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

NCT ID: NCT02407041

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GR-MD-02

active arm

Group Type: EXPERIMENTAL

GR-MD-02

Intervention Type: DRUG

IV infusion

Interventions

GR-MD-02

IV infusion

Intervention Type: DRUG

Other Intervention Names

galactoarabino-rhamnogalacturonate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galectin Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brooke Army Medical Ctr.

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GT-030

Identifier Type: -

Identifier Source: org_study_id