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Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

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ClinicalTrials.gov Identifier: NCT03396393
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kunming Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date January 23, 2018
Estimated Study Start Date  ICMJE March 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Dihydroartemisinin tablet
    DHA tablet
    Other Name: No other names
  • Drug: Placebo tablet
    Placebo tablet
    Other Name: No other names
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dihydroartemisinin tablet
  • 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.
    Intervention: Drug: Dihydroartemisinin tablet
  • 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.
    Intervention: Drug: Dihydroartemisinin tablet
  • Placebo Comparator: placebo
    Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC.
    Intervention: Drug: Placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xinyan Li, Ph.D +86-13817688857 xinyan.li@holley.cn
Contact: Wenyu Xu, Ph.D +86-10-58611349 wenyu.xu@holley.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03396393
Other Study ID Numbers  ICMJE KY41078-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: This study has not been decided.
Responsible Party Kunming Pharmaceuticals, Inc.
Study Sponsor  ICMJE Kunming Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fengchun Zhang, Prof. Peking Union Medical College Hospital
PRS Account Kunming Pharmaceuticals, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP