Trial Outcomes & Findings for A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) (NCT NCT03740724)

Last Updated: 2024-01-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Study initiation through study completion

Results posted on

2024-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	FCX-013 + Veledimex Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally. Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FCX-013 + Veledimex n=1 Participants Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily FCX-013: FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally. veledimex: Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Study initiation through study completion

Population: 1 subject enrolled but lost to follow up. No outcome data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4

Population: 1 subject enrolled but lost to follow up. No outcome data were collected.

Evaluate the antifibrotic effects of FCX-013 plus veledimex

Outcome measures

Outcome data not reported

Adverse Events

FCX-013 + Veledimex

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FCX-013 + Veledimex n=1 participants at risk Following the injection of FCX-013, subjects will initiate a 14-day course of veledimex to be taken orally daily FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally. Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration
Skin and subcutaneous tissue disorders Injection site pain	100.0% 1/1 • Number of events 1 • Adverse events were collected from the time the first subject signed the informed consent form until the final visit/contact with the subject and through study completion/termination (approximately 28 months).

Additional Information

Castle Creek Biosciences Clinical Trial Director

Castle Creek Biosciences

Phone: 484-713-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60