An Open Label Extension Safety Study to Evaluate SD-101 i... | NCT07482813

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

NCT07482813

Sponsor

Paradigm Therapeutics

Status

Not yet recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

80Estimated

Phase

Phase 3

Conditions

Epidermolysis Bullosa (EB)

Interventions

SD-101 Dermal Cream (6%)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 15, 2026Estimated

Primary Completion Date

Jul 19, 2027Estimated

Completion Date

Aug 19, 2027Estimated

First Submitted Date

Mar 4, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB.

SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SD-101 Dermal Cream (6%)	Active Comparator		Drug: SD-101 Dermal Cream (6%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SD-101 Dermal Cream (6%)	Drug	SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.

Measure	Description	Time Frame
Measuring safety of SD-101-6.0	Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream	1 Year

Eligibility Module

Eligibility Criteria

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:
1. Not of childbearing potential (premenarchal or male/not in possession of a uterus).
2. 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:
  - Abstinence from heterosexual intercourse as a lifestyle choice.
  - Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.
  - Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Kathleen Watts	Contact	+1-352-586-4083		Cure@Kapadi.com
Robert P Ryan, PhD	Contact	919-274-0703		rryan@paradigmtherapeutics.com

Label	URL
Paradigm Therapeutics Website	View source
EB Research Partnership Website	View source
Debra US Website

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic