Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kunming Pharmaceuticals, Inc.
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin

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 .