NCT03578029

Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa

A Randomized,Single-Blind, Placebo-controlled, Self-matched Pairing, Independent Evaluated Study to Evaluate the Efficacy and Safety of RGN-137 Topical Gel in Subjects With Junctional and Dystrophic Epidermolysis Bullosa (CELEB)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Lenus Therapeutics, LLC · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the efficacy and safety of RGN-137 topical gel with that of placebo gel for treatment of junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB).

Detailed description

RGN-137 will be evaluated for efficacy and safety compared to a Placebo. A matched-pair design will be used to evaluate RGN-137 treatment versus placebo for treatment of 15 subjects with JEB or DEB. Eligible subject must have 1 set of matched-pair wound. The investigator will assign pair of index wounds, each wound with an area between 5cm2 and 50cm2, inclusive, for the eligible subject on Day 1, and for each pair, one wound will be randomized to receive RGN-137 gel and the other to receive Placebo gel. Subjects and independent evaluator will be blinded to the treatment assignments for each wound.

Conditions

• Junctional Epidermolysis Bullosa
• Dystrophic Epidermolysis Bullosa

Interventions

Type	Name	Description
DRUG	RGN-137	It will be applied topically to the appropriate wound once a day for up to 84 days.
DRUG	Placebo	It will be applied topically to the appropriate wound once a day for up to 84 days.

Timeline

• Start date: 2019-05-22
• Primary completion: 2021-09-01
• Completion: 2021-11-23
• First posted: 2018-07-05
• Last updated: 2022-08-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study