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
BIPI
A Study in People with Systemic Sclerosis to Test whether BI 685509 has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
Systemic sclerosis
All genders
18+
Recruiting now
Overview
Principal Investigator: Timothy McAlindon, MD, MPH
Contact Us
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