Lenus’ Phase 2 Study for Evaluation of the Safety and Efficacy of RGN-137 Topical Gel for Junctional and Dystrophic EB

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About the Study:
Lenus Therapeutics, LLC is currently recruiting for a Phase 2 Clinical Trial for evaluation of the safety and efficacy of RGN-137. RGN-137 is topical hydro gel formulation, containing 0.03% Thymosin beta-4 (Tb4), a naturally occurring peptide produced by the body which has wound healing and anti-inflammatory properties. Tb4 is found in all tissues and in all cell types, the blood, and other body fluids. Tb4 contains 43 amino acids. It appears to have a wide range of regenerative activities, like anti-inflammation, re-epithelialization, and especially, promotions/acceleration of wound repair. The gene for Tb4 has also been found to be one of the first to be upregulated after a wound occurs.  It promotes/accelerates wound repair and regeneration in dermal, ocular, cardiac, and CNS animal models as well as in clinical trials for eye and dermal injuries.

RGN-137 will be evaluated for efficacy and safety compared to a Placebo for 15 subjects with JEB or DEB. Eligible subjects must be 4 years and older and have 1 set of pair wounds of similar size but no necessarily in similar locations. The investigator will select the pair of wounds, and one wound will be applied RGN-137 gel and the other will be applied Placebo gel once a day for up to 84 days. Patients will be blinded to the treatment assignments for each wound, however there is no chance to be treated with only placebo. The maximum study duration for each subject will be approximately 16 weeks and includes a screening period of 2 weeks (7 to 14 days prior to baseline Visit), a treatment period of 12 weeks, and a follow-up period of 2 weeks. There are no blood draws, and the patients can use whatever bandaging they prefer.

Trial Entry Criteria: 

Trial Locations:

Active, Recruiting

  • Texas Dermatology and Laser Specialists: San Antonio, Texas, United States, 78218
    Principal Investigator: John C. Browning, MD
    Contact: Gabriel Leal, 210-660-1157
  • The Children's Hospital of Philadelphia: 3401 Civic Center Blvd, Philadelphia, PA 19104
    Principal Investigator: Leslie Castelo-Soccio, MD, PhD
    Contact: Lisa Catanoso, 215-590-0862
  • Northwestern University: 633 Clark Street, Evanston, IL 60208
    Principal Investigator: Amy Paller, MD
    Contact: A. Paller 312-227-6060 apaller [at] northwestern [dot] edu
  • Cincinnati Children’s Hospital Medical Center: 3333 Burnet Ave E-190, Cincinnati, OH 45229
    Principal Investigator: Anne W Lucky, MD
    Contact: Bret Augsburger 513-803-9009 Bret [dot] Ausgburger [at] cchmc [dot] org
  • SUNY Downstate Medical Center: 450 Clarkson Avenue, Brooklyn, NY 11203
    Principal Investigator: Sharon A. Glick, MD
    Contact: Dr. Sharon Glick 718-270-2991 DermResearch [at] downstate [dot] edu

For more information about this study, contact Shinwook Kang, 609-734-4310 (leave a message), swkang [at] thelenus [dot] com