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Trial · Interventional

TerminatedPhase 2Registry data

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

Short name CELEB

Overview

Status
Terminated
Phase
Phase 2
Enrollment
4 participants (actual)
Sponsor
Lenus Therapeutics, LLC · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
22 May 2019
Primary completion
1 Sept 2021
Completion
23 Nov 2021
First posted
5 Jul 2018
Last update posted
22 Aug 2022
Conditions
Junctional Epidermolysis Bullosa · Dystrophic Epidermolysis Bullosa

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 2

    CELEB

    NCT03578029

    22 May 2019 to 23 Nov 2021

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • RGN-137Drug
  • PlaceboDrug

Arms2

  • Experimental

    RGN-137

    It is formulated as a gel for topical administration.

  • Placebo comparator

    Placebo

    It is composed of the same excipients as RGN-137 formulation without the active ingredient.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to achieving 50% reduction in area of each index wound from Day 1 up to Day 84.

    Time frame · up to Day 84

    Registry description

    This primary endpoint will the time to achieving 50% reduction in area of each index wound from Day 1 up to Day 84, defined as date of the first study visit on which 50% reduction in index wound area is achieved minus date of Day 1 visit.

Secondary outcomes(3)
  1. 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.

    Time frame · up to Day 84

    Registry description

    This secondary endpoint will the time to achieving 50%, 75%, and 100% reduction in area of each index wound from Day 1 up to Day 84, defined as date of the first study visit on which 50% reduction in index wound area is achieved minus date of Day 1 visit.

  2. Incidence of 50%, 75%, and 100% reduction and complete re-epithelialization without drainage in area of each index wound at the scheduled visits.

    Time frame · up to Day 84

    Registry description

    This secondary endpoint will be summarized by treatment using frequency counts and percentages.

  3. Change from Baseline and percent change from Baseline in surface area of each index wound at the scheduled visits.

    Time frame · up to Day 84

    Registry description

    This secondary endpoint will be computed for each treatment group as well as for treatment difference at each visit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female and at least 4 years old with a diagnosis of DEB or JEB * Patients and their parents or guardians must be willing and able to provide written informed consent/assent * Presence of 1 pair of stable index wounds within the specified size range at study 1. Index wounds must have a surface area between 5 cm2 and 50 cm2, inclusive at the screening visit 2. The index wounds selected as pairing must be relatively matched in terms of size and location * Women of childbearing potential must have a negative pregnancy test prior to randomization * Sexually active subjects must agree to use medically accepted methods of contraception during the study Exclusion Criteria: * Have any clinical evidence of local infection of the index lesion * Use of prior or concomitant medication (Any investigational drug within 30 days, Immunotherapy or cytotoxic chemotherapy within 60 days, Systemic steroidal therapy within 30 days, and topical steroidal therapy within 14 days) * History of sensitivity to any component of the treatment * Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the subject's participation in or completion of the study (At the discretion of investigator, participants with cardiomyopathy can participate) * Current or former malignancy, including a history of squamous cell carcinomas * Arterial or venous disorder resulting in ulcerated wounds * Uncontrolled diabetes mellitus * Pregnancy or breastfeeding during the study * Girls or women who have had menarche but have not completed menopause * Any condition or situation likely to cause the subject to be unable or unwilling to participate in the study procedures

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