TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)

NCT07355257 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2025-362
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of Telitacicept in the treatment of inflammatory myopathy in patients with inflammatory diseases. The main question it aims to answer is: the safety and effectiveness of Telitacicept in treating inflammatory myopathy.

Conditions

Inflammatory Myopathy

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment (PGA) Score

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Experimental: Treatment group

EXPERIMENTAL

Drug: Telitacicept 240mg

Interventions

Telitacicept 240mg DRUG

On the basis of the original foundational medication regimen, add Telitacicept 240mg administered via subcutaneous injection once a week for a total of 12 weeks.

Experimental: Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 70 years.
• Patient has a confirmed diagnosis of inflammatory myopathy, meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for idiopathic inflammatory myopathies.
• Inadequate response or intolerance to glucocorticoids and/or at least one immunosuppressant.
• The patient or their legal guardian provides written informed consent.

You may not qualify if:

• Female patients who are pregnant, breastfeeding, or planning a pregnancy during the trial period.
• Patients with active infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis, HBsAg-positive patients, or HCV antibody-positive patients.
• Patients with positive test results indicating COVID-19 infection within 1 month prior to baseline.
• Patients with a history of or currently diagnosed malignancy.
• Patients with significant cardiovascular diseases (including severe arrhythmia), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition that, in the investigator's judgment, would interfere with participation in the study or require hospitalization during the trial.
• Patients who have received intravenous immunoglobulin (IVIG) or plasmapheresis within 1 month prior to baseline.
• Patients who have received other targeted biologic therapies, such as rituximab, eculizumab, tocilizumab, etc., within 3 months prior to baseline.
• Patients who have received any live vaccine within 3 months prior to baseline or plan to receive any vaccine during the study period.
• Patients with a known allergy to human-derived biologics.
• Patients currently participating in another clinical trial.
• Patients deemed unsuitable for participation by the investigator for other reasons (e.g., severe psychiatric disorders).

Sponsors & Collaborators

• Zhongming Qiu: lead

MeSH Terms

Conditions

Myositis

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Zhaoyou Meng

CONTACT

0086-023-68774449; mengzhaoyou@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professer

Model Details: Model Description

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 21, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01