JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: JMKX000189; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Quanquan Yan; Phone Number: +86 16602106063; Email: yanquanquan@jemincare.com
• Study Contact Backup: Name: Yahui Li; Phone Number: +86 13311680015; Email: liyahui@jemincare.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Not yet recruiting
      • The First Affiliated Hospital Of Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100053
      • Not yet recruiting
      • Xuanwu Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Not yet recruiting
      • The First Affiliated Hospital, Sun Yat-sen University
  • Henan
    • Luoyang, Henan, China, 471003
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Xinxiang, Henan, China, 453099
      • Not yet recruiting
      • Xinxiang Central Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Not yet recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • Jiangsu Province Hospital
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Not yet recruiting
      • Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130033
      • Not yet recruiting
      • China-Japan Union Hospital of Jilin University
  • Shandong
    • Binzhou, Shandong, China, 256603
      • Not yet recruiting
      • Binzhou Medical University Hospital
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Qilu Hospital of Shandong University
    • Jining, Shandong, China, 272002
      • Not yet recruiting
      • Jining First People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Not yet recruiting
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200040
      • Not yet recruiting
      • Huashan Hospital affiliated to Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Not yet recruiting
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Not yet recruiting
      • West China Hospital Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JMKX000189 - higher dose; Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC.	Drug: JMKX000189; JMKX000189 will be administered orally once a day
Experimental: JMKX000189 - lower dose; Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC.	Drug: JMKX000189; JMKX000189 will be administered orally once a day
Placebo Comparator: Placebo; Randomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC.	Drug: Placebo; Placebo will be administered orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Total Lymphocyte Count From Baseline to Week 12	Baseline,Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score	Baseline, Week 4, 8,12, and 16
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
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

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: JY-R105-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No