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

A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Trial of Two Oral Doses (150 mg Bid / 300 mg Bid) of MP1032 in Male and Female Patients With Moderate-to-Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03706209

Enrollment

155

Registered

2018-10-15

Start date

2018-02-27

Completion date

2019-06-12

Last updated

2024-11-22

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

Conditions

Psoriasis

Keywords

moderate to severe, chronic, plaque psoriasis

Brief summary

The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis.

Detailed description

This trial is a randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) in adult patients with moderate-to-severe chronic plaque psoriasis. The trial design consists of a 28-day screening period, a 12-week treatment period, and subsequently a 28-day follow-up period. Each patient will have 6 visits and unscheduled visits as needed. Approximately 150 patients (2 × 50 patients MP1032 and 50 patients placebo) who meet the entry criteria will be randomized on Day 1 to receive either 150 mg MP1032, 300 mg MP1032 or placebo orally twice daily for 12 weeks. The administration of IMP will stop after end of study (in max. 13 weeks). PASI (Psoriasis Area and Severity Index), PGA (Physician Global Assessment) and BSA (Body Surface Area) Scores will be recorded at predefined timepoints as basis for the efficacy evaluation. Safety parameter will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit. To evaluate systemic concentrations of MP1032 PK (pharmacokinetics) samples will be analyzed in a subgroup.

Interventions

DRUGMP1032

hard gelatin capsules containing 50mg MP1032 as active ingredient

DRUGPlacebo

hard gelatin capsules containing no active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blind

Intervention model description

Three-arm randomized, double-blind, placebo-controlled, parallel group phase II multi-center trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Participants legally competent to sign and give informed consent. 2. Adult male and female patients between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator): 1. PASI score ≥10 - ≤20 at baseline 2. BSA score: \> 10% 3. Stable disease duration of ≥ 6 months at the initiation of IMP. 4. topical therapy fails to control the disease 3. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2. 4. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception): 1. A method with less than 1% failure rate OR 2. Abstinence 5. Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition) 6. Male patients who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index \< 1%) would be to use implants, injectable, combined oral contraceptives, some intrauterine devices, or be postmenopausal, be surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) 7. In good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology and urinalysis 8. Patients must meet the following clinical laboratory criteria: * White blood cell count ≥3.5 × 109/L * Platelet count ≥100 × 109/L * Serum creatinine ≤1.5 × upper limit of normal (ULN); estimated glomerular filtration rate \>60 mL/min * Total bilirubin ≤1.5 × ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN * Hemoglobin ≥ lower limit of normal as per central laboratory reference ranges for women and men accordingly * No coagulopathy (International Normalized Ratio \[INR\] \<1.5) 9. Patients agree to minimize normal sun exposure during the course of the trial 10. Patients are considered reliable and capable of adhering to the protocol (e.g. able to understand the patient information and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.

Exclusion criteria

1. Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/

Design outcomes

Primary

Measure	Time frame	Description
PASI 75 - Week 12 (EoT)	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 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.
PGA Improvement - Week 12 (EoT)	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.

Secondary

Measure	Time frame	Description
PASI 50 - Week 12 (EoT)	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.
PASI ANCOVA Change From Baseline - Week 12 (EoT)	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.
PASI Descriptive Statistics - Week 12 (EoT)	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.
Time to PASI 75	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.
Time to PASI 50	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.
PGA Descriptive Statistics - Week 12 (EoT)	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.
PGA Frequency Counts - Week 12 (EoT)	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.
BSA Descriptive Statistics - Week 12 (EoT)	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 (%).
PASI 75 - Week 4	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 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 the respective visit (week 4) compared to baseline.
PASI 75 - Week 8	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 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 the respective visit (week 8) compared to baseline.
PASI 75 - Week 16 (FU)	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 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 the respective visit (Follow Up) compared to baseline.
PASI 50 - Week 4	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 the respective visit (week 4) compared to baseline.
PASI 50 - Week 8	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 the respective visit (week 8) compared to baseline.
PASI 50 - Week 16 (FU)	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 the respective visit (Follow Up) compared to baseline.
PASI ANCOVA Change From Baseline - Week 4	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.
PASI ANCOVA Change From Baseline - Week 8	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.
PASI ANCOVA Change From Baseline - Week 16 (FU)	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.
PASI Descriptive Statistics - Week 4	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.
PASI Descriptive Statistics - Week 8	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.
PASI Descriptive Statistics - Week 16 (FU)	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.
PGA Improvement - Week 4	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 the respective visit (week 4) compared to baseline.
PGA Improvement - Week 8	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 the respective visit (week 8) compared to baseline.
PGA Improvement - Week 16 (FU)	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 the respective visit (Follow Up) compared to baseline.
PGA Descriptive Statistics - Week 4	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).
PGA Descriptive Statistics - Week 8	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).
PGA Descriptive Statistics - Week 16 (FU)	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).
PGA Frequency Counts - Day 1 (Baseline)	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.
PGA Frequency Counts - Week 4	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 (week 4) is displayed.
PGA Frequency Counts - Week 8	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 (week 8) is displayed.
PGA Frequency Counts - Week 16 (FU)	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 follow up visit is displayed.
BSA Descriptive Statistics - Week 4	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 (%).
BSA Descriptive Statistics - Week 8	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 (%).
BSA Descriptive Statistics - Week 16 (FU)	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 (%).
PK Data - Cmax	Morning dose on Study Day 1	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.
PK Data - Tmax	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.
PK Data - AUC(0,t)	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.
Number of Patients With TEAEs	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo
Number of Patients With Serious TEAEs	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	Number of patients with serious treatment emergent adverse events (TEAEs) in treatment groups compared to placebo
Number of Patients With TEAEs Leading to Study Discontinuation	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	Number of patients with treatment emergent adverse events (TEAEs) leading to study discontinuation in treatment groups compared to placebo
Number of Patients With TEAEs by SOC	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	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.
Number of Patients With TEAEs by Intensity	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by severity
Number of Patients With TEAEs by Relation to the IMP	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment.
Number of Patients With TEAEs by Causality With the IMP	Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)	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.
PASI 75 VCS - Week 12 (EoT)	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 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.
Extent of Exposure - Capsules Per Application	overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)	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.
Extent of Exposure - Capsules Per Day	overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)	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.
Sufficient Extent of Exposure	overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)	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.
Extent of Exposure - Treatment Duration	overall trial / treatment period - cumulative from baseline to week 4, 8, 12 (EoT), and - if applicable - week16 (FU)	Treatment duration = date of last dose - date of first dose + 1. 84 treatment days (12 weeks) were planned.
Extent of Exposure - Dosed Capsules	overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)	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.
PGA Improvement VCS - Week 12 (EoT)	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.

Countries

Germany, Poland

Participant flow

Participants by arm

Arm	Count
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	51
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	48
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	55
Total	154

Baseline characteristics

Characteristic	150 mg MP1032 Bid	300 mg MP1032 Bid	Placebo Bid	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	2 Participants	3 Participants	8 Participants
Age, Categorical Between 18 and 65 years	48 Participants	46 Participants	52 Participants	146 Participants
Race/Ethnicity, Customized other	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White/Caucasian	51 Participants	48 Participants	55 Participants	154 Participants
Region of Enrollment Germany	12 Participants	14 Participants	15 Participants	41 Participants
Region of Enrollment Poland	39 Participants	34 Participants	40 Participants	113 Participants
Sex: Female, Male Female	10 Participants	18 Participants	20 Participants	48 Participants
Sex: Female, Male Male	41 Participants	30 Participants	35 Participants	106 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 51	0 / 48	0 / 55	0 / 204
other Total, other adverse events	22 / 51	15 / 48	32 / 55	7 / 204
serious Total, serious adverse events	0 / 51	0 / 48	3 / 55	1 / 204

Outcome results

Primary

PASI 75 - Week 12 (EoT)

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.

Time frame: 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.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 75 - Week 12 (EoT)	Responder	4 Participants
150 mg MP1032 Bid	PASI 75 - Week 12 (EoT)	Non-Responder	46 Participants
300 mg MP1032 Bid	PASI 75 - Week 12 (EoT)	Responder	4 Participants
300 mg MP1032 Bid	PASI 75 - Week 12 (EoT)	Non-Responder	43 Participants
Placebo Bid	PASI 75 - Week 12 (EoT)	Responder	1 Participants
Placebo Bid	PASI 75 - Week 12 (EoT)	Non-Responder	53 Participants

p-value: 0.16195% CI: [0.47, 35.97]Cochran-Mantel-Haenszel

p-value: 0.11195% CI: [0.55, 55.43]Cochran-Mantel-Haenszel

Primary

PGA Improvement - Week 12 (EoT)

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.

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Improvement - Week 12 (EoT)	Responder	14 Participants
150 mg MP1032 Bid	PGA Improvement - Week 12 (EoT)	Non-Responder	36 Participants
300 mg MP1032 Bid	PGA Improvement - Week 12 (EoT)	Responder	14 Participants
300 mg MP1032 Bid	PGA Improvement - Week 12 (EoT)	Non-Responder	33 Participants
Placebo Bid	PGA Improvement - Week 12 (EoT)	Responder	10 Participants
Placebo Bid	PGA Improvement - Week 12 (EoT)	Non-Responder	44 Participants

p-value: 0.22295% CI: [0.71, 4.25]Cochran-Mantel-Haenszel

p-value: 0.18295% CI: [0.75, 4.91]Cochran-Mantel-Haenszel

Secondary

BSA Descriptive Statistics - Week 12 (EoT)

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 (%).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	20.2 percentage of body surface area	Standard Deviation 13
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Day 1	19 percentage of body surface area	Standard Deviation 8.8
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	1.2 percentage of body surface area	Standard Deviation 9.4
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	19.7 percentage of body surface area	Standard Deviation 17.2
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Day 1	19.2 percentage of body surface area	Standard Deviation 10.5
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	0.5 percentage of body surface area	Standard Deviation 11.3
Placebo Bid	BSA Descriptive Statistics - Week 12 (EoT)	Day 1	17.5 percentage of body surface area	Standard Deviation 6.3
Placebo Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-0.2 percentage of body surface area	Standard Deviation 5.3
Placebo Bid	BSA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	17.3 percentage of body surface area	Standard Deviation 8.7

Secondary

BSA Descriptive Statistics - Week 16 (FU)

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 (%).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	20.9 BSA (%)	Standard Deviation 15.5
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	0.6 BSA (%)	Standard Deviation 12.8
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	20.2 BSA (%)	Standard Deviation 19.8
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	0.4 BSA (%)	Standard Deviation 13.4
Placebo Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	15.5 BSA (%)	Standard Deviation 6.4
Placebo Bid	BSA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-1.1 BSA (%)	Standard Deviation 4.1

Secondary

BSA Descriptive Statistics - Week 4

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 (%).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Week 4	19.7 percentage of body surface area	Standard Deviation 12.4
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Day 1	19 percentage of body surface area	Standard Deviation 8.8
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Week 4 - change from baseline	0.7 percentage of body surface area	Standard Deviation 8.3
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Week 4	18.3 percentage of body surface area	Standard Deviation 11.9
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Day 1	19.2 percentage of body surface area	Standard Deviation 10.5
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.9 percentage of body surface area	Standard Deviation 6.3
Placebo Bid	BSA Descriptive Statistics - Week 4	Day 1	17.5 percentage of body surface area	Standard Deviation 6.3
Placebo Bid	BSA Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.4 percentage of body surface area	Standard Deviation 3.1
Placebo Bid	BSA Descriptive Statistics - Week 4	Week 4	17.1 percentage of body surface area	Standard Deviation 7.1

