female	5 Participants	6 Participants	11 Participants
Sex: Female, Male Male	18 Participants	17 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 23	0 / 23
other Total, other adverse events	14 / 23	15 / 23
serious Total, serious adverse events	0 / 23	0 / 23

Outcome results

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.

Time frame: Study Day 1

Population: PK analysis set - Per Protocol Set

Arm	Measure	Group	Value (MEAN)	Dispersion
MP1032	Pharmacokinetics (PK) - Area Under the Curve (AUC)	AUC 2h	154.161 h*ng/mL	Standard Deviation 67.048
MP1032	Pharmacokinetics (PK) - Area Under the Curve (AUC)	AUC t	139.497 h*ng/mL	Standard Deviation 63.598

Primary

Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups

Time frame: Study Day 1

Population: 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)

Arm	Measure	Group	Value (MEDIAN)
MP1032	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC 2h	84.699 h*ng/mL
MP1032	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC t	75.934 h*ng/mL
Placebo	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC t	114.1 h*ng/mL
Placebo	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC 2h	114.1 h*ng/mL
AUC_2h Subgroup 2	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC 2h	137.246 h*ng/mL
AUC_2h Subgroup 2	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC t	134.561 h*ng/mL
AUC_2h Subgroup 3	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC 2h	218.482 h*ng/mL
AUC_2h Subgroup 3	Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups	Subgroups AUC t	218.482 h*ng/mL

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

Time frame: Study Day 1

Population: PK analysis set - Per Protocol Set

Arm	Measure	Value (MEAN)	Dispersion
MP1032	Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)	235.585 ng/mL	Standard Deviation 124.726

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.

Time frame: Study Days 1, 15, 29 and 43

Population: 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.)

Arm	Measure	Group	Value (MEAN)	Dispersion
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 1 - 15 minutes postdose	190.3 ng/mL	Standard Deviation 153.537
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 1 - 30 minutes postdose	162.861 ng/mL	Standard Deviation 64.674
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 1 - 1 hour postdose	56.875 ng/mL	Standard Deviation 30.8
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 1 - 2 hours postdose	8.677 ng/mL	Standard Deviation 6.629
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 15	211.545 ng/mL	Standard Deviation 151.406
MP1032	Pharmacokinetics (PK) - Plasma Concentrations	Day 29	199.652 ng/mL	Standard Deviation 149.857

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

Time frame: Study Day 1

Population: PK analysis set - Per Protocol Set

Arm	Measure	Group	Value (MEDIAN)
MP1032	Pharmacokinetics (PK) - Time	t max	0.25 hours
MP1032	Pharmacokinetics (PK) - Time	t last	1.99 hours

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.

Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Skin and Subcutaneous Tissue Disorders	1 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Gastrointestinal disorders	0 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	General disorders - Administration Site Conditions	2 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Infections and Infestations	2 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Nervous System Disorders	0 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	All related TEAEs	5 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Nervous System Disorders	1 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	All related TEAEs	5 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Infections and Infestations	3 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Gastrointestinal disorders	2 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	Skin and Subcutaneous Tissue Disorders	2 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC	General disorders - Administration Site Conditions	0 Participants

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.

Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	All TEAEs	14 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Serious TEAEs	0 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Severe TEAEs	0 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Related TEAEs	5 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	TEAEs leading to Withdrawal	0 Participants
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	TEAEs leading to Death	0 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Related TEAEs	5 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	All TEAEs	15 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Severe TEAEs	1 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	Serious TEAEs	0 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	TEAEs leading to Withdrawal	1 Participants
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs	TEAEs leading to Death	0 Participants

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.

Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71

Arm	Measure	Group	Value (NUMBER)
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	All related TEAEs	6 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Gastrointestinal disorders	0 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	General disorders - Administration Site Conditions	2 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Infections and Infestations	2 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Nervous System Disorders	0 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Skin and Subcutaneous Tissue Disorders	2 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Nervous System Disorders	1 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	All related TEAEs	9 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Infections and Infestations	3 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Gastrointestinal disorders	3 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	Skin and Subcutaneous Tissue Disorders	2 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC	General disorders - Administration Site Conditions	0 TEAEs

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.

Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71

Arm	Measure	Group	Value (NUMBER)
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	All TEAEs	27 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Serious TEAEs	0 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Severe TEAEs	0 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Related TEAEs	6 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	TEAEs leading to Withdrawal	0 TEAEs
MP1032	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	TEAEs leading to Death	0 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	TEAEs leading to Withdrawal	1 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	All TEAEs	32 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Related TEAEs	9 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Serious TEAEs	0 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	TEAEs leading to Death	0 TEAEs
Placebo	Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs	Severe TEAEs	1 TEAEs

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).