JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

October 11, 2023 updated by: Jemincare

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Total Lymphocyte Count From Baseline to Week 12
Time Frame: Baseline,Week 12
Baseline,Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: Baseline, 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
Time Frame: Baseline, Week 4, 8,12, and 16
Baseline, Week 4, 8,12, and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jemincare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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