Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

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

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

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Dihydroartemisinin tablet; Drug: Placebo tablet

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xinyan Li, Ph.D; Phone Number: +86-13817688857; Email: xinyan.li@holley.cn
• Study Contact Backup: Name: Wenyu Xu, Ph.D; Phone Number: +86-10-58611349; Email: wenyu.xu@holley.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Kunming Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Fengchun Zhang, Prof., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Dihydroartemisinin;Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Artenimol
• Other Study ID Numbers: KY41078-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This study has not been decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No