JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus

• Sponsor: Jemincare (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05967520
• Collaborator: (none)
• Enrollment: 48
• Locations: 17
• Arms: 3
• Anticipated Duration (Months): 28.2
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Jul 27, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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

Primary Outcome Measures

1. Change in Total Lymphocyte Count From Baseline to Week 12 [Baseline,Week 12]

Secondary Outcome Measures

1. Change from baseline to Week 4,8,12 and 16 in the modified SLEDAI (mSLEDAI) score [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 [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 [Baseline, Week 4, 8,12, and 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China	233004
2	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
3	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
4	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080
5	The First Affiliated Hospital of Henan University of science and Technology	Luoyang	Henan	China	471003
6	Xinxiang Central Hospital	Xinxiang	Henan	China	453099
7	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
8	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
9	Pingxiang People's Hospital	Pingxiang	Jiangxi	China	337055
10	China-Japan Union Hospital of Jilin University	Changchun	Jilin	China	130033
11	Binzhou Medical University Hospital	Binzhou	Shandong	China	256603
12	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
13	Jining First People's Hospital	Jining	Shandong	China	272002
14	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai	China	200040
15	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200127
16	Shanxi Bethune Hospital	Taiyuan	Shanxi	China	030032
17	West China Hospital Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• Jemincare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jemincare
• ClinicalTrials.gov Identifier: NCT05967520
• Other Study ID Numbers: JY-R105-201
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Aug 1, 2023