Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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

11 Participants
are divided into 1 treatment group

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