Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

KPC Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Dihydroartemisinin tablet; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03396393

KY41078-201

Details and patient eligibility

About

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

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Dihydroartemisinin 40mg

Experimental group

Description:

Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Treatment:

Drug: Dihydroartemisinin tablet

Dihydroartemisinin 80mg

Experimental group

Description:

Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Treatment:

Drug: Dihydroartemisinin tablet

Dihydroartemisinin 120mg

Experimental group

Description:

Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Treatment:

Drug: Dihydroartemisinin tablet

placebo

Placebo Comparator group

Description:

Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC.

Treatment:

Drug: Placebo tablet