Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Dihydroartemisinin tablet Drug: Placebo tablet Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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.
Drug: Dihydroartemisinin tablet
DHA tablet
Other Name: No other names

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.
Drug: Dihydroartemisinin tablet
DHA tablet
Other Name: No other names

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.
Drug: Dihydroartemisinin tablet
DHA tablet
Other Name: No other names

Placebo Comparator: placebo
Randomized 30 patients will be received placebo tablets in oral continuously from Week 0 to Week 24 in addition to SOC.
Drug: Placebo tablet
Placebo tablet
Other Name: No other names




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396393


Contacts
Layout table for location contacts
Contact: Xinyan Li, Ph.D +86-13817688857 xinyan.li@holley.cn
Contact: Wenyu Xu, Ph.D +86-10-58611349 wenyu.xu@holley.cn

Sponsors and Collaborators
Kunming Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Fengchun Zhang, Prof. Peking Union Medical College Hospital

Layout table for additonal information
Responsible Party: Kunming Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03396393     History of Changes
Other Study ID Numbers: KY41078-201
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This study has not been decided.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kunming Pharmaceuticals, Inc.:
Dihydroartemisinin;Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents