Clinical trial NCT03396393: Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Dihydroartemisinin;Systemic Lupus Erythematosus
Lead sponsor: Kunming Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
Primary purpose: TREATMENT

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).

Eligibility 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 .

Primary outcomes:
measure: SRI,Response at Week 24 according to a combined response index
timeFrame: week 24
Secondary outcomes:
measure: Change from baseline in SLEDAI score
timeFrame: week 4,8,12,16,20,24
measure: Change from baseline in PAG score
timeFrame: week 4,8,12,16,20,24
measure: Number of days of daily prednisone dose Less than or equal to 7.5 mg/day
timeFrame: Baseline, Week 24
measure: Percent of subjects with UPRO <0.5g/24h
timeFrame: Week 4,12,24
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fengchun Zhang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: