Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

NCT06572267 | Recruiting Phase 2 DMC

• 1 other identifier: KY20242170-F-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Meplazumab; coronary artery disease; inflammation; lipid deposition

Outcome Measures

Primary Outcomes (1)

• Proportion of high PVAT attenuation coefficient among non-target lesion(s)

  Proportion of high PVAT attenuation coefficient (≥-70.1 HU) among non-target lesion(s) assessed by CCTA

  6 months

Secondary Outcomes (14)

• Change in PVAT attenuation coefficient of non-target lesion(s) from baseline to follow-up

  6 months

• Change in non-target lesion plaque composition as assessed by CCTA from baseline to follow-up

  6 months

• Changes in inflammatory biomarkers from baseline to follow-up

  6 months

• Device-oriented clinical endpoint (DoCE)

  1 month and 6 months

• Cardiac death

  1 month and 6 months

Study Arms (4)

Mepolizumab low dose group

EXPERIMENTAL

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

Mepolizumab middle dose group

EXPERIMENTAL

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

Mepolizumab high dose group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Saline, 100 ml, intravenous infusion

Drug: Saline

Interventions

Mepolizumab low dose group 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 low dose group

Mepolizumab middle dose group 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 middle dose group

Mepolizumab high dose group 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.

Mepolizumab high dose group

Saline DRUG

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

Placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Under the age of 18
• Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
• 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)
• Concurrent medical condition with a life expectancy of less than 3 years
• Haemodynamical unstable
• Known contraindications to medications such as test drug and its components, heparin, or contrast
• 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 \&amp;lt;60 mL/min/1.73 m2（CKD-EPI formula）
• Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

RECRUITING

Related Publications (2)

• Sturhan H, Ungern-Sternberg SN, Langer H, Gawaz M, Geisler T, May AE, Seizer P. Regulation of EMMPRIN (CD147) on monocyte subsets in patients with symptomatic coronary artery disease. Thromb Res. 2015 Jun;135(6):1160-4. doi: 10.1016/j.thromres.2015.03.022. Epub 2015 Mar 20.

  PMID: 25824988 BACKGROUND

• Lv JJ, Wang H, Zhang C, Zhang TJ, Wei HL, Liu ZK, Ma YH, Yang Z, He Q, Wang LJ, Duan LL, Chen ZN, Bian H. CD147 Sparks Atherosclerosis by Driving M1 Phenotype and Impairing Efferocytosis. Circ Res. 2024 Jan 19;134(2):165-185. doi: 10.1161/CIRCRESAHA.123.323223. Epub 2024 Jan 3.

  PMID: 38166463 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Inflammation

Interventions

mepolizumab; Population Groups; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ling Tao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

• Ping Zhu, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D., Ph.D.

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Chao Gao, M.D., Ph.D.

CONTACT

18629551066; woshigaochao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 27, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)