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JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05967520
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : October 13, 2023
Sponsor:
Information provided by (Responsible Party):
Jemincare

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: JMKX000189 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Total Lymphocyte Count From Baseline to Week 12 [ Time Frame: Baseline,Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score [ Time Frame: Baseline, Week 4, 8,12, and 16 ]
  2. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 4,8,12 and 16 [ Time Frame: Baseline, Week 4, 8,12, and 16 ]
  3. 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 [ Time Frame: Baseline, Week 4, 8,12, and 16 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967520


Contacts
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Contact: Quanquan Yan +86 16602106063 yanquanquan@jemincare.com
Contact: Yahui Li +86 13311680015 liyahui@jemincare.com

Locations
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Sponsors and Collaborators
Jemincare
Investigators
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Principal Investigator: Xiaofeng Zeng Peking Union Medical College Hospital
More Information
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Responsible Party: Jemincare
ClinicalTrials.gov Identifier: NCT05967520    
Other Study ID Numbers: JY-R105-201
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: October 13, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases