A Phase 2/3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (BLISSc-ILD)

The main purpose of this study is to understand how patients with diffuse cutaneous systemic sclerosis respond to an investigational drug, belimumab. The study drug is being tested to determine if it will work and be safe for the treatment of ILD for patients with diffuse scleroderma and if it helps with other aspects of the disease associated with scleroderma such as skin thickening.

You will be randomly assigned to receive either belimumab or placebo which you will administer by injection once weekly during the duration of the study. A placebo is a harmless inactive substance. This is a double-blind study, which means that you and the study team will not know which group you are in. 

We will use your personal health information, information from the tests and procedures done for the study, and information about how the study drug affects you to help determine if the study drug belimumab is safe and effective in treating dcSSc. 

There are many factors that determine if you are eligible.  Some requirements include: 

• Diagnosed with dcSSc within the last 7 years 

• Skin involvement over upper arms, thighs, chest, or abdomen and over the fingers.

You will be in the study for about 1 year and two months, with 9 visits to the study site.

You are expected to attend all study visits and take the study drug as instructed.  Each visit will last about 1-2 hours. During some or all of the visits, you will have physical exams, lung function tests, ECG (electrocardiogram), blood and urine collection, and complete questionnaires.  You will also have to answer 3 questions in a diary every day. 

Thank you for your interest! If you wish to learn more and sign up for the study, please contact:

LAUREN BAKER

rheumatologyresearch@uphs.upenn.edu
215-614-4417