MedPath

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

Phase 2
Completed
Conditions
Psoriasis
Interventions
Drug: Placebo
Registration Number
NCT03706209
Lead Sponsor
MetrioPharm AG
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
155
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-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well -being of the patient and there is no impact on trial objectives as determined by the Investigator.
  2. Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE (angiotensin-converting-enzyme) inhibitors unless on a stable dose for 3 months before IMP intake.
  3. Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis.
  4. Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator.
  5. Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
  6. Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
  7. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
  8. History or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the patient at risk by trial participation or influence the outcome of the trial. Well controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism are permitted.
  9. Patients with active malignancy or history of malignancy, except for basal cell and actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that have been fully treated and show no evidence of recurrence are allowed.
  10. Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.
  11. Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP initiation.
  12. Known photo allergy and / or experienced drug-induced photo toxicity.
  13. Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
  14. Prior treatment not adhering to defined drug classes and related washout periods (Protocol table 2.)
  15. Planned use of any ultraviolet (UV) phototherapy or photochemotherapy / photosensitizing drugs during the course of the trial and within 28 days/24 weeks following the last dose of the IMP.
  16. Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation.
  17. Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95 mm Hg (diastolic)
  18. Patients who are employed by MetrioPharm, contract research organization (CRO) or clinical site involved in the clinical trial.
  19. Vulnerable patients (e.g. patients kept in detention).
  20. Patients who are unable to communicate, read or understand the local language, or who display another condition, which, in the Investigator's opinion, makes them unsuitable for clinical trial participation.
  21. Patient is institutionalized because of legal or regulatory order.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
150 mg MP1032 bidMP10323 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.
150 mg MP1032 bidPlacebo3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.
Placebo bidPlacebo6 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.
300 mg MP1032 bidMP10326 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

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.

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 75from 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 50from 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 4Scoring 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 8Scoring 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 4Scoring 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 8Scoring 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 4Scoring 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 8Scoring 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.

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.

PASI Descriptive Statistics - Week 4Scoring 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 8Scoring 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 4Scoring 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 8Scoring 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 4Scoring 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 8Scoring 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 4Scoring 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 8Scoring 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.

BSA Descriptive Statistics - Week 4Scoring 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 8Scoring 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 - CmaxMorning 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 - TmaxMorning 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 TEAEsOverall 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 TEAEsOverall 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 DiscontinuationOverall 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 SOCOverall 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 IntensityOverall 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 IMPOverall 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 IMPOverall 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".

Extent of Exposure - Dosed Capsulesoverall 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.

Extent of Exposure - Capsules Per Applicationoverall 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 Dayoverall 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 Exposureoverall 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 Durationoverall 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.

Trial Locations

Locations (19)

Klinische Forschung Dresden GmbH

🇩🇪

Dresden, Germany

Kliniczny Szpital Wojewódzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii

🇵🇱

Rzeszów, Poland

MensingDerma

🇩🇪

Hamburg, Germany

DermMEDICA Sp. z o.o.

🇵🇱

Wrocław, Poland

Provita Sp. z o.o., Centrum Medyczne Angelius Provita

🇵🇱

Katowice, Poland

Klinische Forschung Schwerin (kfsn)

🇩🇪

Schwerin, Germany

Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

🇵🇱

Łódź, Poland

MULTIKLINIKA SALUTE Sp. z o. o.

🇵🇱

Katowice, Poland

Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski

🇵🇱

Szczecin, Poland

Dr. Tsianakas / Dr. Ameluxen

🇩🇪

Bad Bentheim, Germany

Rothaar Studien GmbH

🇩🇪

Berlin, Germany

Dr. Johannes Niesmann / Dr. Othlinghaus

🇩🇪

Bochum, Germany

Hautarztpraxis Dres. med. Scholz, Sebastian, Schilling

🇩🇪

Mahlow, Germany

MVZ DermaKiel

🇩🇪

Kiel, Germany

Universitätsmedizin Mainz, Hautklinik und Poliklinik

🇩🇪

Mainz, Germany

Centroderm GmbH

🇩🇪

Wuppertal, Germany

GynCentrum Sp. Z o.o.

🇵🇱

Katowice, Poland

CENTRUM MEDYCZNE PLEJADY Sp. z o. o. spółka komandytowa

🇵🇱

Kraków, Poland

Dermedic Jacek Zdybski

🇵🇱

Ostrowiec Świętokrzyski, Poland

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Posted 10/18/2010
Updated 11/18/2016
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