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RECRUITING
NCT05149768
PHASE2

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

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.

Official title: An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2024-02-14

Completion Date

2026-07-01

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

DRUG

Brentuximab vedotin

Dose 0.6mg/kg will be given every 3 weeks for 16 cycles (48 weeks), in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil (MMF, cellcept) and mycophenolic acid (myfortic)

Locations (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, Canada