Systemic Lupus Erythematosus
Conditions
Keywords
Dihydroartemisinin;Systemic Lupus Erythematosus
Brief summary
The primary objective of the study is to assess the efficacy of DHA in patients with SLE.
Detailed description
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).
Interventions
DRUGDihydroartemisinin tablet
DHA tablet
DRUGPlacebo tablet
Placebo tablet
Sponsors
Kunming Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology; 2. Positive antinuclear antibodies (ANA); 3. Activity Index (SLEDAI) score must be 6-11 points, inclusive; 4. Stable dose of prednisone (\<30mg/d) for at least one month ; 5. Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG); 6. Males or females between 18 and 65 years old; 7. Weight of 45 kg or greater. Key
Exclusion criteria
1. Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ; 2. Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections; 3. Presence of active central nervous system (CNS) disease requiring treatment; 4. Subjects with active, severe SLE disease activity which involves the renal system; 5. Substance abuse or dependence; 6. History of malignant cancer within the last 5 years; 7. Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion; 8. Subjects received any live vaccination within the 30 days prior to Visit 2; 9. Subjects received intravenous immunoglobulin (IVIg) or,plasmapheresis,or High dose prednisone or equivalent (\> 100 mg/day) within 90 days prior to Visit 2; 10. Subjects who have had therapy with cyclophosphamide within 180 days prior to Visit 2 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SRI,Response at Week 24 according to a combined response index | week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in SLEDAI score | week 4,8,12,16,20,24 | Change from baseline in SLEDAI score at week 4,8,12,16,20,24 |
| Change from baseline in PAG score | week 4,8,12,16,20,24 | Change from baseline in PAG score at week 4,8,12,16,20,24 |
| Number of days of daily prednisone dose Less than or equal to 7.5 mg/day | Baseline, Week 24 | Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks |
| Percent of subjects with UPRO <0.5g/24h | Week 4,12,24 | Percent of subjects with UPRO \<0.5g/24h from baseline at Week 4,12,24 |
Contacts
Primary ContactXinyan Li, Ph.D
Backup ContactWenyu Xu, Ph.D
Outcome results
None listed