To evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis. The study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. It is planned that 108 patients will be randomly assigned to the following three treatment groups for treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
Time frame: Baseline, Week 24
Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Change from Baseline in FVC% (Percent of Predicted FVC value) to Week 4, 8, 12, 16, 20
Time frame: Baseline, Week 4, 8, 12, 16, 20
Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24]
Number of Praticipants with an Acute Exacerbation of IPF
Time frame: Start of Treatment to end of study (approximately 28 weeks)
All-cause mortality
Time frame: Start of Treatment to end of study (approximately 28 weeks)
Adverse events
Time frame: Start of Treatment to end of study (approximately 28 weeks)
Serum concentration of SHR-1906
Time frame: Start of Treatment to end of study (approximately 28 weeks)
Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline
Time frame: Start of Treatment to end of study (approximately 28 weeks)
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