Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis

NCT01230138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2012-12-11

No results posted yet for this study

Summary

The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.

Conditions

Interventions

DRUG

Placebo

Placebo tablets

DRUG

FP187

High daily dose of 750mg administered as 250mg TID

DRUG

FP187

High daily dose of 750mg administered as 375mg BID

DRUG

FP187

Low daily dose of 500mg FP187 administered as 250mg BID

DRUG

FP187

Oral tablets, up to 3 times daily for 20 weeks.

Sponsors & Collaborators

  • Forward-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Peder M Andersen, MD · Forward-Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-01-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Entities

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 NCT01230138 on ClinicalTrials.gov