Secondary

BSA Descriptive Statistics - Week 8

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 (%).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Week 8	20.4 percentage of body surface area	Standard Deviation 12.9
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Day 1	19 percentage of body surface area	Standard Deviation 8.8
150 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Week 8 - change from baseline	1.4 percentage of body surface area	Standard Deviation 9.5
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Week 8	18.6 percentage of body surface area	Standard Deviation 14.7
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Day 1	19.2 percentage of body surface area	Standard Deviation 10.5
300 mg MP1032 Bid	BSA Descriptive Statistics - Week 8	Week 8 - change from baseline	-0.6 percentage of body surface area	Standard Deviation 9
Placebo Bid	BSA Descriptive Statistics - Week 8	Day 1	17.5 percentage of body surface area	Standard Deviation 6.3
Placebo Bid	BSA Descriptive Statistics - Week 8	Week 8 - change from baseline	-0.9 percentage of body surface area	Standard Deviation 3.9
Placebo Bid	BSA Descriptive Statistics - Week 8	Week 8	16.6 percentage of body surface area	Standard Deviation 7.9

Secondary

Extent of Exposure - Capsules Per Application

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	Extent of Exposure - Capsules Per Application	6.00 capsules per application	Standard Deviation 0.02
300 mg MP1032 Bid	Extent of Exposure - Capsules Per Application	6.00 capsules per application	Standard Deviation 0.01
Placebo Bid	Extent of Exposure - Capsules Per Application	6.00 capsules per application	Standard Deviation 0

Secondary

Extent of Exposure - Capsules Per Day

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	Extent of Exposure - Capsules Per Day	11.48 capsules per day	Standard Deviation 1.4
300 mg MP1032 Bid	Extent of Exposure - Capsules Per Day	11.85 capsules per day	Standard Deviation 0.2
Placebo Bid	Extent of Exposure - Capsules Per Day	11.79 capsules per day	Standard Deviation 0.2

Secondary

Extent of Exposure - Dosed Capsules

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	Extent of Exposure - Dosed Capsules	821.9 capsules	Standard Deviation 304.3
300 mg MP1032 Bid	Extent of Exposure - Dosed Capsules	920.6 capsules	Standard Deviation 214.2
Placebo Bid	Extent of Exposure - Dosed Capsules	872.2 capsules	Standard Deviation 248.3

Secondary

Extent of Exposure - Treatment Duration

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

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	Extent of Exposure - Treatment Duration	70.7 days	Standard Deviation 24.1
300 mg MP1032 Bid	Extent of Exposure - Treatment Duration	76.1 days	Standard Deviation 21.1
Placebo Bid	Extent of Exposure - Treatment Duration	73.9 days	Standard Deviation 21

Secondary

Number of Patients With Serious TEAEs

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

Time frame: 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.

Arm	Measure	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With Serious TEAEs	0 participants
300 mg MP1032 Bid	Number of Patients With Serious TEAEs	0 participants
Placebo Bid	Number of Patients With Serious TEAEs	3 participants

p-value: 0.2439Fisher Exact

p-value: 0.2461Fisher Exact

Secondary

Number of Patients With TEAEs

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

Time frame: 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.

Arm	Measure	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs	22 participants
300 mg MP1032 Bid	Number of Patients With TEAEs	15 participants
Placebo Bid	Number of Patients With TEAEs	33 participants

p-value: 0.1193Fisher Exact

p-value: 0.0054Fisher Exact

Secondary

Number of Patients With TEAEs by Causality With the IMP

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs by Causality With the IMP	Related	5 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Causality With the IMP	Not related	17 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Causality With the IMP	Related	2 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Causality With the IMP	Not related	13 participants
Placebo Bid	Number of Patients With TEAEs by Causality With the IMP	Related	9 participants
Placebo Bid	Number of Patients With TEAEs by Causality With the IMP	Not related	24 participants

p-value: 0.098Fisher Exact

p-value: 0.0032Fisher Exact

Secondary

Number of Patients With TEAEs by Intensity

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Mild	13 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Moderate	7 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Severe	2 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Mild	11 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Severe	0 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Intensity	Moderate	4 participants
Placebo Bid	Number of Patients With TEAEs by Intensity	Moderate	15 participants
Placebo Bid	Number of Patients With TEAEs by Intensity	Severe	4 participants
Placebo Bid	Number of Patients With TEAEs by Intensity	Mild	14 participants

p-value: 0.0507Fisher Exact

p-value: 0.0005Fisher Exact

Secondary

Number of Patients With TEAEs by Relation to the IMP

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Unlikely related	6 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Possibly related	4 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Certainly related	0 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Probably related	1 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Not related	11 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Possibly related	2 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Certainly related	0 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Probably related	0 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Unlikely related	5 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by Relation to the IMP	Not related	8 participants
Placebo Bid	Number of Patients With TEAEs by Relation to the IMP	Not related	10 participants
Placebo Bid	Number of Patients With TEAEs by Relation to the IMP	Unlikely related	14 participants
Placebo Bid	Number of Patients With TEAEs by Relation to the IMP	Certainly related	0 participants
Placebo Bid	Number of Patients With TEAEs by Relation to the IMP	Possibly related	8 participants
Placebo Bid	Number of Patients With TEAEs by Relation to the IMP	Probably related	1 participants

p-value: 0.0504Fisher Exact

p-value: 0.0013Fisher Exact

Secondary

Number of Patients With TEAEs by SOC

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.

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Gastrointestinal disorder	5 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Nervous system disorder	2 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Skin and subcutaneous tissue disorders	3 participants
150 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Infections and infestations	11 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Infections and infestations	8 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Skin and subcutaneous tissue disorders	4 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Nervous system disorder	4 participants
300 mg MP1032 Bid	Number of Patients With TEAEs by SOC	Gastrointestinal disorder	2 participants
Placebo Bid	Number of Patients With TEAEs by SOC	Nervous system disorder	2 participants
Placebo Bid	Number of Patients With TEAEs by SOC	Infections and infestations	14 participants
Placebo Bid	Number of Patients With TEAEs by SOC	Skin and subcutaneous tissue disorders	10 participants
Placebo Bid	Number of Patients With TEAEs by SOC	Gastrointestinal disorder	7 participants

Secondary

Number of Patients With TEAEs Leading to Study Discontinuation

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

Time frame: 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.

