Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis (NCT NCT03706209)

Last Updated: 2024-11-22

Results Overview

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

155 participants

Primary outcome timeframe

Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Results posted on

2024-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	150 mg MP1032 Bid 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Overall Study STARTED	52	48	55
Overall Study COMPLETED	36	39	39
Overall Study NOT COMPLETED	16	9	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient	Total n=154 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	46 Participants n=7 Participants	52 Participants n=5 Participants	146 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	30 Participants n=7 Participants	35 Participants n=5 Participants	106 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	51 Participants n=5 Participants	48 Participants n=7 Participants	55 Participants n=5 Participants	154 Participants n=4 Participants
Race/Ethnicity, Customized other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Poland	39 Participants n=5 Participants	34 Participants n=7 Participants	40 Participants n=5 Participants	113 Participants n=4 Participants
Region of Enrollment Germany	12 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants

PRIMARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Population: The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 75 - Week 12 (EoT) Responder	4 Participants	4 Participants	1 Participants
PASI 75 - Week 12 (EoT) Non-Responder	46 Participants	43 Participants	53 Participants

PRIMARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Improvement - Week 12 (EoT) Responder	14 Participants	14 Participants	10 Participants
PGA Improvement - Week 12 (EoT) Non-Responder	36 Participants	33 Participants	44 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Population: The valid-cases-set (VCS) included all patients from the full-analysis-set (FAS), who completed the assessment of the co-primary endpoints without any protocol violation interfering with the precise evaluation of treatment efficacy and with sufficient exposure to IMP.

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo in the valid cases set (VCS). The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=32 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=36 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=34 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 75 VCS - Week 12 (EoT) Responder	3 Participants	3 Participants	1 Participants
PASI 75 VCS - Week 12 (EoT) Non-Responder	29 Participants	33 Participants	33 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo in the valid-cases-set (VCS). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=32 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=36 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=34 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Improvement VCS - Week 12 (EoT) Responder	9 Participants	13 Participants	8 Participants
PGA Improvement VCS - Week 12 (EoT) Non-Responder	23 Participants	23 Participants	26 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at End-of-Treatment (EoT) compared to baseline.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 50 - Week 12 (EoT) Responder	8 Participants	10 Participants	6 Participants
PASI 50 - Week 12 (EoT) Non-Responder	42 Participants	37 Participants	48 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at end of treatment (EoT) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI ANCOVA Change From Baseline - Week 12 (EoT)	0.1 score on a scale (PASI baseline change) Standard Error 1.0	-1.1 score on a scale (PASI baseline change) Standard Error 1.0	-0.1 score on a scale (PASI baseline change) Standard Error 1.0

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI Descriptive Statistics - Week 12 (EoT) Day 1	14.7 score on a scale (PASI) Standard Deviation 2.8	14.2 score on a scale (PASI) Standard Deviation 2.7	13.8 score on a scale (PASI) Standard Deviation 2.5
PASI Descriptive Statistics - Week 12 (EoT) Week 12 (EoT)	15 score on a scale (PASI) Standard Deviation 9.1	13 score on a scale (PASI) Standard Deviation 9	13.5 score on a scale (PASI) Standard Deviation 6
PASI Descriptive Statistics - Week 12 (EoT) Week 12 (EoT) - change from baseline	0.3 score on a scale (PASI) Standard Deviation 8.4	-1.2 score on a scale (PASI) Standard Deviation 7.6	-0.3 score on a scale (PASI) Standard Deviation 5.5

SECONDARY outcome

Timeframe: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)

Time to the achievement of PASI 75, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed is the number of responders that reached an improvement of at least 75% in the PASI score in the respective week.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Time to PASI 75 Week 4	0 Participants	1 Participants	2 Participants
Time to PASI 75 Week 8	2 Participants	0 Participants	0 Participants
Time to PASI 75 Week 12 (EoT)	3 Participants	3 Participants	1 Participants
Time to PASI 75 Week 16 (FU)	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)

