Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis

What this Trial Is About

Diffuse cutaneous systemic sclerosis (dcSSc) is a serious autoimmune disease causing widespread damage to blood vessels and progressive thickening and scarring of the skin and internal organs. This trial evaluates the safety and effects of Brentuximab vedotin, a targeted antibody-drug therapy, in patients with active dcSSc who experienced a relapse after stopping previous treatment with this drug. The study builds on positive early findings from a Phase II trial that showed short-term safety and some benefit in treating this condition. Participants will receive Brentuximab vedotin intravenously at a dose of 0.6 mg per kilogram every three weeks for up to 48 weeks. This open-label extension study allows patients who improved but then relapsed after the initial treatment to continue receiving the drug alongside standard care medications like cyclophosphamide, methotrexate, azathioprine, or mycophenolate mofetil. The trial monitors changes in skin thickness and disease activity, using measures like the modified Rodnan Skin Score and patient and physician assessments at various time points. Throughout the study, participants will undergo regular evaluations including skin thickness measurements, pulmonary function tests, blood tests for inflammatory markers, and questionnaires about health status and disability. Researchers will also assess changes in skin biopsy samples. These assessments will occur at intervals up to 48 weeks to track the drug’s impact and safety. The study aims to provide detailed information on the long-term effects of Brentuximab vedotin treatment for dcSSc patients who relapse after initial therapy.

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc