Psoriasis Clinical Trial
Official title:
A Randomized (1:1), Double-blind, Parallel, Placebo-controlled Exploratory Pilot Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Systemic (po) Application of MP1032 in Patients With Moderate to Severe Chronic Plaque Psoriasis
This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of
oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary
endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period
and a 4-week follow up will provide an opportunity to perform a first assessment of oral
MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.
The study population will consist of 44 enrolled (40 completed) patients with moderate to
severe chronic plaque psoriasis. Patients must be able to provide written consent and meet
all the inclusion criteria and none of the exclusion criteria.
This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot
study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration
of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.
The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1
day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who
meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg
MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each
treatment group) complete the study.
Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from
the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.
Efficacy will be assessed on 6 designated study days using the following assessments: PASI,
PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).
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