Health TrialsbyHealthPanel

A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus

ConditionDiscoid Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKunming Pharmaceuticals, Inc.

About this trial

This study is a multicentre, randomised, double-blind, double-dummy, phase II clinical trial with a positive-control group, designed to evaluate the efficacy and safety of dihydroartemisinin tablets in the treatment of discoid lupus erythematosus (DLE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants are able to understand the purpose and risks of the study and voluntarily sign an informed consent form;

Aged between 18 and 65 years (inclusive);

Body weight ≥ 45 kg;

Diagnosed with discoid lupus erythematosus (DLE) at the screening visit (refer to the '2021 Guidelines for the Diagnosis, Treatment and Long-term Management of Cutaneous Lupus Erythematosus'); new patients must undergo a skin biopsy and provide a pathology report, whilst existing patients must provide a biopsy pathology report dated within the last 5 years;

Disqualifiers

Patients with systemic lupus erythematosus (SLE) or those at high risk of developing SLE;

Drug-induced lupus;

Patients with a history of resistance to antimalarial treatment;

At screening, aspartate transaminase (AST) or alanine transaminase (ALT) or gamma-glutamyltransferase (GGT) levels exceeding twice the upper limit of normal (ULN); or alkaline phosphatase (ALP) or total bilirubin levels exceeding 1.5 times the upper limit of normal (ULN); or serum creatinine (Cr) or urea (UREA) levels exceeding 1.5 times the upper limit of normal (ULN);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dihydroartemisinin tablets

    Drug

    Dihydroartemisinin 40mg, taken orally twice a day, for a treatment period of 24 weeks.

  • Dihydroartemisinin tablets

    Drug

    Dihydroartemisinin 60mg, taken orally twice a day, for a treatment period of 24 weeks.

  • Hydroxychloroquine tablets

    Drug

    Hydroxychloroquine 200mg, taken orally once a day, for a treatment period of 24 weeks.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Treatment Group 1Experimental treatment 1 intervention
Group B: Treatment Group 2Experimental treatment 1 intervention
Group C: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change from baseline in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) score at week 24

Time frame
Week 24

Secondary outcomes

1

Percentage change from baseline in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) score at weeks 2, 4, 8, 12, 16 and 20

Time frame
weeks 2, 4, 8, 12, 16 and 20
2

Change in CLASI-A score from baseline

Time frame
weeks 2, 4, 8, 12, 16, 20 and 24
3

Percentage of participants with a ≥50% reduction in CLASI-A score from baseline (CLASI-50)

Time frame
weeks 2, 4, 8, 12, 16, 20 and 24
4

Percentage of participants with a ≥20% reduction in CLASI-A score from baseline

Time frame
weeks 2, 4, 8, 12, 16, 20 and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kunming Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: