Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

Study Overview
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Brief Summary
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The primary objective of the study is to assess the efficacy of DHA in patients with SLE.

Detailed Description
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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).

Official Title
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A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Dihydroartemisinin tablet
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology; Positive antinuclear antibodies (ANA); Activity Index (SLEDAI) score must be 6-11 points, inclusive; Stable dose of prednisone (<30mg/d) for at least one month ; Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG); Males or females between 18 and 65 years old; Weight of 45 kg or greater. Key Exclusion Criteria: Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ; Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections; Presence of active central nervous system (CNS) disease requiring treatment; Subjects with active, severe SLE disease activity which involves the renal system; Substance abuse or dependence; History of malignant cancer within the last 5 years; Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion; Subjects received any live vaccination within the 30 days prior to Visit 2; Subjects received intravenous immunoglobulin (IVIg) or,plasmapheresis,or High dose prednisone or equivalent (> 100 mg/day) within 90 days prior to Visit 2; Subjects who have had therapy with cyclophosphamide within 180 days prior to Visit 2 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dihydroartemisinin 40mg<br>Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC. | Drug: Dihydroartemisinin tablet<br>* DHA tablet<br>* Other names: No other names;|
| Experimental: Dihydroartemisinin 80mg<br>Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC. | Drug: Dihydroartemisinin tablet<br>* DHA tablet<br>* Other names: No other names;|
| Experimental: Dihydroartemisinin 120mg<br>Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC. | Drug: Dihydroartemisinin tablet<br>* DHA tablet<br>* Other names: No other names;|
| Placebo Comparator: placebo<br>Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC. | Drug: Placebo tablet<br>* Placebo tablet<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dihydroartemisinin;Systemic Lupus Erythematosus