Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men or women aged 18 years and older
Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
FVC (forced vital capacity) ≥ 45% of predicted at screening
DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening
Negative serum pregnancy test in a woman of childbearing potential at the screening visit
Women of childbearing potential must agree to use adequate contraception when sexually active. "Adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.
You may not be if
Limited cutaneous SSc (systemic sclerosis) at screening
Major surgery (including joint surgery) within 8 weeks prior to screening
Hepatic insufficiency classified as Child-Pugh C
Patients with isolated AST or ALT \>3xULN or bilirubin \>2xULN can be included in the trial under the condition of additional monitoring during the trial
Estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m\^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m\^2 will be undergo additional monitoring of renal function
Any prior history of renal crisis
Sitting SBP (systolic blood pressure) \< 95 mmHg at the screening visit
Sitting heart rate \< 50 beats per minute (BPM) at the screening visit
Left ventricular ejection fraction \< 40% prior to screening
Any form of pulmonary hypertension as determined by right heart catheterization
Pulmonary disease with FVC \< 45% of predicted or DLCO (hemoglobin-corrected) \< 40% of predicted at screening
Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
Not permitted prior and concomitant medication
Pregnant or breast feeding women
Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
