Evaluating SB17170 in patients with idiopathic pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sybang@sparkbio.co.kr
• Phone: +82-2-887-8032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

• Nerandomilast in IPF and Progressive Fibrosis: Real-World Data

  This study tests whether nerandomilast helps slow lung function decline in adults with IPF or progressive fibrotic lung disease in routine clinical care.

  Recruiting at 4 sites Tel Aviv Medical Center · Ashkelon and 3 other locations · NCT07919015

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

  This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.