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CX501

Phase 2

EPIDERMOLYSIS BULLOSA | Small molecule | Rare Disease |Takeda Pharmaceutical Company Limited|Last Updated: Aug 1, 2019

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2009

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

CX501 · 1 trial · 1 indication

Phase 2 1
NCT00987142Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys BullosaEPIDERMOLYSIS BULLOSA
COMPLETED12 Analytics
PHASE2COMPLETED
Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa
EPIDERMOLYSIS BULLOSA
NCT0098714212
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Study Endpoints

Primary Endpoints

Time to epithelization
21 days

Secondary Endpoints

Fibroblast persistence
3, 8 and 12 months
Incidence of Adverse Events
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CX501EXPERIMENTALCultured chimeric skin
Non adherent dressingACTIVE_COMPARATOROcclusive non adherent dressing

Interventions

NameTypeDescription
CX501DRUGCultured chimeric skin
Occlusive non adherent dressingDEVICEApplication of an occlusive non adherent dressing in the skin donor site
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Eligibility Criteria

Age Range28 Days to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Patients of both sexes over 28 days of age. * Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated. * Patients whose legal guardians have given written inf...

Countries:Spain
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