SB17170 Phase 2 Trial in IPF Patients

Launched by SPARK BIOPHARMA · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial, called the SB17170 Phase 2 Trial, is studying a new treatment for people with Idiopathic Pulmonary Fibrosis (IPF), a serious lung disease that makes it hard to breathe. The goal is to see how effective the drug SB17170 is in improving lung function compared to a placebo (a harmless, inactive substance) over a period of 12 weeks. The trial is open to adults aged 40 and older who have been diagnosed with IPF and have a specific level of lung function.

To participate, individuals must be confirmed to have IPF through a special chest scan and meet certain health criteria. Participants will receive either the study drug or the placebo, but neither they nor the researchers will know which one they are getting to ensure the trial is fair. It’s important to note that some people with certain other health conditions or recent health issues may not be eligible to join the study. If you're interested in learning more about this trial or seeing if you qualify, please talk to your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult male/female 40 years or older at the time of obtaining informed consent
• 2. Patients diagnosed with idiopathic pulmonary fibrosis who meet the following criteria:
• • Patients with idiopathic pulmonary fibrosis who are confirmed by chest High-Resolution Computed Tomography (HRCT) scan
• • Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT pattern consistent with a diagnosis of idiopathic pulmonary fibrosis confirmed through central reading of chest HRCT before the baseline visit
• • 3. Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
• • 4. Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
• • 5. Patients meeting pulmonary function test criteria at the screening visit
• • 6. Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form
• Exclusion Criteria:
• • 1. When there is a primary disease showing UIP patterns (rheumatoid arthritis-related interstitial lung disease, connective tissue disease-related interstitial lung disease, etc.) and/or other clinically significant lung abnormalities
• • 2. Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
• • 3. Patients with lower respiratory tract infections requiring antibiotic treatment
• • 4. Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
• • 5. Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
• • 6. Patients with evidence of active infection
• 7. Patients with the following cardiovascular and cerebrovascular diseases at the time of screening:
• • Severe hypertension within 3 months
• • Myocardial infarction or unstable angina within 6 months
• • History of thrombotic events within 6 months
• • Diagnosis of heart failure within 6 months
• • 8. Patients with pulmonary hypertension
• • 9. Patients who are unable to take drugs orally or have a history of major gastrointestinal surgery or pathological findings that may affect the absorption of the investigational product
• • 10. Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C