JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967520
• Other study ID #: JY-R105-201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Jemincare
• Contact: Quanquan Yan
• Phone: +86 16602106063
• Email: yanquanquan[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial will evaluate pharmacodynamics，pharmacokinetics，safety，and efficacy of JMKX000189 versus placebo in participants with moderately to severely active systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ? or ?, 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).

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• JMKX000189
JMKX000189 will be administered orally once a day
• Placebo
Placebo will be administered orally once a day

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Lymphocyte Count From Baseline to Week 12		Baseline,Week 12
Secondary	Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score		Baseline, Week 4, 8,12, and 16
Secondary	Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 4,8,12 and 16		Baseline, Week 4, 8,12, and 16
Secondary	Percentage of Participants Achieving No worsening in Physician Global Assessment (PGA) of Disease Activity at Week 4,8,12 and 16, No worsening defined as an increase of PGA < 0.3 Points from baseline		Baseline, Week 4, 8,12, and 16