A study in people with systemic sclerosis to test whether BI 685509 has an effect on lung function and other systemic sclerosis symptoms

JRCT ID: jRCT2041220079

Registered date:21/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early progressive diffuse cutaneous systemic sclerosis
• Date of first enrollment: 06/03/2023
• Target sample size: 200
• Countries of recruitment: Germany,Japan
• Study type: Interventional

Intervention(s)

IMP administration etc.
BI 685509 will be up-titrated as tolerated

Outcome(s)

• Primary Outcome: FVC(Forced vital capacity)
• Secondary Outcome: mRSS (Modified Rodnan Skin Score)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Male or female patients aged 18 years at time of consent (or above legal age).
- Patients must fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for 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.
- SSc disease onset (defined by first non-RP symptom) must be within 5 years of Visit 1.
- Evidence of active disease.

Exclude 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.
- Any history of scleroderma renal crisis.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology [CKD-EPI] formula) or on dialysis at screening.
- Cirrhosis 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.
- Known, severe gastric antral telangiectasias (watermelon stomach).
- Any history of bronchial artery embolization or massive hemoptysis. (Massive hemoptysis is defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/day over consecutive days).
- Active hemoptysis or pulmonary hemorrhage, including events managed by bronchial artery embolization.
- Systolic blood pressure <100 mm Hg or known history of moderate or severe symptomatic orthostatic dysregulation as judged by the Investigator before start of trial treatment.
- Sitting heart rate (HR) <50 beats per minute (BPM) at the Screening Visit.
- Left ventricular ejection fraction <40% prior to screening.
- A marked baseline prolongation of QT/QTc interval.

Related Information

• Primary Sponsor: Ogawa Shintaro