Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis (NCT03706209) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis
Germany155 participantsStarted 2018-02-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participants legally competent to sign and give informed consent.
✓. Adult male and female patients between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
✓. PASI score ≥10 - ≤20 at baseline
✓. BSA score: \> 10%
✓. Stable disease duration of ≥ 6 months at the initiation of IMP.
✓. topical therapy fails to control the disease
✓. Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
✓. 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):
Exclusion criteria
✕. 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.
✕. 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.
✕
What they're measuring
1
PASI 75 - Week 12 (EoT)
Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
2
PGA Improvement - Week 12 (EoT)
Timeframe: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
. 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.
✕. 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.
✕. Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
✕. Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
✕. Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
✕. 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.