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Study on BI 685509 for Adults with Systemic Sclerosis to Assess Effects on Lung Function and Symptoms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for systemic sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. The treatment being tested is a medication called BI 685509, which is taken as a film-coated tablet. The purpose of the study is to determine if BI 685509 can improve lung function and other symptoms associated with systemic sclerosis.

Participants in the study will be randomly assigned to receive either the BI 685509 tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for at least 48 weeks, during which participants will take the tablets orally. Throughout the study, participants will have regular check-ups to monitor their health and assess any changes in their condition.

The main goal is to see if BI 685509 can slow down the decline in lung function over the course of the study. Additionally, researchers will look at other aspects of systemic sclerosis, such as skin symptoms and overall health, to understand the full impact of the treatment. This study aims to provide valuable information on the safety and effectiveness of BI 685509 for people living with systemic sclerosis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, BI 685509, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    You will take the assigned medication orally in the form of a film-coated tablet. The exact dosage and frequency will be provided by the study team. The treatment will last for at least 48 weeks.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include assessments of your lung function and other symptoms related to systemic sclerosis.

  4. Step 4

    End of treatment evaluation

    At the end of the 48-week treatment period, you will undergo a final evaluation. This will include measuring any changes in your symptoms and overall health status.

Who can join the trial?

19 criteria

  • Signed and dated written informed consent before joining the trial. This means you agree to participate after understanding the study details.
  • Must be a male or female aged 18 years or older.
  • Must meet the 2013 ACR/EULAR classification criteria for systemic sclerosis (SSc). These are guidelines used by doctors to diagnose this condition.
  • Must have either limited or diffuse cutaneous SSc. If you have limited cutaneous SSc, you need to test positive for anti Scl-70 antibodies, which are specific proteins in the blood.
  • If you have diffuse cutaneous SSc, the disease must have started within 7 years before the first visit. If you have limited cutaneous SSc, it must have started within 2 years before the first visit.
  • Must show signs of active disease, such as:
    • New onset of SSc within the last 2 years before the first visit.
    • New or worsening skin involvement in two new body areas within 6 months before the first visit.
    • New or worsening skin involvement in one new body area if it is the chest or abdomen within 6 months before the first visit.
    • Worsening of skin thickening by 2 or more points within 6 months before the first visit.
    • At least one tendon friction rub, which is a grating sensation felt over a tendon.
    • Must have elevated biomarkers at the first visit, such as:
      • CRP (C-reactive protein) level of 6 mg/L or higher, which indicates inflammation.
      • Erythrocyte sedimentation rate (ESR) of 28 mm/h or higher, another marker of inflammation.
      • KL-6 level of 1000 U/mL or higher, a marker related to lung involvement.
      • If none of these are met, you can still join if the mDAI (modified Disease Activity Index) is 2.5 or higher.
      • Must have evidence of significant vasculopathy, which is a condition affecting blood vessels, such as:
        • Active digital ulcers (DU) at the first visit, which are sores on the fingers or toes.
        • A documented history of digital ulcers.
        • Previous treatment for Raynaud's phenomenon (RP) with certain medications.
        • RP with elevated CRP of 6 mg/L or higher.
        • If none of these are met, you can still join if you have a confirmed diagnosis of interstitial lung disease (ILD).

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who are unable to comply with the study procedures.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients with unstable or uncontrolled medical conditions.
  • Patients who have had a major surgery within the last 3 months.
  • Patients with a history of certain heart conditions.
  • Patients who are currently taking medications that might interfere with the study treatment.
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Investigated drugs

BI 685509 is an experimental medication being tested for its potential to help people with progressive systemic sclerosis, a condition that affects the skin and internal organs. This medication is taken orally, which means it is swallowed in the form of a pill or liquid. The main goal of using BI 685509 in this trial is to see if it can slow down the worsening of lung function over a period of 48 weeks. Researchers are interested in finding out if this medication can help maintain lung health better than not taking it at all. Participants in the trial will be monitored to see how their lung function changes while taking this medication.

What is already known about the treatment

BI 685509 – BI 685509 is an oral medication currently being studied in clinical trials for its potential to treat progressive systemic sclerosis, a condition that affects the skin and internal organs. The medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It is being tested for its ability to slow down the decline in lung function over a period of 48 weeks. BI 685509 works at the molecular level by targeting specific pathways that may help reduce inflammation and fibrosis, which are key features of systemic sclerosis. It is classified under pharmacological agents that aim to modify disease progression.

Investigated diseases

Systemic Sclerosis – Systemic sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It progresses with the overproduction and accumulation of collagen in the skin and other organs, leading to fibrosis. As the disease advances, it can affect internal organs such as the lungs, heart, and kidneys, causing them to function less effectively. The skin may become thickened and lose its elasticity, and blood vessels may also be affected, leading to issues such as Raynaud's phenomenon. Over time, systemic sclerosis can lead to significant physical changes and impairments. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500332-11-00Protocol code1366-0031Estimated enrolment199 patientsSponsorBoehringer Ingelheim Espana S.A.

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