BridgeMD
New treatment option for IPF
Official title SB17170 Phase 2 Trial in IPF Patients
ClinicalTrials.gov ID: NCT06747923
What this study is testing
What is SB17170?
SB17170 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ipf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is a 2:2:1 randomized, double-blind, placebo-controlled, parallel group, exploratory phase II trial. The main objective of this trial is to compare and evaluate change in FVC compared to placebo by administering SB17170 to moderate to severe patients with IPF.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Adult male/female 40 years or older at the time of obtaining informed consent
- 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...
- Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
You likely can't join if
- When there is a primary disease showing UIP patterns (rheumatoid arthritis-related interstitial lung disease, connective tissue disease-related...
- Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
- Patients with lower respiratory tract infections requiring antibiotic treatment
- Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
- Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
- Patients with evidence of active infection
See the full eligibility criteria
- Adult male/female 40 years or older at the time of obtaining informed consent
- 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
- Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
- Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
- Patients meeting pulmonary function test criteria at the screening visit
- Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form
- 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...
- Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
- Patients with lower respiratory tract infections requiring antibiotic treatment
- Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
- Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
- Patients with evidence of active infection
- 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
- Patients with pulmonary hypertension
- 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
- Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C
The study team makes the final eligibility decision.
Where it's taking place
- Goyang, South Korea
- Gwangmyeong, South Korea
- Seoul, South Korea
- Suwon, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang, South Korea; Gwangmyeong, South Korea; Seoul, South Korea; Suwon, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.