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An Open-Label, Phase 2a Study to Evaluate Safety and Efficacy of GR-MD-02 for Treatment of Psoriasis

Psoriasis Clinical Trial

Official title:
A Single-Center, Open-Label Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Patients With Moderate to Severe Plaque Psoriasis

Clinical Trial Summary

Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to severe plaque psoriasis

Clinical Trial Description

The overall objective is to establish the safety and efficacy of GR-MD-02 in patients with moderate to severe plaque psoriasis.

Primary objective:

The objective is to evaluate the number of patients with moderate to severe plaque psoriasis who have 75% improvement in Psoriasis Activity Severity Index (PASI-75) following 12 weeks of therapy with GR-MD-02

Secondary objectives:

- To determine the PASI-50 and PASI-100 scores in patients with moderate to severe plaque psoriasis following the first 12 weeks of therapy with GR-MD-02

- To determine the PASI-50, PASI-75, and PASI-100 scores in patients with moderate to severe plaque psoriasis following an additional 12 weeks of therapy (total 24 weeks) with GR-MD-02

- To determine the durability of response to therapy in responders over a one year period following the end of therapy

- To determine whether there is any change in disease status of patients who also have psoriatic arthritis

- To determine the incidence of adverse events and vital sign and laboratory abnormalities during study treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02407041
Study type Interventional
Source Galectin Therapeutics Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2015
Completion date March 2018
View Details
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