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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
DHA tablet
Placebo tablet
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.
Time frame: week 24
Change from baseline in SLEDAI score
Change from baseline in SLEDAI score at week 4,8,12,16,20,24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 4,12,24
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