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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Myong Ji Hospital
Goyang, South Korea
RECRUITINGChung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
RECRUITINGSeoul Asan Hospital
Seoul, South Korea
NOT_YET_RECRUITINGChange from baseline in FVC (ml)
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
Time frame: Week 12
Change from baseline in FVC (%)
Change from baseline in FVC (%) compared to normal predicted values at 12 weeks
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Week 12
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The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, South Korea
NOT_YET_RECRUITINGAjou University Hospital
Suwon, South Korea
NOT_YET_RECRUITING