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

NCT02407041 | Completed Phase 2 Results

• 1 other identifier: GT-030
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

GR-MD-02

EXPERIMENTAL

active arm

Drug: GR-MD-02

Interventions

GR-MD-02 DRUG

IV infusion

Also known as: galactoarabino-rhamnogalacturonate

GR-MD-02

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet all of the following criteria to be enrolled in this study:
• Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
• Is between the ages of 18 and 75 years.
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• Any medical illness that is not stable on therapy
• Use of any biologic medication for psoriasis within 6 months
• 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
• 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
• Prior exposure to GR-MD-02
• Known positivity for Human Immunodeficiency Virus (HIV) infection
• 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.
• Has a history of alcohol/drug abuse.
• 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.
• Any patient with concurrent infection including diagnoses of fever of unknown origin (FUO) (subjects must be afebrile at the start of therapy).
• 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
• Participation in an investigational new drug (IND) trial in the 30 days before randomization.
• Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.
• Has donated or lost a significant volume (\>450 mL) of blood or plasma within 30 days of the study.

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (1)

Brooke Army Medical Ctr.

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

belapectin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vice President of Regulatory Affairs
• Organization: Galectin Therapeutics

horton@galectintherapeutics.com

678-620-3186

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-09

Locations

US (1)