Discoid Lupus ErythematosusPhase 2NCT07557927
A Multicentre, Randomised, Double-blind, Positive-control Clinical Trial Evaluating Dihydroartemisinin Tablets for the Treatment of Discoid Lupus Erythematosus
A Phase 2 study testing Dihydroartemisinin tablets and Hydroxychloroquine tablets in people with Discoid Lupus Erythematosus, run by Kunming Pharmaceuticals, Inc. at 10 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Discoid Lupus Erythematosus
- What is being tested?
- Dihydroartemisinin tablets and Hydroxychloroquine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesChina
- Study dates
- 30 Apr 2026to 30 Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- 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);
- 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;
- Pregnant or breastfeeding women, or women of childbearing potential who do not agree to use effective contraception during the clinical trial;
- Patients with known hypersensitivity to artemisinin-based drugs, hydroxychloroquine or excipients (lactose, microcrystalline cellulose, sodium carboxymethyl starch, sodium dodecyl sulphate, polyvinylpyrrolidone, magnesium stearate);
- Any other circumstances, as determined by the investigator, that may interfere with the assessment of efficacy.
- Individuals who abuse drugs or alcohol;
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Hangzhou Third People's Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
About this study
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).
Read the detailed description
Participants are screened during the screening phase, and those meeting the inclusion criteria are enrolled in the study. Enrolled participants were randomised in a 2:2:1 ratio to Treatment Group 1 (dihydroartemisinin 40 mg, twice daily), Treatment Group 2 (dihydroartemisinin 60 mg, twice daily) or the control group (hydroxychloroquine 200 mg, once daily). Participants in all groups will receive treatment for 24 weeks, during which efficacy and safety will be monitored at regular intervals.
- Conditions
- Discoid Lupus Erythematosus
- Being tested
- Dihydroartemisinin tablets, Hydroxychloroquine tablets
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin tabletsDrug
Dihydroartemisinin 40mg, taken orally twice a day, for a treatment period of 24 weeks.
Dihydroartemisinin tabletsDrug
Dihydroartemisinin 60mg, taken orally twice a day, for a treatment period of 24 weeks.
Hydroxychloroquine tabletsDrug
Hydroxychloroquine 200mg, taken orally once a day, for a treatment period of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | dihydroartemisinin 40 mg, twice daily Receives: Drug: Dihydroartemisinin tablets |
| Treatment Group 2 | Experimental | dihydroartemisinin 60 mg, twice daily Receives: Drug: Dihydroartemisinin tablets |
| control group | Active comparator | hydroxychloroquine 200 mg, once daily Receives: Drug: Hydroxychloroquine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI-A) score at week 24
Measured: 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
Measured: weeks 2, 4, 8, 12, 16 and 20
Change in CLASI-A score from baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of participants with a ≥50% reduction in CLASI-A score from baseline (CLASI-50)
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of participants with a ≥20% reduction in CLASI-A score from baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of participants with a 4-point reduction in CLASI-A activity score from baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Percentage of participants achieving a complete response (CR) in CLASI-A (defined as a score of '0')
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Proportion of participants with a post-treatment DLQI (Dermatology Life Quality Index) score reduced by 2 points or more compared to baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Mean change in post-treatment DLQI (Dermatology Life Quality Index) score compared to baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Mean change in post-treatment PGA (Physician Global Assessment) score compared to baseline
Measured: weeks 2, 4, 8, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Cui, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557927
- Sponsor's protocol ID
- KPC078-C202
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No