Trials / Unknown
UnknownNCT04924296
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
A Multicentre, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of fSHR-1314 in Adult Patients With Lupus Nephritis
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo. The study will also assess the safety and tolerability of SHR-1314 in the patient population over the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1314 | SHR-1314 s.c. + Steroids |
| DRUG | Placebo | Placebo s.c. + Steroids |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2021-12-25
- Completion
- 2022-09-03
- First posted
- 2021-06-11
- Last updated
- 2021-06-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04924296. Inclusion in this directory is not an endorsement.