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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03706209
Study type Interventional
Source MetrioPharm AG
Contact
Status Completed
Phase Phase 2
Start date February 27, 2018
Completion date June 12, 2019

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