Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

• ClinicalTrials.gov Identifier: NCT03396393
• Recruitment Status: Not yet recruiting
• First Posted: January 11, 2018
• Last Update Posted: January 23, 2018
• Sponsor: Kunming Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Kunming Pharmaceuticals, Inc.

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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 .

Contacts and Locations

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

• Principal Investigator: Fengchun Zhang, Prof.; Peking Union Medical College Hospital

More Information

• Responsible Party: Kunming Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03396393
• Other Study ID Numbers: KY41078-201
• First Posted: January 11, 2018
• 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.

• 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:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Dihydroartemisinin; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents