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
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1906,-Dose A | Experimental |
| |
| SHR-1906,- Dose B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1906 | Drug | Intravenous injection |
| |
| SHR-1906 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24 | 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 | Baseline, Week 4, 8, 12, 16, 20 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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
Comparison of SHR-1906 injection and placebo
Not provided
Not provided
Not provided
| Drug |
Intravenous injection |
|
| Placebo | Drug | Placebo,Intravenous injection |
|
| Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24 | Baseline, Week 12 and Week 24 |
| Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24 | Baseline, Week 12 and Week 24] |
| Number of Praticipants with an Acute Exacerbation of IPF | Start of Treatment to end of study (approximately 28 weeks) |
| All-cause mortality | Start of Treatment to end of study (approximately 28 weeks) |
| Adverse events | Start of Treatment to end of study (approximately 28 weeks) |
| Serum concentration of SHR-1906 | Start of Treatment to end of study (approximately 28 weeks) |
| Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline | Start of Treatment to end of study (approximately 28 weeks) |