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Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients

NCT02908347 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-01-23

Study results available
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Summary

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.

Conditions

Interventions

DRUG

MP1032

hard gelatine capsules containing 50 mg MP1032 as active ingredient

DRUG

Placebo

hard gelatine capsules without active ingredient

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • MetrioPharm AG

    lead INDUSTRY

Principal Investigators

  • Anke Gauliard, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02908347 on ClinicalTrials.gov