Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Exclusion Criteria21

• Poor pulmonary function (FVC<40% and/or DLCO<30%).
• Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
• Clinically significant pulmonary hypertension requiring drug therapy.
• Clinically significant cardiac disease.
• Chronic or ongoing active infectious disease requiring systemic treatment.
• Seropositivity for human immunodeficiency virus (HIV).
• Active tuberculosis (TB) infection.
• Active viral infection with viral replication of hepatitis B or C virus.
• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
• Peripheral neuropathy at screening Grade 2 or higher.
• Known or suspected hypersensitivity to components of the treatment
• Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
• Any of the following laboratory abnormalities at screening:
• Absolute neutrophils count <2.0 x 109/L
• Hemoglobin <85 g/L
• Platelet count < 100 x 109/L
• AST/SGOT or ALT/SGPT >2.0 UNL
• Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.
• Use of rituximab within the previous 4 months.
• Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
• Current or history of progressive multifocal leukoencephalopathy (PML).