A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Brief Description Of Study

We are doing this study to find out if lenabasum can help people with diffuse cutaneous systemic sclerosis (SSc) by stopping chronic inflammation. We also want to find out if lenabasum is safe to take without causing too many side effects. Patients will be in this study for 1 year and have 13 study visits. Lenabasum is an experimental, or investigational, drug. This means that lenabasum is not approved by the U.S. Food and Drug Administration (FDA) and can only be used in research studies. This research study will compare lenabasum to placebo. The placebo looks exactly like lenabasum, but does not contain lenabasum.

Detailed Study Description

Patients must have a diagnosis of diffuse cutaneous systemic sclerosis (scleroderma) and not be taking any new or increased doses within the last 8 weeks of non-corticosteroid immunosuppressive medications. 

Clinical Study Identifier: 03398837


Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
I am hoping to hear back from you and discuss details of the study

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