RECRUITINGPhase 2INTERVENTIONAL
SB17170 Phase 2 Trial in IPF Patients
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.
About This Trial
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. This clinical trial treatment involves administering SB17170 or placebo for 12 weeks.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Adult male/female 40 years or older at the time of obtaining willing to sign a consent form
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 willing to sign a consent form form
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
SB17170
Taking SB17170 orally once a day
DRUG
Placebo
Taking Placebo orally once a day
Locations (5)
Myong Ji Hospital
Goyang, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Seoul Asan Hospital
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea