BIPI

A Study in People with Systemic Sclerosis to Test whether BI 685509 has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

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Systemic sclerosis
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All genders
person-wave 18+
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Overview
Principal Investigator: Timothy McAlindon, MD, MPH

The objective of the trial is to assess the efficacy, safety, and tolerability of BI 685509 compared with placebo on a background of local standard of care (SOC) therapy in the treatment of adult patients with early progressive dcSSc and vasculopathy

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Allison Reeves

Study details
Inclusion Criteria
  • Patients must be diagnosed with diffuse cutaneous SSc (widespread skin fibrosis with skin involvement proximal to elbows and/or knees) as defined by LeRoy et al. (R17-0149).
  • SSc disease onset (defined by first non-RP symptom) must be within 5 years of Visit 1.
  • 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 OR
    - New involvement or worsening of one new body are if either chest or abdomen within 6 months of Visit 1 OR
    - Worsening of skin thickening within 6 months of Visit 1 OR
    - At least one tendon friction rub
Exclusion Criteria
  • Any known form of pulmonary hypertension
  • Limited cutaneous SSc at screening. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
  • Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
Study Requirements
  • At least 14 in-person visits to Tufts Medical Center for at least 13 months
  • 12 blood collections
  • 12 urine collections
  • 1 high resolution CT scan