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BRAVOS for dcSSc - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug, brentuximab vedotin, is safe and will reduce symptoms in people who have dcSSc.

What is the Condition Being Studied?

Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Who Can Participate in the Study?

Adults age 18-70 who have been diagnosed with dcSSC for 5 years or less

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like flipping a coin) to get the study drug, brentuximab vedotin, or a placebo (an inactive pill)
- Have physical exams, EKGs, and echocardiograms (an ultrasound test of your heart)
- Have a tuberculosis skin test, breathing (pulmonary function) test, and routine blood tests
- Have two skin biopsies

Study Details

Full Title
Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study
Principal Investigator
Allergy & Immunology Specialist
Protocol Number
IRB:PRO00086904
NCT:NCT03222492
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698