Time to the achievement of PASI 50, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed is the number of responders that reached an improvement of at least 50% in the PASI score in the respective week.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Time to PASI 50 Week 4	2 Participants	7 Participants	5 Participants
Time to PASI 50 Week 8	4 Participants	3 Participants	2 Participants
Time to PASI 50 Week 16 (FU)	1 Participants	3 Participants	2 Participants
Time to PASI 50 Week 12 (EoT)	4 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). For change from baseline negative values indicate improvement.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Descriptive Statistics - Week 12 (EoT) Week 12 (EoT)	4.0 score on a scale (PGA) Standard Deviation 1.3	3.8 score on a scale (PGA) Standard Deviation 1.2	4.1 score on a scale (PGA) Standard Deviation 1.0
PGA Descriptive Statistics - Week 12 (EoT) Week 12 (EoT) - change from baseline	-0.1 score on a scale (PGA) Standard Deviation 1.1	-0.4 score on a scale (PGA) Standard Deviation 1.0	-0.0 score on a scale (PGA) Standard Deviation 0.8
PGA Descriptive Statistics - Week 12 (EoT) Day 1	4.1 score on a scale (PGA) Standard Deviation 0.7	4.2 score on a scale (PGA) Standard Deviation 0.7	4.1 score on a scale (PGA) Standard Deviation 0.7

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The 7-point's assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Frequency of the scores from 0 to 6 at end of treatment in the different treatment groups is displayed.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Frequency Counts - Week 12 (EoT) 0 - Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Week 12 (EoT) 2 - Mild	6 Participants	7 Participants	4 Participants
PGA Frequency Counts - Week 12 (EoT) 3 - Mild to Moderate	10 Participants	9 Participants	11 Participants
PGA Frequency Counts - Week 12 (EoT) 5 - Moderate to Severe	12 Participants	13 Participants	18 Participants
PGA Frequency Counts - Week 12 (EoT) 1 - Almost Clear	1 Participants	1 Participants	0 Participants
PGA Frequency Counts - Week 12 (EoT) 4 - Moderate	15 Participants	15 Participants	18 Participants
PGA Frequency Counts - Week 12 (EoT) 6 - Severe	6 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
BSA Descriptive Statistics - Week 12 (EoT) Week 12 (EoT) - change from baseline	1.2 percentage of body surface area Standard Deviation 9.4	0.5 percentage of body surface area Standard Deviation 11.3	-0.2 percentage of body surface area Standard Deviation 5.3
BSA Descriptive Statistics - Week 12 (EoT) Day 1	19 percentage of body surface area Standard Deviation 8.8	19.2 percentage of body surface area Standard Deviation 10.5	17.5 percentage of body surface area Standard Deviation 6.3
BSA Descriptive Statistics - Week 12 (EoT) Week 12 (EoT)	20.2 percentage of body surface area Standard Deviation 13	19.7 percentage of body surface area Standard Deviation 17.2	17.3 percentage of body surface area Standard Deviation 8.7

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 75 - Week 4 Responder	0 Participants	1 Participants	2 Participants
PASI 75 - Week 4 Non-Responder	50 Participants	46 Participants	52 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 75 - Week 8 Responder	2 Participants	1 Participants	1 Participants
PASI 75 - Week 8 Non-Responder	48 Participants	46 Participants	53 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 75 - Week 16 (FU) Responder	4 Participants	5 Participants	2 Participants
PASI 75 - Week 16 (FU) Non-Responder	34 Participants	35 Participants	42 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 50 - Week 4 Responder	2 Participants	7 Participants	5 Participants
PASI 50 - Week 4 Non-Responder	48 Participants	40 Participants	49 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 50 - Week 8 Responder	5 Participants	9 Participants	7 Participants
PASI 50 - Week 8 Non-Responder	45 Participants	38 Participants	47 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI 50 - Week 16 (FU) Responder	8 Participants	10 Participants	6 Participants
PASI 50 - Week 16 (FU) Non-Responder	30 Participants	30 Participants	38 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 4) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI ANCOVA Change From Baseline - Week 4	-0.3 score on a scale (PASI baseline change) Standard Error 0.7	-1.7 score on a scale (PASI baseline change) Standard Error 0.7	-0.6 score on a scale (PASI baseline change) Standard Error 0.7

