NCT02407041

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Galectin Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GR-MD-02	IV infusion

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-04-02
• Last updated: 2020-09-07
• Results posted: 2020-09-07

Locations

1 site across 1 country: United States