About this trial
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
Eligibility criteria
Qualifiers
Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
Able to give informed consent.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Brentuximab vedotin
Treatment groups
Sponsors and collaborators
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Seattle Genetics (now a wholly owned subsidiary of Pfizer)
Collaborator
Pfizer
Collaborator