Evaluating JMKX000189 for treating moderate to severe lupus

A Phase IIa ,Randomized, Double-blind, Placebo-controlled, Dose-exploration Study of JMKX000189 in Treatment of Moderate to Severe Active Systemic Lupus Erythematosus

This study is testing a new drug called JMKX000189 to see if it can help people with moderate to severe lupus feel better while they continue their usual treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Drugs / interventions: Rituximab, Belliumab, cyclophosphamide
• Locations: 17 sites (Bengbu, Anhui and 16 other locations)
• Trial ID: NCT05967520 on ClinicalTrials.gov

What this trial studies

This trial assesses the pharmacodynamics, pharmacokinetics, safety, and efficacy of JMKX000189 compared to a placebo in patients with moderately to severely active systemic lupus erythematosus (SLE). Participants will continue their standard of care treatment while receiving either the investigational drug or placebo. The study aims to determine how well JMKX000189 works in managing symptoms and improving the condition of SLE patients.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with systemic lupus erythematosus who meet specific classification criteria and have been on stable background therapy.

Not a fit: Patients with active lupus nephritis or central nervous system involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from moderate to severe systemic lupus erythematosus.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in targeting systemic lupus erythematosus with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Subjects must have been diagnosed with systemic lupus erythematosus at least 24 weeks prior to screening and must be assessed to meet 2019 EULAR/ACR SLE classification criteria during screening.
2. the subject must meet one of the following at screening: a. ANA titer ≥1:80;b. anti-dsDNA antibody positive; c. Anti-Smith antibody positive.
3. At least one of the following SLE background standard therapies (including no more than one immunosuppressant) was required for 12 weeks prior to randomization, and the dose must remain stable at least 30 days until randomization and throughout study participation.

Exclusion Criteria:

1. Active lupus nephritis (defined as urinary protein \>1g/24 h or urinary total protein/creatinine ratio (UPCR) \>1 mg/mg (113 mg/mmol) within 8 weeks prior to screening or at randomization).
2. Active lupus of the central nervous system (CNS) (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis) within 60 days prior to randomization.
3. Myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, grade III/IV heart failure, or untreated severe sleep apnea occurred ≤6 months before screening.
4. Previous or current atrioventricular block of degree Ⅱ or Ⅲ, sick sinus syndrome, symptomatic bradycardia, atrial flutter or atrial fibrillation, ventricular arrhythmia or syncope associated with heart disease, or other arrhythmia deemed clinically significant and requiring intervention or treatment.
5. A history of severe respiratory disease or interstitial pneumonia or pulmonary fibrosis，which were found by the medical history or lung function test or chest CT examination conducted during screening or within 3 months prior to screening;Or abnormal pulmonary function of medical significance: 1 second forced expiratory volume (FEV1) or forced vital capacity (FVC)\<70% of the expected value, or FEV1 /FVC \< 0.7.
6. Patients with significant abnormalities in liver, renal function and blood routine during screening, including glutamate aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal value;Serum creatinine greater than 1.5 times the upper limit of normal;Hemoglobin \<90g/L;White blood cell count \<2.5×109/L, platelet count (PLT) \<75×109/L;Lymphocyte count \<0.8×109/L;Abnormal results of other laboratory tests may affect the completion of the test or interfere with the test results according to the investigator.
7. Use of cyclosporine, tacrolimus, pimelimus, and sirolimus within 1 month prior to randomization.
8. Use of thalidomide or lenalidomide within 2 months prior to randomization.
9. Rituximab, telitacicept, or leflunomide were used in the 6 months prior to randomization.
10. Use of Belliumab within 3 months prior to randomization.
11. Intravenous treatment with cyclophosphamide was received within 6 months prior to randomization or oral treatment with cyclophosphamide within 30 days prior to initial administration.
12. History of type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus with HbA1c\> 8%, or diabetic subjects with organ involvement (e.g. retinopathy or kidney disease).

Where this trial is running

Bengbu, Anhui and 16 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (Not_yet_recruiting)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Xinxiang Central Hospital — Xinxiang, Henan, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China (Not_yet_recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Binzhou Medical University Hospital — Binzhou, Shandong, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Jining First People's Hospital — Jining, Shandong, China (Not_yet_recruiting)
• Huashan Hospital Affiliated to Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)
• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Xiaofeng Zeng — Peking Union Medical College Hospital
• Study coordinator: Quanquan Yan

Conditions Lupus Erythematosus, Systemic