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies with a maximum value of 72 points, any value higher than 10 is considered as moderate to severe psoriasis. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 8) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI ANCOVA Change From Baseline - Week 8	0.2 score on a scale (PASI baseline change) Standard Error 0.9	-1.8 score on a scale (PASI baseline change) Standard Error 0.9	-0.8 score on a scale (PASI baseline change) Standard Error 0.8

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 16, FU) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI ANCOVA Change From Baseline - Week 16 (FU)	-0.3 score on a scale (PASI baseline change) Standard Error 1.3	-0.8 score on a scale (PASI baseline change) Standard Error 1.2	-0.8 score on a scale (PASI baseline change) Standard Error 1.2

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI Descriptive Statistics - Week 4 Week 4 - change from baseline	-0.2 score on a scale (PASI) Standard Deviation 6.3	-1.8 score on a scale (PASI) Standard Deviation 4.2	-0.7 score on a scale (PASI) Standard Deviation 4.1
PASI Descriptive Statistics - Week 4 Day 1	14.7 score on a scale (PASI) Standard Deviation 2.8	14.2 score on a scale (PASI) Standard Deviation 2.7	13.8 score on a scale (PASI) Standard Deviation 2.5
PASI Descriptive Statistics - Week 4 Week 4	14.5 score on a scale (PASI) Standard Deviation 7.1	12.4 score on a scale (PASI) Standard Deviation 5.5	13.1 score on a scale (PASI) Standard Deviation 4.6

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI Descriptive Statistics - Week 8 Day 1	14.7 score on a scale (PASI) Standard Deviation 2.8	14.2 score on a scale (PASI) Standard Deviation 2.7	13.8 score on a scale (PASI) Standard Deviation 2.5
PASI Descriptive Statistics - Week 8 Week 8	15.1 score on a scale (PASI) Standard Deviation 8.1	12.3 score on a scale (PASI) Standard Deviation 7.8	12.8 score on a scale (PASI) Standard Deviation 5.4
PASI Descriptive Statistics - Week 8 Week 8 - change from baseline	0.4 score on a scale (PASI) Standard Deviation 7.4	-1.9 score on a scale (PASI) Standard Deviation 6.4	-1 score on a scale (PASI) Standard Deviation 4.9

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PASI Descriptive Statistics - Week 16 (FU) Week 16 (FU) - change from baseline	0.3 score on a scale (PASI) Standard Deviation 9	-0.7 score on a scale (PASI) Standard Deviation 9.6	-1.2 score on a scale (PASI) Standard Deviation 4.7
PASI Descriptive Statistics - Week 16 (FU) Week 16 (FU)	15.1 score on a scale (PASI) Standard Deviation 9.3	13.6 score on a scale (PASI) Standard Deviation 11	12.3 score on a scale (PASI) Standard Deviation 5.1

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Improvement - Week 4 Responder	11 Participants	13 Participants	9 Participants
PGA Improvement - Week 4 Non-Responder	39 Participants	34 Participants	45 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Improvement - Week 8 Responder	12 Participants	16 Participants	14 Participants
PGA Improvement - Week 8 Non-Responder	38 Participants	31 Participants	40 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Improvement - Week 16 (FU) Responder	14 Participants	13 Participants	12 Participants
PGA Improvement - Week 16 (FU) Non-Responder	24 Participants	27 Participants	32 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Descriptive Statistics - Week 4 Day 1	4.1 PGA score Standard Deviation 0.7	4.2 PGA score Standard Deviation 0.7	4.1 PGA score Standard Deviation 0.7
PGA Descriptive Statistics - Week 4 Week 4	3.9 PGA score Standard Deviation 0.9	3.9 PGA score Standard Deviation 0.9	4.0 PGA score Standard Deviation 1.0
PGA Descriptive Statistics - Week 4 Week 4 - change from baseline	-0.1 PGA score Standard Deviation 0.7	-0.3 PGA score Standard Deviation 0.6	-0.1 PGA score Standard Deviation 0.6

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Descriptive Statistics - Week 8 Day 1	4.1 PGA score Standard Deviation 0.7	4.2 PGA score Standard Deviation 0.7	4.1 PGA score Standard Deviation 0.7
PGA Descriptive Statistics - Week 8 Week 8	4.0 PGA score Standard Deviation 1.1	3.8 PGA score Standard Deviation 1.1	3.9 PGA score Standard Deviation 1.1
PGA Descriptive Statistics - Week 8 Week 8 - change from baseline	-0.1 PGA score Standard Deviation 0.9	-0.4 PGA score Standard Deviation 0.8	-0.2 PGA score Standard Deviation 0.8

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at Follow Up visit. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Descriptive Statistics - Week 16 (FU) Day 1	4.1 PGA score Standard Deviation 0.7	4.2 PGA score Standard Deviation 0.7	4.1 PGA score Standard Deviation 0.7
PGA Descriptive Statistics - Week 16 (FU) Week 16 (FU)	3.8 PGA score Standard Deviation 1.3	3.8 PGA score Standard Deviation 1.3	3.9 PGA score Standard Deviation 1.1
PGA Descriptive Statistics - Week 16 (FU) Week 16 (FU) - change from baseline	-0.2 PGA score Standard Deviation 1.1	-0.4 PGA score Standard Deviation 1.1	-0.1 PGA score Standard Deviation 0.7

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (baseline) is displayed.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Frequency Counts - Day 1 (Baseline) 0 - Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Day 1 (Baseline) 1 - Almost Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Day 1 (Baseline) 2 - Mild	1 Participants	0 Participants	0 Participants
PGA Frequency Counts - Day 1 (Baseline) 3 - Mild to Moderate	8 Participants	8 Participants	11 Participants
PGA Frequency Counts - Day 1 (Baseline) 4 - Moderate	28 Participants	24 Participants	27 Participants
PGA Frequency Counts - Day 1 (Baseline) 5 - Moderate to Severe	13 Participants	14 Participants	15 Participants
PGA Frequency Counts - Day 1 (Baseline) 6 - Severe	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Frequency Counts - Week 4 0 - Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Week 4 1 - Almost Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Week 4 2 - Mild	2 Participants	2 Participants	5 Participants
PGA Frequency Counts - Week 4 3 - Mild to Moderate	15 Participants	13 Participants	10 Participants
PGA Frequency Counts - Week 4 4 - Moderate	19 Participants	21 Participants	20 Participants
PGA Frequency Counts - Week 4 5 - Moderate to Severe	12 Participants	10 Participants	19 Participants
PGA Frequency Counts - Week 4 6 - Severe	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Frequency Counts - Week 8 0 - Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Week 8 1 - Almost Clear	0 Participants	1 Participants	1 Participants
PGA Frequency Counts - Week 8 2 - Mild	5 Participants	5 Participants	6 Participants
PGA Frequency Counts - Week 8 3 - Mild to Moderate	11 Participants	11 Participants	10 Participants
PGA Frequency Counts - Week 8 4 - Moderate	17 Participants	18 Participants	17 Participants
PGA Frequency Counts - Week 8 5 - Moderate to Severe	14 Participants	9 Participants	19 Participants
PGA Frequency Counts - Week 8 6 - Severe	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PGA Frequency Counts - Week 16 (FU) 0 - Clear	0 Participants	0 Participants	0 Participants
PGA Frequency Counts - Week 16 (FU) 1 - Almost Clear	2 Participants	3 Participants	1 Participants
PGA Frequency Counts - Week 16 (FU) 2 - Mild	4 Participants	4 Participants	4 Participants
PGA Frequency Counts - Week 16 (FU) 3 - Mild to Moderate	10 Participants	8 Participants	10 Participants
PGA Frequency Counts - Week 16 (FU) 4 - Moderate	9 Participants	11 Participants	14 Participants
PGA Frequency Counts - Week 16 (FU) 5 - Moderate to Severe	10 Participants	12 Participants	13 Participants
PGA Frequency Counts - Week 16 (FU) 6 - Severe	3 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
BSA Descriptive Statistics - Week 4 Day 1	19 percentage of body surface area Standard Deviation 8.8	19.2 percentage of body surface area Standard Deviation 10.5	17.5 percentage of body surface area Standard Deviation 6.3
BSA Descriptive Statistics - Week 4 Week 4	19.7 percentage of body surface area Standard Deviation 12.4	18.3 percentage of body surface area Standard Deviation 11.9	17.1 percentage of body surface area Standard Deviation 7.1
BSA Descriptive Statistics - Week 4 Week 4 - change from baseline	0.7 percentage of body surface area Standard Deviation 8.3	-0.9 percentage of body surface area Standard Deviation 6.3	-0.4 percentage of body surface area Standard Deviation 3.1

