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A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

Testing Avenciguat's impact on lung function in systemic sclerosis patients.

Recruiting
18 years and older
All
Phase 2

This study is for adults with systemic sclerosis (also called scleroderma), a condition that affects skin and organs like the lungs. The research aims to see if a medicine called Avenciguat (BI 685509) can help improve lung function and symptoms of scleroderma. Participants are randomly divided into two groups: one group takes Avenciguat tablets, and the other takes a placebo (a pill that looks the same but has no medicine). The study lasts at least 11 months, but the total time can vary, as participants continue until the last person completes the 11-month treatment. At first, participants visit the study site every 2 weeks, but over time, the visits become less frequent. After the initial treatment period, visits occur every 3 months. During the study, participants will undergo lung tests and fill out questionnaires about their symptoms. Doctors will also check their skin and overall health.

  • Study duration varies, but treatment is at least 11 months.
  • Visits start every 2 weeks, then every 3 months after initial period.
  • Participants may receive compensation for their time and travel.
Study details
    Scleroderma
    Systemic

NCT05559580

Boehringer Ingelheim

13 December 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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