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Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

Primary Purpose

Systemic Lupus Erythematosus

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dihydroartemisinin tablet

Placebo tablet

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Dihydroartemisinin;Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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 with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion;
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 .

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Dihydroartemisinin 40mg

Dihydroartemisinin 80mg

Dihydroartemisinin 120mg

placebo

Arm Description

Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in SLEDAI score

Change from baseline in SLEDAI score at 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

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

Percent of subjects with UPRO <0.5g/24h

Percent of subjects with UPRO <0.5g/24h from baseline at Week 4,12,24

Full Information

NCT ID

NCT03396393

First Posted

January 4, 2018

Last Updated

January 18, 2018

Sponsor

Kunming Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03396393

Brief Title

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2018 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kunming Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Dihydroartemisinin;Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dihydroartemisinin 40mg

Arm Type

Experimental

Arm Description

Randomized 30 patients will be received Dihydroartemisinin tablets 40mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Arm Title

Dihydroartemisinin 80mg

Arm Type

Experimental

Arm Description

Randomized 30 patients will be received Dihydroartemisinin tablets 80mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Arm Title

Dihydroartemisinin 120mg

Arm Type

Experimental

Arm Description

Randomized 30 patients will be received Dihydroartemisinin tablets 120mg in oral continuously from Week 0 to Week 24 in addition to SOC.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dihydroartemisinin tablet

Other Intervention Name(s)

No other names

Intervention Description

DHA tablet

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Other Intervention Name(s)

No other names

Intervention Description

Placebo tablet

Primary Outcome Measure Information:

Title

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

Description

Time Frame

week 24

Secondary Outcome Measure Information:

Title

Change from baseline in SLEDAI score

Description

Change from baseline in SLEDAI score at week 4,8,12,16,20,24

Time Frame

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

Title

Change from baseline in PAG score

Description

Change from baseline in PAG score at week 4,8,12,16,20,24

Time Frame

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

Title

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

Description

Number of days of daily prednisone dose Less than or equal to 7.5 mg/day from baseline over 24 weeks

Time Frame

Baseline, Week 24

Title

Percent of subjects with UPRO <0.5g/24h

Description

Percent of subjects with UPRO <0.5g/24h from baseline at Week 4,12,24

Time Frame

Week 4,12,24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. Key Exclusion Criteria: 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 with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion; 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 .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinyan Li, Ph.D

Phone

+86-13817688857

xinyan.li@holley.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wenyu Xu, Ph.D

Phone

+86-10-58611349

wenyu.xu@holley.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fengchun Zhang, Prof.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

This study has not been decided.

Learn more about this trial

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

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