Trial | NCT03396393  Report issue

Title

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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 Started
Mar 31
2018
Anticipated
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Jan 23
2018

Drug Dihydroartemisinin tablet

DHA tablet

  • Other names: No other names

Drug Placebo tablet

Placebo tablet

  • Other names: No other names

Dihydroartemisinin 40mg Experimental

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

Dihydroartemisinin 80mg Experimental

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

Dihydroartemisinin 120mg Experimental

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

placebo Placebo Comparator

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

Criteria 

Key Inclusion Criteria:

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 Criteria:

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 .
No Results Posted