Trial · NCT03740724
A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
NCT03740724, Phase 1, Phase 2, Terminated, Castle Creek Biosciences, LLC.; results first posted 2022-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea). Trials, record NCT03740724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03740724
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
- NCT number
- NCT03740724
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Castle Creek Biosciences, LLC.
- Conditions
- Morphea, Scleroderma, Localized, Scleroderma
- Interventions
- FCX-013, veledimex
- First posted
- 2018-11-14
- Last updated
- 2024-01-23
- Results first posted
- 2022-06-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the Safety of FCX-013 Plus Veledimex | Study initiation through study completion | Safety evaluations include assessment of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs); change in clinical laboratory values; change in vital signs; change in electrocardiograms (ECGs); and incidence of replication-competent lentivirus (RCL) antibodies. |
| Secondary | Evaluate the Antifibrotic Effects of FCX-013 Plus Veledimex | Week 4 | Evaluate the antifibrotic effects of FCX-013 plus veledimex |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate the Safety of FCX-013 Plus Veledimex | Study initiation through study completion | 1 subject enrolled but lost to follow up. No outcome data were collected. | ||
| SECONDARY | Evaluate the Antifibrotic Effects of FCX-013 Plus Veledimex | Week 4 | 1 subject enrolled but lost to follow up. No outcome data were collected. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FCX-013 + Veledimex | 1 | |
| Overall Study | COMPLETED | FCX-013 + Veledimex | 0 | |
| Overall Study | NOT COMPLETED | FCX-013 + Veledimex | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | Skin and subcutaneous tissue disorders | FCX-013 + Veledimex | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FCX-013 + Veledimex | 0 | 1 |
| Total, other adverse events | FCX-013 + Veledimex | 1 | 1 |
| Total, serious adverse events | FCX-013 + Veledimex | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03740724
GET https://conductscience.org/api/trials/v1/NCT03740724/registered