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Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases

NCT07470151 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-13

No results posted yet for this study

Summary

A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the recommended dose for subsequent treatment. At the same time, the PK/PD characteristics of EVM18001 will be evaluated, preliminary efficacy will be observed, and related biomarkers and immunogenicity will be explored.

Conditions

  • System Lupus Erythematosus(SLE)
  • Scleroderma
  • Myasthenia Gravis (MG)

Interventions

BIOLOGICAL

EVM18001 Injection

All enrolled participants will receive multiple doses of EVM18001 according to the assigned dosage group.

Sponsors & Collaborators

  • Everest Medicines (China) Co.,Ltd.

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Qiubai Li, Professor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2026-11-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470151 on ClinicalTrials.gov