Last updated 7 days ago
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms
200 patients around the world
Available in Spain, Mexico, Chile, Argentina, Brazil
Boehringer Ingelheim
18Research sites
200Patients around the world
This study is for people with
Diffuse sclerosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 trialMale or female patients aged ≥18 years at time of consent (or above legal age, e.g. United Kingdom (UK) ≥16 years)Patients must fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for Systemic sclerosis (SSc)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.1988SSc disease onset (defined by first non-Raynaud's phenomenon (RP) symptom) must be within 5 years of Visit 1Evidence of active disease, defined as having at least one of the following:New onset of SSc within the last 2 years of Visit 1 ORNew skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the 17 body areas defined by Modified Rodnan Skin Score (mRSS) assessment, documented in clinical files) ORNew involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 ORWorsening of skin thickening (≥2 mRSS points) within 6 months of Visit 1 OR≥1 tendon friction rubElevated biomarkers on Visit 1 (screening) defined as at least one of the following:C-reactive protein (CRP) ≥6 mg/L (≥0.6 mg/dL), ORErythrocyte sedimentation rate (ESR) ≥28 mm/h, ORKrebs von den Lungen 6 (KL-6) ≥1000 U/mL.Evidence of significant vasculopathy, defined as:Active Digital ulcer (DU(s)) on Visit 1 ORDocumented history of DU(s), ORPrevious 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) ORRP with elevated CRP ≥6 mg/LIf 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.
- Any known form of pulmonary hypertensionPulmonary disease with FVC <50% of predicted. at screening.Limited cutaneous SSc at screening. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndromeDiffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screeningAny history of scleroderma renal crisis within the last 6 monthsEstimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology (CKD-EPI) formula) or on dialysis at screeningCirrhosis of any Child-Pugh class (A, B or C)Cholestasis at present, or Alkaline phosphatase (ALP) > 4 x Upper limit of normal (ULN), or ALP > 2 x ULN and Gamma-glutamyl transferase (GGT) > 3 x ULN at Screening Further exclusion criteria apply.
Sites
STAT Research - CABA
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Psoriahue Medicina Interdisciplinaria - CABA, Buenos Aires
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
Instituto de Investigación Clínica T y T
Recruiting
Hospital Italiano de La Plata
Recruiting
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Recruiting
EDUMED – Educação em Saúde S/S Ltda
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
StudyVITALISScE™
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Diffuse sclerosis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05559580
