Systemic sclerosis (SSc) is a rare disease that affects the skin, which becomes thick and tight. It can also affect other organs, such as the lungs, heart, kidneys, and digestive system. This happens because the body’s immune system, which is supposed to protect, starts attacking its own tissues. The extent and severity of the impact varies among individuals depending on the organs involved and the progression of the disease. Living with SSc can significantly impact a person’s life in terms of their physical and psychological health, social life, and occupation.

The eSScape study is designed to assess the safety and efficacy of the investigational study drug* compared to a placebo, for the treatment of adults living with SSc.

Patients enrolled in the study will be randomly assigned by a computer to either receive the investigational study drug or placebo. Two out of three participants will be assigned to receive the investigational study drug and one out of three will receive the placebo.

The study is blinded, meaning that neither the study participant nor the study team will know if the participant is receiving the investigational study drug or the placebo.

* The investigational study drug has not been approved by any regulatory agency as efficacy and safety have not been established in SSc.

You may be eligible to participate if you:

• Have been diagnosed with SSc.
• Are at least 18 years old.
• Are not pregnant or actively trying to become pregnant.
• Meet other criteria that the study staff will discuss with you.
• Are willing to have close medical care and follow-up examinations throughout the study.

Enrolled participants will be asked to remain in the study for up to 15 months.

During this period, study participants might need to visit the study site up to 11 times. This will include up to 4 weeks of screening, a 48-week treatment period, and 8 weeks of follow-up after the last dose of study drug was administered.

Both the investigational study drug and placebo are given subcutaneously (with a needle placed underneath the skin) once a week through a pre-filled syringe during the treatment period.

As part of the efficacy and safety measures in the study, all enrolled participants will be monitored and supported by the study team. Part of this process will include a series of health questions, physical examinations, and blood and urine tests.