Study on Systemic Sclerosis and Avenciguat: This study is for adults with systemic sclerosis, also known as scleroderma. It focuses on two types: diffuse and limited cutaneous. It aims to find out if a medicine called Avenciguat helps with lung and vascular problems related to scleroderma.
Participants are randomly divided into two groups. One group takes Avenciguat tablets three times a day, while the other takes placebo tablets, which look like Avenciguat but have no medicine. The treatment lasts at least 11 months, and the total time in the study may vary. Initially, participants visit the study site every two weeks, but visits become less frequent, happening every three months after 11 months. Participants undergo regular lung function tests, fill out symptom questionnaires, and have their skin and health checked by doctors.
- Participants will be in the study for at least 11 months, with visits becoming less frequent over time.
- Participants might receive a placebo, a tablet with no medicine, instead of Avenciguat.
- Regular tests and questionnaires are part of the study to monitor health and check if Avenciguat works.