Trials / Completed
CompletedNCT03951259
Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-center, randomized, double-blind, placebo-controlled, phase 2 study. The purpose of the study is to initially evaluate the safety and efficacy of SM934 combined with steroids compared to placebo in adult subjects with active systemic lupus erythematosus (SLE) over a 12-week period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SM934 | In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo. |
| DRUG | Placebos | The placebo pills are made identical to the investigating SM934 in appearance. |
Timeline
- Start date
- 2019-07-24
- Primary completion
- 2023-10-13
- Completion
- 2023-10-19
- First posted
- 2019-05-15
- Last updated
- 2023-10-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03951259. Inclusion in this directory is not an endorsement.