Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease (REC-SAFECAD)

January 22, 2026 updated by: Ling Tao, MD, PhD, Xijing Hospital

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • 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 Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Recruiting
        • Ling Tao
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 <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

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: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Experimental: 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.
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.
Experimental: 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.
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.
Placebo Comparator: Placebo group
Saline, 100 ml, intravenous infusion
Drug: Saline
Intravenous infusion of saline 100 mL shall be completed within 30 to 60 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of high PVAT attenuation coefficient among non-target lesion(s)
Time Frame: 6 months
Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up
Time Frame: 6 months
6 months
Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up
Time Frame: 6 months
6 months
Changes in inflammatory biomarkers from baseline to follow-up
Time Frame: 6 months
Biomarkers including hs-CRP, IL-1, IL-2, IL-4, IL-6, INF-α, IL-8, IL-10, IL-12p70, IL-17, IL-1β, TNF-α and IFN-γ
6 months
Device-oriented clinical endpoint (DoCE)
Time Frame: 1 month and 6 months
Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization
1 month and 6 months
Cardiac death
Time Frame: 1 month and 6 months
The individual component of the DoCE
1 month and 6 months
Target vessel infarction
Time Frame: 1 month and 6 months
The individual component of the DoCE
1 month and 6 months
Clinically driven target lesion revascularization
Time Frame: 1 month and 6 months
The individual component of the DoCE
1 month and 6 months
Patient-oriented composite endpoint (PoCE)
Time Frame: 1 month and 6 months
Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization
1 month and 6 months
All-cause death
Time Frame: 1 month and 6 months
The individual component of the PoCE
1 month and 6 months
Any stroke
Time Frame: 1 month and 6 months
The individual component of the PoCE
1 month and 6 months
Any myocardial infarction
Time Frame: 1 month and 6 months
The individual component of the PoCE
1 month and 6 months
Any revascularization
Time Frame: 1 month and 6 months
The individual component of the PoCE
1 month and 6 months
Changes in gene expression of peripheral blood mononuclear cells
Time Frame: 6 months
6 months
Any adverse events
Time Frame: 1, 2, 3, 4, 5, and 6 months
All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0
1, 2, 3, 4, 5, and 6 months

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Ling Tao, M.D., Ph.D., Xijing Hospital
  • Study Chair: Chao Gao, M.D., Ph.D., Xijing Hospital
  • Study Chair: Ping Zhu, M.D., Ph.D., Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 16, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242170-F-1

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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