NCT03396393

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kunming Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin tablet	DHA tablet
DRUG	Placebo tablet	Placebo tablet

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2018-01-11
• Last updated: 2018-01-23