Not Yet RecruitingPhase 3

An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

80 participantsStarted 2026-07-15

Plain-language summary

The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.

Who can participate

Age range28 Days – 12 Years

SexALL

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Inclusion criteria

✓. ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.
✓. Subject (or caretaker) must be willing to comply with all protocol requirements.
✓. Subjects must complete the SD-007 study.

Exclusion criteria

✕. Subjects who do not meet the entry criteria outlined above.
✕. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator)
✕. Participant is one of the following:
✕. Not of childbearing potential (premenarchal or male/not in possession of a uterus).
✕. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:

What they're measuring

Measuring safety of SD-101-6.0

Timeframe: 1 Year

Trial details

NCT IDNCT07482813

SponsorParadigm Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-19

Contact for this trial

Kathleen Watts

+1-352-586-4083 Cure@Kapadi.com

View on ClinicalTrials.gov More Epidermolysis Bullosa (EB) trials