NCT03706209

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: MetrioPharm AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	MP1032	hard gelatin capsules containing 50mg MP1032 as active ingredient
DRUG	Placebo	hard gelatin capsules containing no active ingredient

Timeline

• Start date: 2018-02-27
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2018-10-15
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

19 sites across 2 countries: Germany, Poland