Status:
UNKNOWN
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
Lead Sponsor:
Kunming Pharmaceuticals, Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 tak...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 .
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03396393
Start Date
March 1 2018
End Date
December 1 2022
Last Update
January 23 2018
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