An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
Who is this study for? Patients with Diffuse Cutaneous Systemic Sclerosis
What treatments are being studied? Brentuximab Vedotin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:
• 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.
Locations
Other Locations
Canada
Rheumatology Clinic, St. Joseph's Health Care
RECRUITING
London
Contact Information
Primary
Janet E Pope, PhD
Janet.Pope@sjhc.london.on.ca
519-646-6332
Backup
Amanda Philip
Amanda.Philip@sjhc.london.on.ca
519-646-6000
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 11
Treatments
Experimental: Administration of Brentuximab vedotin
Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg/kg Route of administration: intravenous
Related Therapeutic Areas
Sponsors
Collaborators: Seattle Genetics (now a wholly owned subsidiary of Pfizer), Pfizer
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's