This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rentosertib (INS018\_055) administered orally in Patients with Idiopathic Pulmonary Fibrosis. The purpose of this study is to evaluate if Rentosertib (INS018\_055) works to treat patients with Idiopathic Pulmonary Fibrosis in adults. It will also learn about the safety of Rentosertib (INS018\_055). In this study, Rentosertib (INS018\_055) will be compared to a placebo (a look-alike substance that contains no drug) to investigate if Rentosertib (INS018\_055) works to treat Idiopathic Pulmonary Fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Dosage form: Tablets; Frequency of administration: Orally QD. Other Names: Rentosertib
Dosage Form: Tablet; Frequency of administration: Orally QD.
Anhui Chest Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGthe annual rate of forced vital capacity (FVC; mL) decline over 52 weeks.
Time frame: Weeks 0,4,12,26,39,52
time to first occurrence of any disease progression
including 1) percent predicted forced vital capacity decrease relative to baseline greater than 10%, 2) acute exacerbation of IPF, 3) respiratory-related hospitalization, or 4) death due to respiratory
Time frame: up to 52 weeks
change from baseline to Week 52 in quantitative computed tomography-derived lung fibrosis burden on high-resolution computed tomography(HRCT)
Time frame: week 52
change from baseline in quality of life (QoL) as measured by the patient-reported outcomes questionnaires using King's Brief Interstitial Lung Disease questionnaire (K BILD)
Time frame: Weeks 0,4,12,26,39,52
change from baseline in QoL as measured by the patient-reported outcomes questionnaires using Living with Pulmonary Fibrosis(L-PF)
Time frame: Weeks 0,4,12,26,39,52
change from baseline in hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) over 52 weeks
Time frame: Weeks 0, 52
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGFuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITING...and 37 more locations