Could a malaria pill tame discoid lupus?
NCT ID NCT07557927
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether dihydroartemisinin, a drug used for malaria, can help treat discoid lupus erythematosus (DLE), a chronic skin condition causing red, scaly patches. Researchers will compare two doses of the drug to a standard lupus treatment (hydroxychloroquine) in 100 adults over 24 weeks. The goal is to see if it reduces skin severity and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dihydroartemisinin tablets
- What this could lead to
- If it works, this could offer a new treatment option for discoid lupus, a chronic skin condition, potentially with fewer side effects than current therapies.
- What could go wrong
- This is an early Phase 2 trial with only 100 people, so results may not apply to everyone. It's also not a cure—patients would still need ongoing management.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants are able to understand the purpose and risks of the study and voluntarily sign an informed consent form; 2. Aged between 18 and 65 years (inclusive); 3. Body weight ≥ 45 kg; 4. 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; 5. At the time of screening, the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) must be ≥4. Exclusion Criteria: 1. Patients with systemic lupus erythematosus (SLE) or those at high risk of developing SLE; 2. Drug-induced lupus; 3. Patients with a history of resistance to antimalarial treatment; 4. 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); 5. Patients diagnosed with anaemia within 3 months prior to randomisation, or patients with haemoglobin levels below 110 g/L at screening; 6. Patients who have used any antimalarial drug (hydroxychloroquine sulphate, chloroquine phosphate or chloroquine) within 4 weeks prior to randomisation; 7. 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; 8. Patients treated with biologics (e.g. adalimumab, secukinumab or others) within 12 weeks prior to randomisation; 9. Patients treated with immunomodulators (e.g. thalidomide, lenalidomide or others) within 4 weeks prior to randomisation; 10. Patients who have received live vaccines (e.g. measles vaccine, varicella vaccine or others) within 4 weeks prior to randomisation; 11. 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; 12. History of malignant tumours within the 5 years prior to screening; 13. 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; 14. 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; 15. 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; 16. A history of chronic, recurrent (three or more episodes of the same type of infection within 52 weeks) or recent severe infections (e.g. pneumonia, sepsis), including viral infections (particularly varicella and herpes zoster), or requiring anti-infective treatment during the screening period; 17. Patients who have undergone any major surgery within 6 weeks prior to randomisation, such as abdominal, thoracic or joint replacement surgery, or who are scheduled to undergo major surgery during the study (including follow-up); 18. Patients for whom the investigator, based on an ophthalmological examination prior to randomisation, considers the findings to be clinically significant and unsuitable for participation in this clinical trial, or who have diseases associated with retinal pathology; 19. Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the clinical trial; 20. Patients with known hypersensitivity to artemisinin-based drugs, hydroxychloroquine or excipients (lactose, microcrystalline cellulose, sodium carboxymethyl starch, sodium dodecyl sulphate, polyvinylpyrrolidone, magnesium stearate); 21. Any other circumstances, as determined by the investigator, that may interfere with the assessment of efficacy. 22. Individuals who abuse drugs or alcohol; 23. Participants who have taken part in any clinical trial within the three months prior to screening (excluding those who underwent safety checks only and did not receive any substantive medication or therapeutic.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
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Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
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Peking University People's Hospital
Beijing, Beijing Municipality, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
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