Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients (NCT NCT02908347)

Last Updated: 2019-01-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

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

Results posted on

2019-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient
Overall Study STARTED	23	23
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs All TEAEs	27 TEAEs	32 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs Serious TEAEs	0 TEAEs	0 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs Severe TEAEs	0 TEAEs	1 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs Related TEAEs	6 TEAEs	9 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs TEAEs leading to Withdrawal	0 TEAEs	1 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs TEAEs leading to Death	0 TEAEs	0 TEAEs	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC All related TEAEs	6 TEAEs	9 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC Gastrointestinal disorders	0 TEAEs	3 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC General disorders - Administration Site Conditions	2 TEAEs	0 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC Infections and Infestations	2 TEAEs	3 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC Nervous System Disorders	0 TEAEs	1 TEAEs	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC Skin and Subcutaneous Tissue Disorders	2 TEAEs	2 TEAEs	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs All TEAEs	14 Participants	15 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs Serious TEAEs	0 Participants	0 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs Severe TEAEs	0 Participants	1 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs Related TEAEs	5 Participants	5 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs TEAEs leading to Withdrawal	0 Participants	1 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs TEAEs leading to Death	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC All related TEAEs	5 Participants	5 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC Gastrointestinal disorders	0 Participants	2 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC General disorders - Administration Site Conditions	2 Participants	0 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC Infections and Infestations	2 Participants	3 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC Nervous System Disorders	0 Participants	1 Participants	—	—	—	—
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC Skin and Subcutaneous Tissue Disorders	1 Participants	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 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.)

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.

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Pharmacokinetics (PK) - Plasma Concentrations Day 1 - 15 minutes postdose	190.3 ng/mL Standard Deviation 153.537	—	—	—	—	—
Pharmacokinetics (PK) - Plasma Concentrations Day 1 - 30 minutes postdose	162.861 ng/mL Standard Deviation 64.674	—	—	—	—	—
Pharmacokinetics (PK) - Plasma Concentrations Day 1 - 1 hour postdose	56.875 ng/mL Standard Deviation 30.8	—	—	—	—	—
Pharmacokinetics (PK) - Plasma Concentrations Day 1 - 2 hours postdose	8.677 ng/mL Standard Deviation 6.629	—	—	—	—	—
Pharmacokinetics (PK) - Plasma Concentrations Day 15	211.545 ng/mL Standard Deviation 151.406	—	—	—	—	—
Pharmacokinetics (PK) - Plasma Concentrations Day 29	199.652 ng/mL Standard Deviation 149.857	—	—	—	—	—

PRIMARY outcome

Timeframe: Study Day 1

Population: PK analysis set - Per Protocol Set

Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)	235.585 ng/mL Standard Deviation 124.726	—	—	—	—	—

PRIMARY outcome

Timeframe: Study Day 1

Population: PK analysis set - Per Protocol Set

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

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Pharmacokinetics (PK) - Time t max	0.25 hours Interval 0.25 to 1.02	—	—	—	—	—
Pharmacokinetics (PK) - Time t last	1.99 hours Interval 1.0 to 2.05	—	—	—	—	—

PRIMARY outcome

Timeframe: Study Day 1

Population: PK analysis set - Per Protocol Set

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.

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Pharmacokinetics (PK) - Area Under the Curve (AUC) AUC 2h	154.161 h*ng/mL Standard Deviation 67.048	—	—	—	—	—
Pharmacokinetics (PK) - Area Under the Curve (AUC) AUC t	139.497 h*ng/mL Standard Deviation 63.598	—	—	—	—	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	MP1032 n=6 Participants 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	Placebo n=5 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 n=6 Participants 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 n=5 Participants 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups Subgroups AUC 2h	84.699 h*ng/mL Interval 63.87 to 103.92	114.1 h*ng/mL Interval 108.97 to 123.74	137.246 h*ng/mL Interval 124.9 to 166.22	218.482 h*ng/mL Interval 206.25 to 289.74	—	—
Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups Subgroups AUC t	75.934 h*ng/mL Interval 63.87 to 103.92	114.1 h*ng/mL Interval 108.97 to 122.12	134.561 h*ng/mL Interval 123.13 to 166.09	218.482 h*ng/mL Interval 206.83 to 289.74	—	—

SECONDARY outcome

Timeframe: Study Day 1, 43, 57 and 71

Population: Number of patients may vary between days due to drop outs or missing data points

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, ).

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - Observed PASI Values Day 1 (Treatment Start)	16.03 score on a scale Standard Deviation 7.203	17.25 score on a scale Standard Deviation 7.458	—	—	—	—
Psoriasis Area Severity Index (PASI) - Observed PASI Values Day 43 (End of Treatment)	14.03 score on a scale Standard Deviation 9.509	14.69 score on a scale Standard Deviation 8.532	—	—	—	—
Psoriasis Area Severity Index (PASI) - Observed PASI Values Day 57 (Follow Up 1)	15.28 score on a scale Standard Deviation 10.681	15.97 score on a scale Standard Deviation 8.837	—	—	—	—
Psoriasis Area Severity Index (PASI) - Observed PASI Values Day 71 (Follow Up 2)	15.21 score on a scale Standard Deviation 10.03	16.09 score on a scale Standard Deviation 9.363	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - Change From Baseline	-2.00 score on a scale Standard Deviation 3.3994	-2.56 score on a scale Standard Deviation 5.025	—	—	—	—

SECONDARY outcome

Timeframe: Study Day 1, 29 and 43

Population: 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.

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).

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo n=6 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 n=5 Participants 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 n=6 Participants 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 n=5 Participants 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set n=22 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h Day 29	-18.24 Percentage - Change from Baseline Score Standard Deviation 24.069	-6.61 Percentage - Change from Baseline Score Standard Deviation 25.575	-14.74 Percentage - Change from Baseline Score Standard Deviation 24.96	-35.46 Percentage - Change from Baseline Score Standard Deviation 22.891	-15.03 Percentage - Change from Baseline Score Standard Deviation 16.422	-14.57 Percentage - Change from Baseline Score Standard Deviation 21.5
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h Day 43	-17.83 Percentage - Change from Baseline Score Standard Deviation 29.853	3.06 Percentage - Change from Baseline Score Standard Deviation 23.42	-21.82 Percentage - Change from Baseline Score Standard Deviation 38.572	-38.31 Percentage - Change from Baseline Score Standard Deviation 28.353	-14.32 Percentage - Change from Baseline Score Standard Deviation 13.466	-15.56 Percentage - Change from Baseline Score Standard Deviation 27.181

SECONDARY outcome

Timeframe: Study Day 1, 29 and 43

Population: 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.

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo n=6 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 n=5 Participants 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 n=6 Participants 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 n=5 Participants 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set n=22 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt Day 29	-18.24 Percentage - Change from Baseline Score Standard Deviation 24.069	-6.61 Percentage - Change from Baseline Score Standard Deviation 25.575	-27.07 Percentage - Change from Baseline Score Standard Deviation 33.055	-25.18 Percentage - Change from Baseline Score Standard Deviation 19.510	-15.03 Percentage - Change from Baseline Score Standard Deviation 16.422	-14.57 Percentage - Change from Baseline Score Standard Deviation 21.5
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt Day 43	-17.83 Percentage - Change from Baseline Score Standard Deviation 29.853	3.06 Percentage - Change from Baseline Score Standard Deviation 23.42	-35.88 Percentage - Change from Baseline Score Standard Deviation 42.928	-26.59 Percentage - Change from Baseline Score Standard Deviation 24.922	-14.32 Percentage - Change from Baseline Score Standard Deviation 13.466	-15.56 Percentage - Change from Baseline Score Standard Deviation 27.181

SECONDARY outcome

Timeframe: Study Day 1, 29 and 43

Population: Number of patients may vary between days due to drop outs or missing data points

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.

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients PASI 30 - Day 29	6 participants	6 participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients PASI 50 - Day 29	2 participants	2 participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients PASI 30 - Day 43	8 participants	5 participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients PASI 50 - Day 43	3 participants	4 participants	—	—	—	—

SECONDARY outcome

Timeframe: Study Day 1, 29 and 43

Population: Number of patients may vary between days due to drop outs or missing data points

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, ).

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency PASI 30 - Day 29	22.27 percentage of participants	26.09 percentage of participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency PASI 50 - Day 29	9.09 percentage of participants	8.7 percentage of participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency PASI 30 - Day 43	34.78 percentage of participants	21.74 percentage of participants	—	—	—	—
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency PASI 50 - Day 43	13.04 percentage of participants	17.39 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline Day 1 (Baseline)	4.2 score on a scale Standard Deviation 0.8	4.4 score on a scale Standard Deviation 0.73	—	—	—	—
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline Day 43 (End of Treatment)	3.9 score on a scale Standard Deviation 1.32	4.0 score on a scale Standard Deviation 1.11	—	—	—	—
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline Change from Baseline	-0.3 score on a scale Standard Deviation 0.98	-0.4 score on a scale Standard Deviation 0.89	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	MP1032 n=22 Participants 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	Placebo n=22 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline. Day 1 (Baseline)	8.2 score on a scale Standard Deviation 3.68	8.6 score on a scale Standard Deviation 5.92	—	—	—	—
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline. Day 43 (End of Treatment)	7.1 score on a scale Standard Deviation 4.66	7.3 score on a scale Standard Deviation 5.59	—	—	—	—
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline. Change from Baseline	-1 score on a scale Standard Deviation 3.91	-1.3 score on a scale Standard Deviation 3.51	—	—	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	MP1032 n=23 Participants 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	Placebo n=23 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
EQ-5D 5L Visual Analogue Scale (VAS) Day 1 (Baseline)	73.7 score on a scale Standard Deviation 16.58	76 score on a scale Standard Deviation 11.25	—	—	—	—
EQ-5D 5L Visual Analogue Scale (VAS) Day 43 (End of Treatment)	74.8 score on a scale Standard Deviation 14.62	76.2 score on a scale Standard Deviation 12.48	—	—	—	—
EQ-5D 5L Visual Analogue Scale (VAS) Change from Baseline	1.1 score on a scale Standard Deviation 8.14	0.1 score on a scale Standard Deviation 10.6	—	—	—	—

SECONDARY outcome

Timeframe: Study Day 1 and 43

Population: Only patients with psoriatic nail disease were evaluated

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).

Outcome measures

Outcome measures
Measure	MP1032 n=17 Participants 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	Placebo n=15 Participants Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient	AUC_2h Subgroup 2 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 Subgroup 2 according to AUC2h Day 1.	AUC_2h Subgroup 3 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 Subgroup 3 according to AUC2h Day 1.	AUC_2h Subgroup 4 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 Subgroup 4 according to AUC2h Day 1.	Placebo PK Analysis Set Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient Patients from the placebo group who provided plasma for PK purposes and completed the study.
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline Day 1 (Baseline)	3.5 score on a scale Standard Deviation 1.37	4.9 score on a scale Standard Deviation 1.49	—	—	—	—
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline Day 43 (End of Treatment)	2.8 score on a scale Standard Deviation 1.64	4.8 score on a scale Standard Deviation 1.78	—	—	—	—
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline Change from Baseline	-0.8 score on a scale Standard Deviation 1.48	-0.1 score on a scale Standard Deviation 0.92	—	—	—	—

Adverse Events

MP1032

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Disclosure Officer

MetrioPharm Deutschland GmbH

Phone: +49303384395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MP1032 n=23 participants at risk 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	Placebo n=23 participants at risk Placebo: 2 capsules of Placebo are provided orally twice daily for 42 days Placebo: hard gelatine capsules without active ingredient
Vascular disorders Haematoma	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Injury, poisoning and procedural complications Injury	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Injury, poisoning and procedural complications Skin abrasion	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Investigations Aspartate aminotransferase increased	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Investigations Blood creatinine phosphokinase increased	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Nervous system disorders Headache	26.1% 6/23 • Number of events 6 • 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.	8.7% 2/23 • Number of events 2 • 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.
Nervous system disorders Migraine	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 3 • 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.
Nervous system disorders Sciatica	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
General disorders Influenza like illness	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
General disorders Feeling drunk	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Ear and labyrinth disorders Tympanic membrane perforation	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Ear and labyrinth disorders Ear pain	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhoea	8.7% 2/23 • Number of events 2 • 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.	4.3% 1/23 • Number of events 1 • 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.
Gastrointestinal disorders Epigastric discomfort	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • 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.	4.3% 1/23 • Number of events 1 • 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.
Renal and urinary disorders Leukocyturia	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Renal and urinary disorders Haematuria	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Erythema	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/23 • 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.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Number of events 2 • 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.	4.3% 1/23 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Pruritus generalized	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Number of events 1 • 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.	4.3% 1/23 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Infections and infestations Nasopharyngitis	21.7% 5/23 • Number of events 5 • 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.	26.1% 6/23 • Number of events 8 • 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.
Infections and infestations Oral herpes	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.
Infections and infestations Urinary tract infection	0.00% 0/23 • 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.	4.3% 1/23 • Number of events 1 • 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.