Title
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Venous Stasis Ulcers
Phase
Phase 2Lead Sponsor
RegeneRx Biopharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Venous Stasis UlcersIntervention/Treatment
thymosin beta-4 ...Study Participants
72The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.
There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days
There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
Inclusion Criteria: Informed Consent Form signed by the patient Male or female, between 18 and 79 years of age At least one venous leg ulceration stable for at least 6 weeks before enrollment Surface area between 3 and 30 cm2 Exclusion Criteria: Have clinical evidence of active infection on the index ulcer Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment History of adverse reaction to any ingredients of the study medication Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers Current or former malignancy Arterial disorder resulting in ulcerated ulcers Diabetes mellitus Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential
| Event Type | Organ System | Event Term | Placebo | Thymosin Beta 4 (Tβ4) at 3 Doses |
|---|
All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE
Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84
