Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

NCT ID: NCT03396393

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2022-12-31

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 taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dihydroartemisinin 40mg

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

Group Type: EXPERIMENTAL

Dihydroartemisinin tablet

Intervention Type: DRUG

DHA tablet

Dihydroartemisinin 80mg

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

Group Type: EXPERIMENTAL

Dihydroartemisinin tablet

Intervention Type: DRUG

DHA tablet

Dihydroartemisinin 120mg

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

Group Type: EXPERIMENTAL

Dihydroartemisinin tablet

Intervention Type: DRUG

DHA tablet

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo tablet

Interventions

Dihydroartemisinin tablet

DHA tablet

Intervention Type: DRUG

Placebo tablet

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

No other names; No other names

Eligibility Criteria

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.

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kunming Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengchun Zhang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Central Contacts

Xinyan Li, Ph.D

Role: CONTACT

xinyan.li@holley.cn

+86-13817688857

Wenyu Xu, Ph.D

Role: CONTACT

wenyu.xu@holley.cn

+86-10-58611349

Other Identifiers

KY41078-201

Identifier Type: -

Identifier Source: org_study_id