An Open-Label, Phase 2a Study to Evaluate Safety and Efficacy of GR-MD-02 for Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: GR-MD-02
Intervention description: IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

        Each subject must meet all of the following criteria to be enrolled in this study:

          1. Is capable of understanding the written informed consent, provides signed and
             witnessed written informed consent, and agrees to comply with protocol requirements.

          2. Is between the ages of 18 and 75 years.

          3. Has biopsy proven psoriasis and active moderate to severe plaque psoriasis with a PASI
             of ≥ 12 and at least 10% of involved body surface area.

          4. The patient is not pregnant and must have a negative pregnancy test prior to start of
             the study. Post-menopausal women must have been amenorrheic for at least 12 months to
             be considered of non-child-bearing potential.

          5. Sexually active men or women of childbearing potential must agree to use effective
             means of contraception throughout their participation in this study and for 90 days
             after discontinuation of study medication.

          6. Lactating females must agree to discontinue nursing before the start of study
             treatment and refrain from nursing until 90 days after discontinuation of study
             medication.

          7. Male subjects must refrain from sperm donation throughout the study period and for a
             period of 90 days following the last dose of study drug.

        Exclusion Criteria:

        Subjects meeting any of the following criteria will be excluded from the study:

          1. Any medical illness that is not stable on therapy

          2. Use of any biologic medication for psoriasis within 6 months

          3. Use of or non-biological systemic therapy to include: methotrexate, oral retinoids,
             phototherapy/PUVA, cyclosporine, or any other cytotoxic or immunosuppressive
             medication within 4 weeks of start of study

          4. Topical treatment that is likely to impact signs and symptoms of psoriasis, in the
             opinion of the Principal Investigator, within 2 weeks of the start of the study

          5. Prior exposure to GR-MD-02

          6. Known positivity for Human Immunodeficiency Virus (HIV) infection

          7. Any patient who had major surgery within 8 weeks of Day 1, significant traumatic
             injury, or anticipation of need for major surgical procedure during the study.

          8. Has a history of alcohol/drug abuse.

          9. Any patient who has clinically significant and uncontrolled cardiovascular disease
             (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York
             Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac
             arrhythmia requiring medication, or Grade II or greater peripheral vascular disease
             within 12 months prior to Day 1.

         10. Any patient with concurrent infection including diagnoses of fever of unknown origin
             (FUO) (subjects must be afebrile at the start of therapy).

         11. History of malignant disease with a recurrence of that disease within 5 years of
             follow-up except for those that have been curatively treated including basal or
             squamous cell carcinoma of the skin and in situ carcinoma of the cervix

         12. Participation in an investigational new drug (IND) trial in the 30 days before
             randomization.

         13. Clinically significant medical or psychiatric condition considered a high risk for
             participation in an investigational study.

         14. Has donated or lost a significant volume (>450 mL) of blood or plasma within 30 days
             of the study.

         15. Failure to give informed consent

         16. Subjects with known allergies to the study drug or any of its excipients.

         17. Is an employee or family member of the investigator or study site personnel.