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NCT03740724 · ClinicalTrials.gov registry record · Phase 1
A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
A Phase 1 study, sponsored by Castle Creek Biosciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03740724 is a Phase 1 study that was terminated before completion, run by Castle Creek Biosciences. The registered enrollment target is 1 participants.
The verdict
NCT03740724, a Phase 1 study, was terminated before completion, sponsored by Castle Creek Biosciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 is designed to be injected under the skin at the location of the fibrotic lesions where the genetically-modified fibroblast cells will produce MMP-1 to break down excess collagen accumulation. With the FCX-013 therapy, the patient will take an oral compound (Veledimex) to induce MMP-1 protein expression from the injected cells. Once the fibrosis is resolved, the patient will stop taking the oral compound which will stop further MMP-1 production from the injected cells. FCX-013 plus veledimex is being developed in anticipation of improving skin function in patients by resolving fibrotic lesions and normalizing dermal collagen production
Interventions
- DRUG veledimex
- GENETIC FCX-013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2022-04-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03740724
The ClinicalTrials.gov registry entry for NCT03740724 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Castle Creek Biosciences, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which veledimex is the first listed.
NCT03740724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03740724 about?
NCT03740724 is a clinical study titled "A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)". A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for b...
What is the current status of trial NCT03740724?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2019-12-18. Estimated completion is 2022-04-21.
What interventions are being tested in trial NCT03740724?
The interventions under investigation include: veledimex (DRUG), FCX-013 (GENETIC).
Who is sponsoring clinical trial NCT03740724?
This trial is sponsored by Castle Creek Biosciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
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