Arm	Measure	Value (NUMBER)
150 mg MP1032 Bid	Number of Patients With TEAEs Leading to Study Discontinuation	2 participants
300 mg MP1032 Bid	Number of Patients With TEAEs Leading to Study Discontinuation	0 participants
Placebo Bid	Number of Patients With TEAEs Leading to Study Discontinuation	5 participants

p-value: 0.4395Fisher Exact

p-value: 0.0593Fisher Exact

Secondary

PASI 50 - Week 12 (EoT)

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.

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 50 - Week 12 (EoT)	Responder	8 Participants
150 mg MP1032 Bid	PASI 50 - Week 12 (EoT)	Non-Responder	42 Participants
300 mg MP1032 Bid	PASI 50 - Week 12 (EoT)	Responder	10 Participants
300 mg MP1032 Bid	PASI 50 - Week 12 (EoT)	Non-Responder	37 Participants
Placebo Bid	PASI 50 - Week 12 (EoT)	Non-Responder	48 Participants
Placebo Bid	PASI 50 - Week 12 (EoT)	Responder	6 Participants

p-value: 0.4795% CI: [0.5, 4.52]Cochran-Mantel-Haenszel

p-value: 0.13695% CI: [0.76, 7.82]Cochran-Mantel-Haenszel

Secondary

PASI 50 - Week 16 (FU)

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 50 - Week 16 (FU)	Responder	8 Participants
150 mg MP1032 Bid	PASI 50 - Week 16 (FU)	Non-Responder	30 Participants
300 mg MP1032 Bid	PASI 50 - Week 16 (FU)	Responder	10 Participants
300 mg MP1032 Bid	PASI 50 - Week 16 (FU)	Non-Responder	30 Participants
Placebo Bid	PASI 50 - Week 16 (FU)	Responder	6 Participants
Placebo Bid	PASI 50 - Week 16 (FU)	Non-Responder	38 Participants

p-value: 0.35595% CI: [0.53, 5.72]Cochran-Mantel-Haenszel

p-value: 0.19895% CI: [0.67, 7.37]Cochran-Mantel-Haenszel

Secondary

PASI 50 - Week 4

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 50 - Week 4	Responder	2 Participants
150 mg MP1032 Bid	PASI 50 - Week 4	Non-Responder	48 Participants
300 mg MP1032 Bid	PASI 50 - Week 4	Responder	7 Participants
300 mg MP1032 Bid	PASI 50 - Week 4	Non-Responder	40 Participants
Placebo Bid	PASI 50 - Week 4	Responder	5 Participants
Placebo Bid	PASI 50 - Week 4	Non-Responder	49 Participants

p-value: 0.28795% CI: [0.08, 2.27]Cochran-Mantel-Haenszel

p-value: 0.33295% CI: [0.53, 6.4]Cochran-Mantel-Haenszel

Secondary

PASI 50 - Week 8

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 50 - Week 8	Responder	5 Participants
150 mg MP1032 Bid	PASI 50 - Week 8	Non-Responder	45 Participants
300 mg MP1032 Bid	PASI 50 - Week 8	Responder	9 Participants
300 mg MP1032 Bid	PASI 50 - Week 8	Non-Responder	38 Participants
Placebo Bid	PASI 50 - Week 8	Responder	7 Participants
Placebo Bid	PASI 50 - Week 8	Non-Responder	47 Participants

p-value: 0.71995% CI: [0.25, 2.63]Cochran-Mantel-Haenszel

p-value: 0.35795% CI: [0.55, 5.32]Cochran-Mantel-Haenszel

Secondary

PASI 75 VCS - Week 12 (EoT)

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.

Time frame: 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.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 75 VCS - Week 12 (EoT)	Non-Responder	29 Participants
150 mg MP1032 Bid	PASI 75 VCS - Week 12 (EoT)	Responder	3 Participants
300 mg MP1032 Bid	PASI 75 VCS - Week 12 (EoT)	Responder	3 Participants
300 mg MP1032 Bid	PASI 75 VCS - Week 12 (EoT)	Non-Responder	33 Participants
Placebo Bid	PASI 75 VCS - Week 12 (EoT)	Non-Responder	33 Participants
Placebo Bid	PASI 75 VCS - Week 12 (EoT)	Responder	1 Participants

p-value: 0.29495% CI: [0.33, 25.39]Cochran-Mantel-Haenszel

p-value: 0.29195% CI: [0.31, 53.14]Cochran-Mantel-Haenszel

Secondary

PASI 75 - Week 16 (FU)

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 75 - Week 16 (FU)	Responder	4 Participants
150 mg MP1032 Bid	PASI 75 - Week 16 (FU)	Non-Responder	34 Participants
300 mg MP1032 Bid	PASI 75 - Week 16 (FU)	Responder	5 Participants
300 mg MP1032 Bid	PASI 75 - Week 16 (FU)	Non-Responder	35 Participants
Placebo Bid	PASI 75 - Week 16 (FU)	Responder	2 Participants
Placebo Bid	PASI 75 - Week 16 (FU)	Non-Responder	42 Participants

p-value: 0.37595% CI: [0.38, 12.84]Cochran-Mantel-Haenszel

p-value: 0.11695% CI: [0.66, 27.08]Cochran-Mantel-Haenszel

Secondary

PASI 75 - Week 4

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 75 - Week 4	Responder	0 Participants
150 mg MP1032 Bid	PASI 75 - Week 4	Non-Responder	50 Participants
300 mg MP1032 Bid	PASI 75 - Week 4	Responder	1 Participants
300 mg MP1032 Bid	PASI 75 - Week 4	Non-Responder	46 Participants
Placebo Bid	PASI 75 - Week 4	Responder	2 Participants
Placebo Bid	PASI 75 - Week 4	Non-Responder	52 Participants

p-value: 0.178Cochran-Mantel-Haenszel

p-value: 0.71895% CI: [0.05, 7.48]Cochran-Mantel-Haenszel

Secondary

PASI 75 - Week 8

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PASI 75 - Week 8	Responder	2 Participants
150 mg MP1032 Bid	PASI 75 - Week 8	Non-Responder	48 Participants
300 mg MP1032 Bid	PASI 75 - Week 8	Responder	1 Participants
300 mg MP1032 Bid	PASI 75 - Week 8	Non-Responder	46 Participants
Placebo Bid	PASI 75 - Week 8	Responder	1 Participants
Placebo Bid	PASI 75 - Week 8	Non-Responder	53 Participants

p-value: 0.47495% CI: [0.21, 28.05]Cochran-Mantel-Haenszel

p-value: 0.86795% CI: [0.08, 19.05]Cochran-Mantel-Haenszel

Secondary

PASI ANCOVA Change From Baseline - Week 12 (EoT)

