Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Idiopathic pulmonary fibrosis (IPF) is a progressive respiratory disease characterized by a scarring process of the lung, bringing patients to respiratory failure and death in 3-5 years from diagnosis.
Subjects who meet the inclusion/exclusion criteria as a result of the screening test shall be randomized into Test Group 1 (SB17170 A mg), Test Group 2 (SB17170 B mg) and Control Group (Placebo for SB17170) in 2:2:1. Subjects who have been randomized will orally take 2 capsules once daily after a meal according to their assigned administration group for 12 weeks from the date they are prescribed the investigational product.
Safety and tolerability at 12 weeks after randomization, and efficacy at 4 & 12 weeks will be assessed. The subject who has completed 12 weeks of treatment shall visit the trial site after 1 week (Visit 7, EOS) for a follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB17170 of A mg, Single dose | Experimental |
| |
| SB17170 of B mg, Single dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB17170 | Drug | Taking SB17170 orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in FVC (ml) | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in FVC (%) | Change from baseline in FVC (%) compared to normal predicted values at 12 weeks | Week 12 |
| Change from baseline in DLCO | DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood. |
Not provided
Inclusion 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 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
Exclusion Criteria:
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
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong Yun Bang | Contact | +82-2-887-8032 | sybang@sparkbio.co.kr | |
| Yu Jin Choi | Contact | +82-2-887-9972 | yjchoi@sparkbio.co.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myong Ji Hospital | Recruiting | Goyang | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Taking Placebo orally once a day |
|
| Week 12 |
| Change from baseline in quality of life and symptoms | Living with Pulmonary Fibrosis (L-PF) questionnaire : Scores range from 0 to 100, with higher numbers indicating a greater impairment. | Week 12 |
| Change from baseline in quality of life and symptoms | EuroQoL Five-Dimensional Instrument(EQ-5D) : Scores range from -0.594 to 1.0, with higher numbers indicating a better health | Week 12 |
| Change from baseline in quality of life and symptoms | UCSD Shortness of Breath Questionnaire : Scores range from 0 to 120, with higher numbers indicating greater shortness of breath. | Week 12 |
| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
|
| Seoul Asan Hospital | Not yet recruiting | Seoul | South Korea |
|
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Not yet recruiting | Seoul | South Korea |
|
| Ajou University Hospital | Not yet recruiting | Suwon | South Korea |
|