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RGN-137 for Epidermolysis Bullosa (CELEB Trial)
Phase 2
Waitlist Available
Research Sponsored by Lenus Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 84
Awards & highlights
CELEB Trial Summary
This study is evaluating whether a gel may help treat a rare skin condition.
Eligible Conditions
- Epidermolysis Bullosa
CELEB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 84
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to achieving 50% reduction in area of each index wound from Day 1 up to Day 84.
Secondary outcome measures
Change from Baseline and percent change from Baseline in surface area of each index wound at the scheduled visits.
Incidence of 50%, 75%, and 100% reduction and complete re-epithelialization without drainage in area of each index wound at the scheduled visits.
Time to achieving 50%, 75%, and 100% (with drainage or without drainage) reduction in area of each index wound from Day 1 up to Day 84.
Other outcome measures
Index wound characteristics at the scheduled visits.
CELEB Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RGN-137Experimental Treatment1 Intervention
It is formulated as a gel for topical administration.
Group II: PlaceboPlacebo Group1 Intervention
It is composed of the same excipients as RGN-137 formulation without the active ingredient.
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Who is running the clinical trial?
Lenus Therapeutics, LLCLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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