Intervention: Veledimex
Trial phase: Phase 1 | Phase 2
SMILES: CCC[C@@H](N(NC(=O)c1cccc(OC)c1CC)C(=O)c1cc(C)cc(C)c1)C(C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 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
Eligibility criteria:
Inclusion Criteria:

Subject is an adult, ≥ 18 years of age with moderate to severe localized scleroderma/morphea with sclerotic lesions which have been unresponsive to standard of care therapy.
Subject has stable control of localized disease (clinically inactive) over the 3 months prior to Screening and through Baseline
Subject has not participated in previous clinical research study in the 3 months prior to Screening and through Baseline
Subject has provided informed written consent
Female subjects of childbearing potential and male subjects engaging in sexual activity that could lead to pregnancy agree to use adequate birth control regimen
Subject is able to understand the study, cooperate with the study procedures and willing to return to the clinic for the required follow-up visits

Exclusion Criteria:

Subject has a clinically significant skin disorder other than localized scleroderma/morphea in the anatomical area of interest
Subject has localized scleroderma/morphea only located on the face or over a joint, or lesions that can be successfully managed with topical medications or phototherapy
Subject has symptoms consistent with systemic scleroderma that have not been stable, or that require treatment that has not been stable for 3 months prior to Screening and through Baseline
Subject has been treated with UVA1 phototherapy within 2 months prior to Baseline
Subject requires treatment with a non-stable regimen of systemic immunosuppressive therapy, for any medical condition, or plans to initiate such treatment during the study period
Subject requires treatment with a non-stable regimen of physical therapy, for localized scleroderma/morphea, or plans to initiate such treatment during the study period.
Subject has any medical instability limiting ability to travel to the investigative center.
Subject has clinical signs of infection at (or in close proximity to) the target lesion.
Subject has a history of, or current, malignancy at/near site of injection (except basal cell carcinoma or squamous cell carcinoma that have been treated)
Subject has a history of, or current, clinically significant liver abnormalities.
Subject has a history of, or current, clinically significant cardiac abnormalities, or a significant abnormality on ECG
Subject has clinically significant laboratory abnormalities
Subject has active infection with human immunodeficiency virus (HIV), or hepatitis B/C
Subject has an active drug or alcohol addiction
Subject has any known allergy to any of the constituents of the product
Subject has received an interventional chemical or biological investigational study product for the specific treatment of localized scleroderma in the 3 months prior to Screening and through Baseline
Subject is pregnant or nursing or plans to become pregnant or nurse during the study period