The goal of this clinical trial is to learn about INS018\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018\_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Anhui Chest Hospital
Hefei, Anhui, China
Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)
TEAEs were either events with start date on or after the start of the Treatment Period and up to 17 days after EOT (end of treatment), or events with start date prior to the start of the Treatment Period whose severity worsened on or after the start of the Treatment Period and up to 17 days after EOT. CTCAE=Common Terminology Criteria for Adverse Events
Time frame: From first dose of study drug until end of study (EOS) visit i.e. up to 13 weeks (+10 days)
Relative Change From Baseline in Forced Vital Capacity (FVC)
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Time frame: Week 0/Visit 2 up to Week 12
Absolute Change From Baseline in FVC in L
Decline (change) in FVC is presented from Week 0 to Week 12. FVC was assessed using standardized spirometry equipment.
Time frame: Week 0/Visit 2 up to Week 12
Absolute Change in FVC % Predicted
Absolute change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Time frame: Week 0/Visit 2 up to Week 12
Relative Change in FVC % Predicted
Relative change in FVC % predicted from Week 0 to Week 12 is presented. FVC was assessed using standardized spirometry equipment
Time frame: Week 0/Visit 2 up to Week 12
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The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 12 more locations