Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2021

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).

Interventions

  • Drug: Dihydroartemisinin tablet
    • DHA tablet
  • Drug: Placebo tablet
    • Placebo tablet

Arms, Groups and Cohorts

  • Experimental: Dihydroartemisinin 40mg
    • Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC.
  • Experimental: Dihydroartemisinin 80mg
    • Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC.
  • Experimental: Dihydroartemisinin 120mg
    • Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC.
  • Placebo Comparator: placebo
    • Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC.

Clinical Trial Outcome Measures

Primary Measures

  • SRI,Response at Week 24 according to a combined response index
    • Time Frame: week 24
    • 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.

Secondary Measures

  • Change from baseline in SLEDAI score
    • Time Frame: week 4,8,12,16,20,24
    • Change from baseline in SLEDAI score at week 4,8,12,16,20,24
  • Change from baseline in PAG score
    • Time Frame: week 4,8,12,16,20,24
    • Change from baseline in PAG score at week 4,8,12,16,20,24
  • Number of days of daily prednisone dose Less than or equal to 7.5 mg/day
    • Time Frame: Baseline, Week 24
    • Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks
  • Percent of subjects with UPRO <0.5g/24h
    • Time Frame: Week 4,12,24
    • Percent of subjects with UPRO <0.5g/24h from baseline at Week 4,12,24

Participating in This Clinical Trial

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 .

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kunming Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fengchun Zhang, Prof., Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Xinyan Li, Ph.D, +86-13817688857, xinyan.li@holley.cn

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