Evaluating SB17170 in patients with idiopathic pulmonary fibrosis

A Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter, Exploratory Phase IIa Clinical Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of SB17170 in Idiopathic Pulmonary Fibrosis (IPF) Patients.

This study is testing a new drug called SB17170 to see if it can help adults with moderate to severe idiopathic pulmonary fibrosis breathe better over 12 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: SPARK Biopharma (Industry-sponsored)
• Locations: 5 sites (Goyang and 4 other locations)
• Trial ID: NCT06747923 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled phase II trial aimed at assessing the efficacy of SB17170 in patients with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants will be randomly assigned to receive either SB17170 or a placebo for a duration of 12 weeks, with the primary outcome being the change in Forced Vital Capacity (FVC) compared to the placebo group. Safety and tolerability will also be monitored throughout the study period. The trial involves adult patients aged 40 and older who have been diagnosed with IPF confirmed by high-resolution computed tomography (HRCT).

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older diagnosed with idiopathic pulmonary fibrosis and a Forced Vital Capacity of 45% or greater.

Not a fit: Patients with primary diseases that may interfere with the study outcomes will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could improve lung function and quality of life for patients suffering from idiopathic pulmonary fibrosis.

How similar studies have performed: Other studies have explored treatments for IPF, but the specific approach of using SB17170 is novel and has not been extensively tested.

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

Where this trial is running

Goyang and 4 other locations

• Myong Ji Hospital — Goyang, South Korea (Recruiting)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea (Recruiting)
• Seoul Asan Hospital — Seoul, South Korea (Not_yet_recruiting)
• The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, South Korea (Not_yet_recruiting)
• Ajou University Hospital — Suwon, South Korea (Not_yet_recruiting)

Study contacts

• Study coordinator: Seong Yun Bang

Conditions IPF; Idiopathic Pulmonary Fibrosis; HMGB1