Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Select a campus/region


  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
  • Healthy Volunteers


This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma.

The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems.

Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months.

During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.


Full study title A Phase II, Randomised, Placebo-controlled, Double-blind, Parallel-group, Efficacy and Safety Study of at least 48 Weeks of Oral BI 685509 Treatment in Adults with Progressive Systemic Sclerosis
Protocol number OCR44288 ID NCT05559580
Phase Phase 2


Inclusion Criteria:

  1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) * Good Clinical Practice (GCP) and local legislation prior to admission to the trial.

  2. Male or female patients aged ≥18 years at time of consent (or above legal age, e.g. United Kingdom (UK) ≥16 years).

  3. Patients must fulfill the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for Systemic sclerosis (SSc).

  4. Patients must be diagnosed with limited or with diffuse cutaneous SSc as defined by LeRoy et al. (R17 0149). Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive.

  5. Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) in patients with diffuse cutaneous SSc must be within 7 years of Visit 1. Limited cutaneous SSc onset must be within 2 years of Visit 1.

  6. Evidence of active disease, defined as having at least one of the following:

    • New onset of SSc within the last 2 years of Visit 1 OR

    • New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the possible 17 body areas defined by Modified Rodnan Skin Score (mRSS) assessment, documented in clinical files) OR

    • New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR

    • Worsening of skin thickening (e.g. ≥2 mRSS points) within 6 months of Visit 1 OR

    • ≥1 tendon friction rub

  7. Elevated biomarkers on Visit 1 (screening) defined as at least one of the following:

    • C-reactive protein (CRP) ≥6 mg/L (≥0.6 mg/dL), OR

    • Erythrocyte sedimentation rate (ESR) ≥28 mm/h, OR

    • Krebs von den Lungen 6 (KL-6) ≥1000 U/mL If none of the three criteria are met or respective test results should not be available, the patient can be entered if the modified Disease Activity Index (mDAI) is ≥ 2.5.

  8. Evidence of significant vasculopathy, defined as:

    • Active Digital ulcer (DU(s)) on Visit 1 OR

    • Documented history of DU(s), OR

    • Previous treatment of RP with prostacyclin analogues or ≥ 1 other medications, including calcium channel blockers, nitrates,, NO donors in any form, including topical; phosphodiesterase 5 (PDE5) inhibitors (e.g. sildenafil, tadalafil, vardenafil); nonspecific PDE5 inhibitors (theophylline, dipyridamole) OR

    • RP with elevated CRP ≥6 mg/L

    • If none of the four criteria above are met, the patient can be entered if the diagnosis of Interstitial lung disease (ILD) has been confirmed Further inclusion criteria apply.

Exclusion Criteria:

  1. Any known form of pulmonary hypertension.

  2. Pulmonary disease with FVC 3 x ULN at Screening.

Further exclusion criteria apply.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.