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.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
150 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 12 (EoT)	0.1 score on a scale (PASI baseline change)	Standard Error 1
300 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 12 (EoT)	-1.1 score on a scale (PASI baseline change)	Standard Error 1
Placebo Bid	PASI ANCOVA Change From Baseline - Week 12 (EoT)	-0.1 score on a scale (PASI baseline change)	Standard Error 1

p-value: 0.89495% CI: [-2.6, 3]ANCOVA

Comparison: Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.p-value: 0.45695% CI: [-3.8, 1.7]ANCOVA

Secondary

PASI ANCOVA Change From Baseline - Week 16 (FU)

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.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
150 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 16 (FU)	-0.3 score on a scale (PASI baseline change)	Standard Error 1.3
300 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 16 (FU)	-0.8 score on a scale (PASI baseline change)	Standard Error 1.2
Placebo Bid	PASI ANCOVA Change From Baseline - Week 16 (FU)	-0.8 score on a scale (PASI baseline change)	Standard Error 1.2

Secondary

PASI ANCOVA Change From Baseline - Week 4

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.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
150 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 4	-0.3 score on a scale (PASI baseline change)	Standard Error 0.7
300 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 4	-1.7 score on a scale (PASI baseline change)	Standard Error 0.7
Placebo Bid	PASI ANCOVA Change From Baseline - Week 4	-0.6 score on a scale (PASI baseline change)	Standard Error 0.7

Secondary

PASI ANCOVA Change From Baseline - Week 8

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.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
150 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 8	0.2 score on a scale (PASI baseline change)	Standard Error 0.9
300 mg MP1032 Bid	PASI ANCOVA Change From Baseline - Week 8	-1.8 score on a scale (PASI baseline change)	Standard Error 0.9
Placebo Bid	PASI ANCOVA Change From Baseline - Week 8	-0.8 score on a scale (PASI baseline change)	Standard Error 0.8

Secondary

PASI Descriptive Statistics - Week 12 (EoT)

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	15 score on a scale (PASI)	Standard Deviation 9.1
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Day 1	14.7 score on a scale (PASI)	Standard Deviation 2.8
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	0.3 score on a scale (PASI)	Standard Deviation 8.4
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	13 score on a scale (PASI)	Standard Deviation 9
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Day 1	14.2 score on a scale (PASI)	Standard Deviation 2.7
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-1.2 score on a scale (PASI)	Standard Deviation 7.6
Placebo Bid	PASI Descriptive Statistics - Week 12 (EoT)	Day 1	13.8 score on a scale (PASI)	Standard Deviation 2.5
Placebo Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-0.3 score on a scale (PASI)	Standard Deviation 5.5
Placebo Bid	PASI Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	13.5 score on a scale (PASI)	Standard Deviation 6

Secondary

PASI Descriptive Statistics - Week 16 (FU)

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	15.1 score on a scale (PASI)	Standard Deviation 9.3
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	0.3 score on a scale (PASI)	Standard Deviation 9
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-0.7 score on a scale (PASI)	Standard Deviation 9.6
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	13.6 score on a scale (PASI)	Standard Deviation 11
Placebo Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	12.3 score on a scale (PASI)	Standard Deviation 5.1
Placebo Bid	PASI Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-1.2 score on a scale (PASI)	Standard Deviation 4.7

Secondary

PASI Descriptive Statistics - Week 4

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Week 4	14.5 score on a scale (PASI)	Standard Deviation 7.1
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Day 1	14.7 score on a scale (PASI)	Standard Deviation 2.8
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.2 score on a scale (PASI)	Standard Deviation 6.3
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Week 4	12.4 score on a scale (PASI)	Standard Deviation 5.5
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Day 1	14.2 score on a scale (PASI)	Standard Deviation 2.7
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 4	Week 4 - change from baseline	-1.8 score on a scale (PASI)	Standard Deviation 4.2
Placebo Bid	PASI Descriptive Statistics - Week 4	Day 1	13.8 score on a scale (PASI)	Standard Deviation 2.5
Placebo Bid	PASI Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.7 score on a scale (PASI)	Standard Deviation 4.1
Placebo Bid	PASI Descriptive Statistics - Week 4	Week 4	13.1 score on a scale (PASI)	Standard Deviation 4.6

Secondary

PASI Descriptive Statistics - Week 8

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Week 8	15.1 score on a scale (PASI)	Standard Deviation 8.1
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Day 1	14.7 score on a scale (PASI)	Standard Deviation 2.8
150 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Week 8 - change from baseline	0.4 score on a scale (PASI)	Standard Deviation 7.4
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Week 8	12.3 score on a scale (PASI)	Standard Deviation 7.8
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Day 1	14.2 score on a scale (PASI)	Standard Deviation 2.7
300 mg MP1032 Bid	PASI Descriptive Statistics - Week 8	Week 8 - change from baseline	-1.9 score on a scale (PASI)	Standard Deviation 6.4
Placebo Bid	PASI Descriptive Statistics - Week 8	Day 1	13.8 score on a scale (PASI)	Standard Deviation 2.5
Placebo Bid	PASI Descriptive Statistics - Week 8	Week 8 - change from baseline	-1 score on a scale (PASI)	Standard Deviation 4.9
Placebo Bid	PASI Descriptive Statistics - Week 8	Week 8	12.8 score on a scale (PASI)	Standard Deviation 5.4

Secondary

PGA Descriptive Statistics - Week 12 (EoT)

