Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

NCT03396393 | Unknown Phase 2

• 1 other identifier: KY41078-201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Dihydroartemisinin;Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• SRI,Response at Week 24 according to a combined response index

  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.

  week 24

Secondary Outcomes (4)

• Change from baseline in SLEDAI score

  week 4,8,12,16,20,24

• Change from baseline in PAG score

  week 4,8,12,16,20,24

• Number of days of daily prednisone dose Less than or equal to 7.5 mg/day

  Baseline, Week 24

• Percent of subjects with UPRO <0.5g/24h

  Week 4,12,24

Study Arms (4)

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.

Drug: Dihydroartemisinin tablet

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.

Drug: Dihydroartemisinin tablet

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.

Drug: Dihydroartemisinin tablet

placebo

PLACEBO COMPARATOR

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

Drug: Placebo tablet

Interventions

Dihydroartemisinin tablet DRUG

DHA tablet

Also known as: No other names

Dihydroartemisinin 120mg; Dihydroartemisinin 40mg; Dihydroartemisinin 80mg

Placebo tablet DRUG

Placebo tablet

Also known as: No other names

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 .

Sponsors & Collaborators

• Kunming Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

artenimol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fengchun Zhang, Prof.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyan Li, Ph.D

CONTACT

+86-13817688857; xinyan.li@holley.cn

Wenyu Xu, Ph.D

CONTACT

+86-10-58611349; wenyu.xu@holley.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be received DHA 40mg or DHA 80mg or DHA 120mg or placebo continuously for 24 weeks.

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 11, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 23, 2018

Record last verified: 2018-01