Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05529134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-31
First Post:
2022-09-01
Brief Title:
Study of PTW-002 in Patients With Dominant or Recessive Dystrophic Epidermolysis Bullosa Due to Mutations in Exon 73 of the COL7A1 Gene
Sponsor:
Phoenicis Therapeutics
Organization:
Phoenicis Therapeutics
Study Overview
Official Title:
A Double-blind Randomized Intra-patient Placebo- Controlled Multiple Dose Study of PTW-002 Evaluating Safety Proof of Mechanism Preliminary Efficacy and Systemic Exposure in Patients With Dominant or Recessive Dystrophic Epidermolysis Bullosa DDEB RDEB Due to Mutations in Exon 73 of the COL7A1 Gene
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind randomized intra-patient placebo- controlled multiple dose study of PTW-002 evaluating safety proof of mechanism preliminary efficacy and systemic exposure in patients with Dominant Dystrophic Epidermolysis Bullosa DDEB or Recessive Dystrophic Epidermolysis Bullosa RDEB due to mutations in exon 73 of the COL7A1 gene Up to two RDEB patients 4 to 17 years of age and up to 6 DDEB patients 4 years of age and older will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None