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

NCT07557927 | Not Yet Recruiting Phase 2

• 1 other identifier: KPC078-C202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Discoid Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (9)

• 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

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

• Change in CLASI-A score from baseline

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

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

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

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

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

• Percentage of participants with a 4-point reduction in CLASI-A activity score from baseline

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

Study Arms (3)

Treatment Group 1

EXPERIMENTAL

dihydroartemisinin 40 mg, twice daily

Drug: Dihydroartemisinin tablets

Treatment Group 2

EXPERIMENTAL

dihydroartemisinin 60 mg, twice daily

Drug: Dihydroartemisinin tablets

control group

ACTIVE COMPARATOR

hydroxychloroquine 200 mg, once daily

Drug: Hydroxychloroquine tablets

Interventions

Dihydroartemisinin tablets DRUG

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

Treatment Group 1

Hydroxychloroquine tablets DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• At the time of screening, the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) must be ≥4.

You may not qualify if:

• 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);
• Patients diagnosed with anaemia within 3 months prior to randomisation, or patients with haemoglobin levels below 110 g/L at screening;
• Patients who have used any antimalarial drug (hydroxychloroquine sulphate, chloroquine phosphate or chloroquine) within 4 weeks prior to randomisation;
• Patients who have used topical corticosteroids (e.g. mometasone furoate cream or others) or topical calcineurin inhibitors (e.g. tacrolimus ointment or others) within 2 weeks prior to randomisation;
• Patients treated with biologics (e.g. adalimumab, secukinumab or others) within 12 weeks prior to randomisation;
• Patients treated with immunomodulators (e.g. thalidomide, lenalidomide or others) within 4 weeks prior to randomisation;
• Patients who have received live vaccines (e.g. measles vaccine, varicella vaccine or others) within 4 weeks prior to randomisation;
• Patients who have used traditional Chinese medicinal preparations with lupus-modulating effects within 4 weeks prior to randomisation, such as Tripterygium preparations (e.g. Tripterygium glycosides), Paeonia lactiflora total glycosides capsules, Zhengqing Fengtongning, or Euphorbia root tablets;
• History of malignant tumours within the 5 years prior to screening;
• History of acute myocardial infarction, unstable angina, or severe arrhythmias (multifocal frequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation) within the 6 months prior to screening, or New York Heart Association (NYHA) Class III-IV;
• Conditions not effectively controlled at the time of screening or markedly unstable diseases (such as acute pneumonia, pulmonary arterial hypertension, diabetic ketoacidosis, acute pancreatitis, etc.), which, in the investigator's judgement, may confound the study results or expose the participant to undue risk;
• Patients with a history of major organ transplantation (e.g., heart, lung, kidney, liver) or haematopoietic stem cell and/or bone marrow transplantation within the 5 years prior to screening;

Sponsors & Collaborators

• Kunming Pharmaceuticals, Inc.: lead

Study Sites (10)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

artenimol; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yong Cui, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duo Gao, bachelor

CONTACT

0871-68319868-3052; GAODUO5@kpc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)