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

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