Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to severe plaque psoriasis
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
IV infusion
Brooke Army Medical Ctr.
San Antonio, Texas, United States
Number of Participants With PASI-75, or a 75% Improvement From Baseline in PASI Score
The primary endpoint will be the number of participants with PASI-75, or a 75% improvement from baseline (day 1, prior to first infusion) in PASI score as assessed at the 30 day follow up visit.
Time frame: 6 months
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