Lupus Erythematosus, SystemicPhase 2NCT05967520
JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 2 study testing JMKX000189 in people with Lupus Erythematosus, Systemic, run by Jemincare at 17 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- JMKX000189
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 17 sitesChina
- Study dates
- 21 Sep 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
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- Use of cyclosporine, tacrolimus, pimelimus, and sirolimus within 1 month prior to randomization.
- Use of thalidomide or lenalidomide within 2 months prior to randomization.
- Rituximab, telitacicept, or leflunomide were used in the 6 months prior to randomization.
- Use of Belliumab within 3 months prior to randomization.
- Intravenous treatment with cyclophosphamide was received within 6 months prior to randomization or oral treatment with cyclophosphamide within 30 days prior to initial administration.
- 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).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
- Not yet recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
- Not yet recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
- Not yet recruiting
Jining First People's Hospital
Jining, Shandong, 272002
- Not yet recruiting
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, 471003
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
- Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
- Not yet recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
- Not yet recruiting
Xinxiang Central Hospital
Xinxiang, Henan, 453099
About this study
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
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.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- JMKX000189, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000189Drug
JMKX000189 will be administered orally once a day
PlaceboDrug
Placebo will be administered orally once a day
| Study group | Role | What they receive |
|---|---|---|
| JMKX000189 - higher dose | Experimental | Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC. Receives: Drug: JMKX000189 |
| JMKX000189 - lower dose | Experimental | Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC. Receives: Drug: JMKX000189 |
| Placebo | Placebo comparator | Randomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Lymphocyte Count From Baseline to Week 12
Measured: Baseline,Week 12
Secondary outcomes (3)
Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score
Measured: 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
Measured: 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
Measured: Baseline, Week 4, 8,12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start21 Sep 2023
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Zeng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967520
- Sponsor's protocol ID
- JY-R105-201
- Status last verified
- Oct 2023
- First submitted
- 21 Jul 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05967520
- Acronym / sponsor ID
- JY-R105-201
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMKX000189 - higher dose | Experimental | Drug: JMKX000189Randomized 16 patients will be received JMKX000189 at a higher dose in oral continuously from Week 0 to Week 12 in addition to SOC. |
| JMKX000189 - lower dose | Experimental | Drug: JMKX000189Randomized 16 patients will be received JMKX000189 at a lower dose in oral continuously from Week 0 to Week 12 in addition to SOC. |
| Placebo | Placebo comparator | Drug: PlaceboRandomized 16 patients will be received Placebo in oral continuously from Week 0 to Week 12 in addition to SOC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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).
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX000189JMKX000189 will be administered orally once a day | Drug | JMKX000189 - higher dose, JMKX000189 - lower dose |
| PlaceboPlacebo will be administered orally once a day | Drug | Placebo |
Primary outcome
Change in Total Lymphocyte Count From Baseline to Week 12
Time frame: Baseline,Week 12
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Zeng principal investigator
Peking Union Medical College Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMKX000189 in people with Lupus Erythematosus, Systemic, run by Jemincare at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quanquan Yan (+86 16602106063, yanquanquan@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Lymphocyte Count From Baseline to Week 12 (time frame: Baseline,Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.