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The primary objective of the study is to assess the efficacy of DHA in patients with SLE.
This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dihydroartemisinin 40mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
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| Dihydroartemisinin 80mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
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| Dihydroartemisinin 120mg | Experimental | Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC. |
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| placebo | Placebo Comparator | Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin tablet | Drug | DHA tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| SRI,Response at Week 24 according to a combined response index | The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in SLEDAI score | Change from baseline in SLEDAI score at week 4,8,12,16,20,24 | week 4,8,12,16,20,24 |
| Change from baseline in PAG score | Change from baseline in PAG score at week 4,8,12,16,20,24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyan Li, Ph.D | Contact | +86-13817688857 | xinyan.li@holley.cn | |
| Wenyu Xu, Ph.D | Contact | +86-10-58611349 | wenyu.xu@holley.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fengchun Zhang, Prof. | Peking Union Medical College Hospital | Principal Investigator |
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This study has not been decided.
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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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| ID | Term |
|---|---|
| C039060 | artenimol |
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Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
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| Placebo tablet | Drug | Placebo tablet |
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| week 4,8,12,16,20,24 |
| Number of days of daily prednisone dose Less than or equal to 7.5 mg/day | Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks | Baseline, Week 24 |
| Percent of subjects with UPRO <0.5g/24h | Percent of subjects with UPRO <0.5g/24h from baseline at Week 4,12,24 | Week 4,12,24 |