Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03396393
• Other study ID #: KY41078-201
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 4, 2018
• Last updated: January 18, 2018
• Start date: March 2018
• Est. completion date: December 2022

Study information

• Verified date: January 2018
• Source: Kunming Pharmaceuticals, Inc.
• Contact: Xinyan Li, Ph.D
• Phone: +86-13817688857
• Email: xinyan.li[@]holley.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Pharmaceuticals, Inc.

Outcome

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