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	4.0 score on a scale (PGA)	Standard Deviation 1.3
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Day 1	4.1 score on a scale (PGA)	Standard Deviation 0.7
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-0.1 score on a scale (PGA)	Standard Deviation 1.1
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	3.8 score on a scale (PGA)	Standard Deviation 1.2
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Day 1	4.2 score on a scale (PGA)	Standard Deviation 0.7
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-0.4 score on a scale (PGA)	Standard Deviation 1
Placebo Bid	PGA Descriptive Statistics - Week 12 (EoT)	Day 1	4.1 score on a scale (PGA)	Standard Deviation 0.7
Placebo Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT) - change from baseline	-0.0 score on a scale (PGA)	Standard Deviation 0.8
Placebo Bid	PGA Descriptive Statistics - Week 12 (EoT)	Week 12 (EoT)	4.1 score on a scale (PGA)	Standard Deviation 1

p-value: 0.99295% CI: [0, 0]Wilcoxon (Mann-Whitney)

p-value: 0.14395% CI: [0, 0]Wilcoxon (Mann-Whitney)

Secondary

PGA Descriptive Statistics - Week 16 (FU)

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).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	3.8 PGA score	Standard Deviation 1.3
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Day 1	4.1 PGA score	Standard Deviation 0.7
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-0.2 PGA score	Standard Deviation 1.1
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	3.8 PGA score	Standard Deviation 1.3
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Day 1	4.2 PGA score	Standard Deviation 0.7
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-0.4 PGA score	Standard Deviation 1.1
Placebo Bid	PGA Descriptive Statistics - Week 16 (FU)	Day 1	4.1 PGA score	Standard Deviation 0.7
Placebo Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU) - change from baseline	-0.1 PGA score	Standard Deviation 0.7
Placebo Bid	PGA Descriptive Statistics - Week 16 (FU)	Week 16 (FU)	3.9 PGA score	Standard Deviation 1.1

p-value: 0.92195% CI: [0, 0]Wilcoxon (Mann-Whitney)

p-value: 0.48895% CI: [0, 0]Wilcoxon (Mann-Whitney)

Secondary

PGA Descriptive Statistics - Week 4

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).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Week 4	3.9 PGA score	Standard Deviation 0.9
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Day 1	4.1 PGA score	Standard Deviation 0.7
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.1 PGA score	Standard Deviation 0.7
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Week 4	3.9 PGA score	Standard Deviation 0.9
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Day 1	4.2 PGA score	Standard Deviation 0.7
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.3 PGA score	Standard Deviation 0.6
Placebo Bid	PGA Descriptive Statistics - Week 4	Day 1	4.1 PGA score	Standard Deviation 0.7
Placebo Bid	PGA Descriptive Statistics - Week 4	Week 4 - change from baseline	-0.1 PGA score	Standard Deviation 0.6
Placebo Bid	PGA Descriptive Statistics - Week 4	Week 4	4.0 PGA score	Standard Deviation 1

p-value: 0.67195% CI: [0, 0]Wilcoxon (Mann-Whitney)

p-value: 0.18395% CI: [0, 0]Wilcoxon (Mann-Whitney)

Secondary

PGA Descriptive Statistics - Week 8

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).

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

Arm	Measure	Group	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Week 8	4.0 PGA score	Standard Deviation 1.1
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Day 1	4.1 PGA score	Standard Deviation 0.7
150 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Week 8 - change from baseline	-0.1 PGA score	Standard Deviation 0.9
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Week 8	3.8 PGA score	Standard Deviation 1.1
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Day 1	4.2 PGA score	Standard Deviation 0.7
300 mg MP1032 Bid	PGA Descriptive Statistics - Week 8	Week 8 - change from baseline	-0.4 PGA score	Standard Deviation 0.8
Placebo Bid	PGA Descriptive Statistics - Week 8	Day 1	4.1 PGA score	Standard Deviation 0.7
Placebo Bid	PGA Descriptive Statistics - Week 8	Week 8 - change from baseline	-0.2 PGA score	Standard Deviation 0.8
Placebo Bid	PGA Descriptive Statistics - Week 8	Week 8	3.9 PGA score	Standard Deviation 1.1

p-value: 0.54295% CI: [0, 0]Wilcoxon (Mann-Whitney)

p-value: 0.32895% CI: [0, 0]Wilcoxon (Mann-Whitney)

Secondary

PGA Frequency Counts - Day 1 (Baseline)

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.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	1 - Almost Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	5 - Moderate to Severe	13 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	3 - Mild to Moderate	8 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	0 - Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	4 - Moderate	28 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	6 - Severe	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	2 - Mild	1 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	5 - Moderate to Severe	14 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	0 - Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	1 - Almost Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	2 - Mild	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	3 - Mild to Moderate	8 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	4 - Moderate	24 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Day 1 (Baseline)	6 - Severe	1 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	4 - Moderate	27 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	2 - Mild	0 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	5 - Moderate to Severe	15 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	1 - Almost Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	0 - Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	3 - Mild to Moderate	11 Participants
Placebo Bid	PGA Frequency Counts - Day 1 (Baseline)	6 - Severe	1 Participants

Secondary

PGA Frequency Counts - Week 12 (EoT)

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.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	0 - Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	3 - Mild to Moderate	10 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	4 - Moderate	15 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	5 - Moderate to Severe	12 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	6 - Severe	6 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	1 - Almost Clear	1 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	2 - Mild	6 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	6 - Severe	2 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	2 - Mild	7 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	3 - Mild to Moderate	9 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	5 - Moderate to Severe	13 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	1 - Almost Clear	1 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	4 - Moderate	15 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 12 (EoT)	0 - Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	4 - Moderate	18 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	5 - Moderate to Severe	18 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	2 - Mild	4 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	6 - Severe	3 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	0 - Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	3 - Mild to Moderate	11 Participants
Placebo Bid	PGA Frequency Counts - Week 12 (EoT)	1 - Almost Clear	0 Participants

Secondary

PGA Frequency Counts - Week 16 (FU)

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	2 - Mild	4 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	6 - Severe	3 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	4 - Moderate	9 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	3 - Mild to Moderate	10 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	1 - Almost Clear	2 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	0 - Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	5 - Moderate to Severe	10 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	5 - Moderate to Severe	12 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	0 - Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	1 - Almost Clear	3 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	2 - Mild	4 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	3 - Mild to Moderate	8 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	4 - Moderate	11 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 16 (FU)	6 - Severe	2 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	6 - Severe	2 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	4 - Moderate	14 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	1 - Almost Clear	1 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	5 - Moderate to Severe	13 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	0 - Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	3 - Mild to Moderate	10 Participants
Placebo Bid	PGA Frequency Counts - Week 16 (FU)	2 - Mild	4 Participants

