JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

NCT05967520 | Unknown Phase 2

• 1 other identifier: JY-R105-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 17

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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Change in Total Lymphocyte Count From Baseline to Week 12

  Baseline,Week 12

Secondary Outcomes (3)

• 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

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

JMKX000189 DRUG

JMKX000189 will be administered orally once a day

JMKX000189 - higher dose; JMKX000189 - lower dose

Placebo DRUG

Placebo will be administered orally once a day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Jemincare: lead

Study Sites (17)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

NOT YET RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, 471003, China

NOT YET RECRUITING

Xinxiang Central Hospital

Xinxiang, Henan, 453099, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337055, China

NOT YET RECRUITING

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

NOT YET RECRUITING

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Jining First People's Hospital

Jining, Shandong, 272002, China

NOT YET RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

NOT YET RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

NOT YET RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanquan Yan

CONTACT

+86 16602106063; yanquanquan@jemincare.com

Yahui Li

CONTACT

+86 13311680015; liyahui@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: September 21, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)