Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-16

Study Completion Date

2027-03-01

Brief Summary

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The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mepolizumab low dose group

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.05 mg/kg, monthly.

Meperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Group Type EXPERIMENTAL

Mepolizumab low dose group

Intervention Type DRUG

Meperizumab (0.05 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Mepolizumab middle dose group

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.1 mg/kg, monthly.

Meperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Group Type EXPERIMENTAL

Mepolizumab middle dose group

Intervention Type DRUG

Meperizumab (0.1 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Mepolizumab high dose group

Mepolizumab (Jiangsu Pacific Menok Biopharmaceutical Co), 0.2 mg/kg, monthly.

Meperizumab was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Group Type EXPERIMENTAL

Mepolizumab high dose group

Intervention Type DRUG

Meperizumab (0.2 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Placebo group

Saline, 100 ml, intravenous infusion

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

Interventions

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Mepolizumab low dose group

Meperizumab (0.05 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Intervention Type DRUG

Mepolizumab middle dose group

Meperizumab (0.1 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Intervention Type DRUG

Mepolizumab high dose group

Meperizumab (0.2 mg/kg) was dissolved in 1 mL of sterile water and added to 100 mL of saline for intravenous infusion. The intravenous infusion shall be completed within 30 to 60 min.

Intervention Type DRUG

Saline

Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with chronic coronary syndrome
2. Non-target lesions with stenosis ≥50% by visual assessment
3. Angina symptoms manageable via antianginal medication
4. High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)
5. Patients who are able to complete the follow-up and compliant to the prescribed medication

Exclusion Criteria

1. Under the age of 18
2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Concurrent medical condition with a life expectancy of less than 3 years
5. Haemodynamical unstable
6. Known contraindications to medications such as test drug and its components, heparin, or contrast
7. The following criteria are met for any of the laboratory test indicators at the time of screening ①ALT/AST \>3ULN；②TBil ≥2ULN；③WBC\>2ULN；④NEUT\<0.5×109 /L；⑤PLT\<30×109 /L；⑥eGFR \&lt;60 mL/min/1.73 m2（CKD-EPI formula）
8. Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No