Secondary

PGA Frequency Counts - Week 4

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	1 - Almost Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	4 - Moderate	19 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	3 - Mild to Moderate	15 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	0 - Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	6 - Severe	2 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	5 - Moderate to Severe	12 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 4	2 - Mild	2 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	3 - Mild to Moderate	13 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	0 - Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	1 - Almost Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	2 - Mild	2 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	4 - Moderate	21 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	5 - Moderate to Severe	10 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 4	6 - Severe	1 Participants
Placebo Bid	PGA Frequency Counts - Week 4	4 - Moderate	20 Participants
Placebo Bid	PGA Frequency Counts - Week 4	1 - Almost Clear	0 Participants
Placebo Bid	PGA Frequency Counts - Week 4	6 - Severe	0 Participants
Placebo Bid	PGA Frequency Counts - Week 4	5 - Moderate to Severe	19 Participants
Placebo Bid	PGA Frequency Counts - Week 4	3 - Mild to Moderate	10 Participants
Placebo Bid	PGA Frequency Counts - Week 4	2 - Mild	5 Participants
Placebo Bid	PGA Frequency Counts - Week 4	0 - Clear	0 Participants

Secondary

PGA Frequency Counts - Week 8

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	1 - Almost Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	4 - Moderate	17 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	3 - Mild to Moderate	11 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	0 - Clear	0 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	6 - Severe	3 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	5 - Moderate to Severe	14 Participants
150 mg MP1032 Bid	PGA Frequency Counts - Week 8	2 - Mild	5 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	3 - Mild to Moderate	11 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	0 - Clear	0 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	1 - Almost Clear	1 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	2 - Mild	5 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	4 - Moderate	18 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	5 - Moderate to Severe	9 Participants
300 mg MP1032 Bid	PGA Frequency Counts - Week 8	6 - Severe	3 Participants
Placebo Bid	PGA Frequency Counts - Week 8	4 - Moderate	17 Participants
Placebo Bid	PGA Frequency Counts - Week 8	1 - Almost Clear	1 Participants
Placebo Bid	PGA Frequency Counts - Week 8	6 - Severe	1 Participants
Placebo Bid	PGA Frequency Counts - Week 8	5 - Moderate to Severe	19 Participants
Placebo Bid	PGA Frequency Counts - Week 8	3 - Mild to Moderate	10 Participants
Placebo Bid	PGA Frequency Counts - Week 8	2 - Mild	6 Participants
Placebo Bid	PGA Frequency Counts - Week 8	0 - Clear	0 Participants

Secondary

PGA Improvement VCS - Week 12 (EoT)

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.

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Improvement VCS - Week 12 (EoT)	Responder	9 Participants
150 mg MP1032 Bid	PGA Improvement VCS - Week 12 (EoT)	Non-Responder	23 Participants
300 mg MP1032 Bid	PGA Improvement VCS - Week 12 (EoT)	Responder	13 Participants
300 mg MP1032 Bid	PGA Improvement VCS - Week 12 (EoT)	Non-Responder	23 Participants
Placebo Bid	PGA Improvement VCS - Week 12 (EoT)	Responder	8 Participants
Placebo Bid	PGA Improvement VCS - Week 12 (EoT)	Non-Responder	26 Participants

p-value: 0.61795% CI: [0.45, 3.77]Cochran-Mantel-Haenszel

p-value: 0.31995% CI: [0.6, 5]Cochran-Mantel-Haenszel

Secondary

PGA Improvement - Week 16 (FU)

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Improvement - Week 16 (FU)	Responder	14 Participants
150 mg MP1032 Bid	PGA Improvement - Week 16 (FU)	Non-Responder	24 Participants
300 mg MP1032 Bid	PGA Improvement - Week 16 (FU)	Responder	13 Participants
300 mg MP1032 Bid	PGA Improvement - Week 16 (FU)	Non-Responder	27 Participants
Placebo Bid	PGA Improvement - Week 16 (FU)	Responder	12 Participants
Placebo Bid	PGA Improvement - Week 16 (FU)	Non-Responder	32 Participants

p-value: 0.31195% CI: [0.63, 4.26]Cochran-Mantel-Haenszel

p-value: 0.69995% CI: [0.47, 3.17]Cochran-Mantel-Haenszel

Secondary

PGA Improvement - Week 4

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Improvement - Week 4	Responder	11 Participants
150 mg MP1032 Bid	PGA Improvement - Week 4	Non-Responder	39 Participants
300 mg MP1032 Bid	PGA Improvement - Week 4	Responder	13 Participants
300 mg MP1032 Bid	PGA Improvement - Week 4	Non-Responder	34 Participants
Placebo Bid	PGA Improvement - Week 4	Responder	9 Participants
Placebo Bid	PGA Improvement - Week 4	Non-Responder	45 Participants

p-value: 0.4595% CI: [0.55, 3.8]Cochran-Mantel-Haenszel

p-value: 0.18695% CI: [0.74, 5.26]Cochran-Mantel-Haenszel

Secondary

PGA Improvement - Week 8

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	PGA Improvement - Week 8	Responder	12 Participants
150 mg MP1032 Bid	PGA Improvement - Week 8	Non-Responder	38 Participants
300 mg MP1032 Bid	PGA Improvement - Week 8	Responder	16 Participants
300 mg MP1032 Bid	PGA Improvement - Week 8	Non-Responder	31 Participants
Placebo Bid	PGA Improvement - Week 8	Responder	14 Participants
Placebo Bid	PGA Improvement - Week 8	Non-Responder	40 Participants

p-value: 0.88495% CI: [0.41, 2.18]Cochran-Mantel-Haenszel

p-value: 0.38495% CI: [0.61, 3.64]Cochran-Mantel-Haenszel

Secondary

PK Data - AUC(0,t)

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PK Data - AUC(0,t)	15585.3 AUC(0,t) (ng/mL*min)	Standard Deviation 5757.4
300 mg MP1032 Bid	PK Data - AUC(0,t)	26543.8 AUC(0,t) (ng/mL*min)	Standard Deviation 16592.3

Secondary

PK Data - Cmax

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.