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=50 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=54 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
BSA Descriptive Statistics - Week 8 Day 1	19 percentage of body surface area Standard Deviation 8.8	19.2 percentage of body surface area Standard Deviation 10.5	17.5 percentage of body surface area Standard Deviation 6.3
BSA Descriptive Statistics - Week 8 Week 8	20.4 percentage of body surface area Standard Deviation 12.9	18.6 percentage of body surface area Standard Deviation 14.7	16.6 percentage of body surface area Standard Deviation 7.9
BSA Descriptive Statistics - Week 8 Week 8 - change from baseline	1.4 percentage of body surface area Standard Deviation 9.5	-0.6 percentage of body surface area Standard Deviation 9	-0.9 percentage of body surface area Standard Deviation 3.9

SECONDARY outcome

Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at follow up visit. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=38 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=40 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=44 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
BSA Descriptive Statistics - Week 16 (FU) Week 16 (FU)	20.9 BSA (%) Standard Deviation 15.5	20.2 BSA (%) Standard Deviation 19.8	15.5 BSA (%) Standard Deviation 6.4
BSA Descriptive Statistics - Week 16 (FU) Week 16 (FU) - change from baseline	0.6 BSA (%) Standard Deviation 12.8	0.4 BSA (%) Standard Deviation 13.4	-1.1 BSA (%) Standard Deviation 4.1

SECONDARY outcome

Timeframe: Morning dose on Study Day 1

Population: The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels.

The non-compartment parameter Cmax is the maximum MP1032 concentration observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=6 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=8 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PK Data - Cmax	388 Cmax (ng/mL) Standard Deviation 146.3	612.4 Cmax (ng/mL) Standard Deviation 467.3	—

SECONDARY outcome

Timeframe: Morning dose on Study Day 1

The non-compartment parameter tmax is the time point (effective) at which the maximum concentration (Cmax) was observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=6 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=8 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PK Data - Tmax	15 min Interval 13.0 to 30.0	22.5 min Interval 15.0 to 60.0	—

SECONDARY outcome

Timeframe: Morning dose on Study Day 1

The non-compartment parameter AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=6 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=8 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
PK Data - AUC(0,t)	15585.3 AUC(0,t) (ng/mL*min) Standard Deviation 5757.4	26543.8 AUC(0,t) (ng/mL*min) Standard Deviation 16592.3	—

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs	22 participants	15 participants	33 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with serious treatment emergent adverse events (TEAEs) in treatment groups compared to placebo

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With Serious TEAEs	0 participants	0 participants	3 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) leading to study discontinuation in treatment groups compared to placebo

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs Leading to Study Discontinuation	2 participants	0 participants	5 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by MedDRA System Organ Classes (SOCs). Only PTs (MedDRA Preferred Terms) occuring in at least 5% of the patients were considered for this overview.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs by SOC Infections and infestations	11 participants	8 participants	14 participants
Number of Patients With TEAEs by SOC Skin and subcutaneous tissue disorders	3 participants	4 participants	10 participants
Number of Patients With TEAEs by SOC Gastrointestinal disorder	5 participants	2 participants	7 participants
Number of Patients With TEAEs by SOC Nervous system disorder	2 participants	4 participants	2 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by severity

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs by Intensity Severe	2 participants	0 participants	4 participants
Number of Patients With TEAEs by Intensity Moderate	7 participants	4 participants	15 participants
Number of Patients With TEAEs by Intensity Mild	13 participants	11 participants	14 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs by Relation to the IMP Certainly related	0 participants	0 participants	0 participants
Number of Patients With TEAEs by Relation to the IMP Probably related	1 participants	0 participants	1 participants
Number of Patients With TEAEs by Relation to the IMP Possibly related	4 participants	2 participants	8 participants
Number of Patients With TEAEs by Relation to the IMP Unlikely related	6 participants	5 participants	14 participants
Number of Patients With TEAEs by Relation to the IMP Not related	11 participants	8 participants	10 participants

SECONDARY outcome

Timeframe: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment wherein "certainly", "probably" and "possibly related" were summarized as "related" whereas "unlikely" and "not related" were summarized as "not related".

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Number of Patients With TEAEs by Causality With the IMP Related	5 participants	2 participants	9 participants
Number of Patients With TEAEs by Causality With the IMP Not related	17 participants	13 participants	24 participants

SECONDARY outcome

Timeframe: overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Total (cumulative) number of dosed capsules = 6 \* # planned applications - # missed capsules + # overdose capsules. Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Extent of Exposure - Dosed Capsules	821.9 capsules Standard Deviation 304.3	920.6 capsules Standard Deviation 214.2	872.2 capsules Standard Deviation 248.3

SECONDARY outcome

Timeframe: overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Average number of capsules per application = # dosed capsules / # applications. Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Extent of Exposure - Capsules Per Application	6.00 capsules per application Standard Deviation 0.02	6.00 capsules per application Standard Deviation 0.01	6.00 capsules per application Standard Deviation 0

SECONDARY outcome

Timeframe: overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Average number of capsules per day = # dosed capsules / days of treatment. Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Extent of Exposure - Capsules Per Day	11.48 capsules per day Standard Deviation 1.40	11.85 capsules per day Standard Deviation 0.20	11.79 capsules per day Standard Deviation 0.20

SECONDARY outcome

Timeframe: overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Exposure was regarded as sufficient if the patient took at least 80% of planned applications (respectively capsules) wherein % exposure was calculated as 100 \* # dosed capsules / # planned capsules. Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks (i.e. 1008 capsules). The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=47 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Sufficient Extent of Exposure Insufficient	16 Participants	8 Participants	15 Participants
Sufficient Extent of Exposure Sufficient	35 Participants	39 Participants	40 Participants

SECONDARY outcome

Timeframe: overall trial / treatment period - cumulative from baseline to week 4, 8, 12 (EoT), and - if applicable - week16 (FU)

Population: The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Treatment duration = date of last dose - date of first dose + 1. 84 treatment days (12 weeks) were planned.

Outcome measures

Outcome measures
Measure	150 mg MP1032 Bid n=51 Participants 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 Participants 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 Participants 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient
Extent of Exposure - Treatment Duration	70.7 days Standard Deviation 24.1	76.1 days Standard Deviation 21.1	73.9 days Standard Deviation 21.0

Adverse Events

150 mg MP1032 Bid

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

300 mg MP1032 Bid

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo Bid

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Screening / Pre-Treatment

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	150 mg MP1032 Bid n=51 participants at risk 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient Placebo: hard gelatin capsules containing no active ingredient	300 mg MP1032 Bid n=48 participants at risk 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. MP1032: hard gelatin capsules containing 50mg MP1032 as active ingredient	Placebo Bid n=55 participants at risk 6 × placebo hard gelatin capsules (per dosage) provided twice daily over a period of 12 weeks. Placebo: hard gelatin capsules containing no active ingredient	Screening / Pre-Treatment n=204 participants at risk This section includes all (non-treatment emergent) AEs that occured either in the screening phase (up to 28 days, overall 204 patients from whom eventually 155 patients were randomized to any of the intervention groups) or after randomization but before any IMP was administrated.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/51 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/48 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	1.8% 1/55 • Number of events 1 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/204 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).
Skin and subcutaneous tissue disorders Malum perforans	0.00% 0/51 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/48 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	1.8% 1/55 • Number of events 1 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/204 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/51 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/48 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	1.8% 1/55 • Number of events 1 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/204 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).
Cardiac disorders Acute myocardial infarction	0.00% 0/51 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/48 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.00% 0/55 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).	0.49% 1/204 • Number of events 1 • Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), and Week 16 (Follow Up). Additionally participants were encouraged to report AEs anytime between the visits. Only treatment-emergent AEs (TEAEs), i.e. AEs occuring after at least one dose of trial medication was administered, are listed in the investigational groups. All non treatment emergent AEs are listed in the screening/pretreatment column. AEs in the listing are described using the MedDRA Preferred Term (PT).

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