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This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2173 Injection Group | Experimental |
| |
| SHR-2173 Injection Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 Injection | Drug | SHR-2173 injection in different doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 24. | At Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving SRI-4. | Up to Week 48. | |
| The proportion of participants achieving British Isles Lupus Assessment Group(BILAG) based Composite Lupus Assessment (BICLA). | Up to Week 48. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su Zhang, M.M | Contact | +86-0518-82342973 | su.zhang.sz3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| SHR-2173 Injection Placebo |
| Drug |
SHR-2173 injection placebo. |
|
| The proportion of participants with a ≥ 4-point decrease from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K). | Up to Week 48. |
| The proportion of participants achieving SRI-4 on low-dose corticosteroids in the protocol. | Up to Week 48. |
| The proportion of participants with a daily prednisone (or equivalent) dose of ≤ 7.5 mg (limited to those with baseline corticosteroids > 7.5 mg/day). | Up to Week 48. |
| Change from baseline in Patient's Global Assessment(PGA). | Up to Week 48. |
| The proportion of participants achieving Lupus Low Disease Activity State (LLDAS) in the protocol. | Up to Week 48. |
| The proportion of participants achieving Definitions of Remission In SLE (DORIS) in the protocol. | Up to Week 48. |
| Change from baseline in the level of anti-dsDNA antibody. | Up to Week 48. |
| Change from baseline in the level of complement (C3, C4). | Up to Week 48. |
| Change from baseline in the level of CD19+B cells. | Up to Week 48. |
| Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) in the protocol. | Up to Week 48. |
| Changes from baseline in SLE-Specific Quality-Of-Life (SLEQOL) in the protocol. | Up to Week 48. |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
|