Time frame: Morning dose on Study Day 1

Arm	Measure	Value (MEAN)	Dispersion
150 mg MP1032 Bid	PK Data - Cmax	388 Cmax (ng/mL)	Standard Deviation 146.3
300 mg MP1032 Bid	PK Data - Cmax	612.4 Cmax (ng/mL)	Standard Deviation 467.3

Secondary

PK Data - Tmax

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.

Time frame: Morning dose on Study Day 1

Arm	Measure	Value (MEDIAN)
150 mg MP1032 Bid	PK Data - Tmax	15 min
300 mg MP1032 Bid	PK Data - Tmax	22.5 min

Secondary

Sufficient Extent of Exposure

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	Sufficient Extent of Exposure	Insufficient	16 Participants
150 mg MP1032 Bid	Sufficient Extent of Exposure	Sufficient	35 Participants
300 mg MP1032 Bid	Sufficient Extent of Exposure	Insufficient	8 Participants
300 mg MP1032 Bid	Sufficient Extent of Exposure	Sufficient	39 Participants
Placebo Bid	Sufficient Extent of Exposure	Insufficient	15 Participants
Placebo Bid	Sufficient Extent of Exposure	Sufficient	40 Participants

Secondary

Time to PASI 50

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.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	Time to PASI 50	Week 4	2 Participants
150 mg MP1032 Bid	Time to PASI 50	Week 8	4 Participants
150 mg MP1032 Bid	Time to PASI 50	Week 12 (EoT)	4 Participants
150 mg MP1032 Bid	Time to PASI 50	Week 16 (FU)	1 Participants
300 mg MP1032 Bid	Time to PASI 50	Week 16 (FU)	3 Participants
300 mg MP1032 Bid	Time to PASI 50	Week 4	7 Participants
300 mg MP1032 Bid	Time to PASI 50	Week 12 (EoT)	3 Participants
300 mg MP1032 Bid	Time to PASI 50	Week 8	3 Participants
Placebo Bid	Time to PASI 50	Week 16 (FU)	2 Participants
Placebo Bid	Time to PASI 50	Week 8	2 Participants
Placebo Bid	Time to PASI 50	Week 12 (EoT)	2 Participants
Placebo Bid	Time to PASI 50	Week 4	5 Participants

p-value: 0.7922Log Rank

p-value: 0.1425Log Rank

Secondary

Time to PASI 75

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.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
150 mg MP1032 Bid	Time to PASI 75	Week 12 (EoT)	3 Participants
150 mg MP1032 Bid	Time to PASI 75	Week 4	0 Participants
150 mg MP1032 Bid	Time to PASI 75	Week 8	2 Participants
150 mg MP1032 Bid	Time to PASI 75	Week 16 (FU)	0 Participants
300 mg MP1032 Bid	Time to PASI 75	Week 4	1 Participants
300 mg MP1032 Bid	Time to PASI 75	Week 8	0 Participants
300 mg MP1032 Bid	Time to PASI 75	Week 12 (EoT)	3 Participants
300 mg MP1032 Bid	Time to PASI 75	Week 16 (FU)	2 Participants
Placebo Bid	Time to PASI 75	Week 12 (EoT)	1 Participants
Placebo Bid	Time to PASI 75	Week 4	2 Participants
Placebo Bid	Time to PASI 75	Week 8	0 Participants
Placebo Bid	Time to PASI 75	Week 16 (FU)	1 Participants

p-value: 0.572Log Rank

p-value: 0.4494Log Rank

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

PASI 75 - Week 12 (EoT)

PGA Improvement - Week 12 (EoT)

BSA Descriptive Statistics - Week 12 (EoT)

BSA Descriptive Statistics - Week 16 (FU)

BSA Descriptive Statistics - Week 4

BSA Descriptive Statistics - Week 8

Extent of Exposure - Capsules Per Application

Extent of Exposure - Capsules Per Day

Extent of Exposure - Dosed Capsules

Extent of Exposure - Treatment Duration

Number of Patients With Serious TEAEs

Number of Patients With TEAEs

Number of Patients With TEAEs by Causality With the IMP

Number of Patients With TEAEs by Intensity

Number of Patients With TEAEs by Relation to the IMP

Number of Patients With TEAEs by SOC

Number of Patients With TEAEs Leading to Study Discontinuation

PASI 50 - Week 12 (EoT)

PASI 50 - Week 16 (FU)

PASI 50 - Week 4

PASI 50 - Week 8

PASI 75 VCS - Week 12 (EoT)

PASI 75 - Week 16 (FU)

PASI 75 - Week 4

PASI 75 - Week 8

PASI ANCOVA Change From Baseline - Week 12 (EoT)

PASI ANCOVA Change From Baseline - Week 16 (FU)

PASI ANCOVA Change From Baseline - Week 4

PASI ANCOVA Change From Baseline - Week 8

PASI Descriptive Statistics - Week 12 (EoT)

PASI Descriptive Statistics - Week 16 (FU)

PASI Descriptive Statistics - Week 4

PASI Descriptive Statistics - Week 8

PGA Descriptive Statistics - Week 12 (EoT)

PGA Descriptive Statistics - Week 16 (FU)

PGA Descriptive Statistics - Week 4

PGA Descriptive Statistics - Week 8

PGA Frequency Counts - Day 1 (Baseline)

PGA Frequency Counts - Week 12 (EoT)

PGA Frequency Counts - Week 16 (FU)

PGA Frequency Counts - Week 4

PGA Frequency Counts - Week 8

PGA Improvement VCS - Week 12 (EoT)

PGA Improvement - Week 16 (FU)

PGA Improvement - Week 4

PGA Improvement - Week 8

PK Data - AUC(0,t)

PK Data - Cmax

PK Data - Tmax

Sufficient Extent of Exposure

Time to PASI 50

Time to PASI 75