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Follow-up study for the KOI2-002 study in epidermolysis bullosa patients

Follow-up study for the KOI2-002 study in epidermolysis bullosa patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224722
Enrollment
9
Registered
2019-06-10
Start date
2019-07-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystrophic epidermolysis bullosa

Interventions

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with dystrophic epidermolysis bullosa who participated in the KOI2-002 study and received KOI2 treatment.

Exclusion criteria

Exclusion criteria: Patients who are considered inappropriate for the study by the investigator or subinvestigator

Design outcomes

Primary

MeasureTime frame
efficacy Percent change from baseline in the total area of blisters, erosions, and ulcers on the whole body by physician measurement

Secondary

MeasureTime frame
safety -Clinical laboratory tests (hematology test, blood chemistry test, urinalysis) -Adverse events (AEs), treatment-related AEs

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026