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Coronary Artery DiseasePhase 2REC-SAFECADNCT06572267

Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

A Phase 2 study testing Mepolizumab low dose group, Mepolizumab middle dose group and Mepolizumab high dose group in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Mepolizumab low dose group, Mepolizumab middle dose group and Mepolizumab high dose group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteChina
Study dates
16 Oct 2024to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

18629551066

woshigaochao@gmail.com

China1 site, 1 recruiting

  • Ling Tao

    Xi'an, Shannxi, 710032

    Chao Gao, M.D., Ph.D., 86-18629551066, woshigaochao@gmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Mepolizumab low dose group, Mepolizumab middle dose group, Mepolizumab high dose group, Saline
Keywords
Meplazumab, coronary artery disease, inflammation, lipid deposition
Medical subject headings
Coronary Artery Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mepolizumab low dose groupDrug

    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 groupDrug

    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 groupDrug

    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.

  • SalineDrug

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

Study groups in NCT06572267
Study groupRoleWhat they receive
Mepolizumab low dose groupExperimentalMepolizumab (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.
Receives: Drug: Mepolizumab low dose group
Mepolizumab middle dose groupExperimentalMepolizumab (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.
Receives: Drug: Mepolizumab middle dose group
Mepolizumab high dose groupExperimentalMepolizumab (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.
Receives: Drug: Mepolizumab high dose group
Placebo groupPlacebo comparatorSaline, 100 ml, intravenous infusion
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (14)

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

    Measured: 6 months

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

    Measured: 6 months

  3. Changes in inflammatory biomarkers from baseline to follow-up

    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

    Measured: 6 months

  4. Device-oriented clinical endpoint (DoCE)

    Device-oriented clinical endpoint is a composite endpoint including cardiac death, target vessel infarction, and clinically driven target lesion revascularization

    Measured: 1 month and 6 months

  5. Cardiac death

    The individual component of the DoCE

    Measured: 1 month and 6 months

  6. Target vessel infarction

    The individual component of the DoCE

    Measured: 1 month and 6 months

  7. Clinically driven target lesion revascularization

    The individual component of the DoCE

    Measured: 1 month and 6 months

  8. Patient-oriented composite endpoint (PoCE)

    Patient-oriented composite endpoint is a composite endpoint including all-cause death, any stroke, any myocardial infarctions, and any revascularization

    Measured: 1 month and 6 months

  9. All-cause death

    The individual component of the PoCE

    Measured: 1 month and 6 months

  10. Any stroke

    The individual component of the PoCE

    Measured: 1 month and 6 months

  11. Any myocardial infarction

    The individual component of the PoCE

    Measured: 1 month and 6 months

  12. Any revascularization

    The individual component of the PoCE

    Measured: 1 month and 6 months

  13. Changes in gene expression of peripheral blood mononuclear cells

    Measured: 6 months

  14. Any adverse events

    All adverse events (AE) will be recorded and categorized according to CTCAE Ver 5.0

    Measured: 1, 2, 3, 4, 5, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start16 Oct 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572267
Sponsor's protocol ID
KY20242170-F-1
Acronym
REC-SAFECAD
Status last verified
Jan 2026
First submitted
22 Aug 2024
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25824988

  • 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.

    PubMed 38166463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mepolizumab low dose group, Mepolizumab middle dose group and Mepolizumab high dose group in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Gao, M.D., Ph.D. (18629551066, woshigaochao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of high PVAT attenuation coefficient among non-target lesion(s) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572267, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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