TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)

January 19, 2026 updated by: Zhongming Qiu

Safety and Efficacy of Telitacicept in Inflammatory Myopathies

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

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

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:

  • 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.

Exclusion Criteria:

  • 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).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Treatment group
Drug: Telitacicept 240mg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physician's Global Assessment (PGA) Score
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Zhongming Qiu

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 (Estimated)

February 2, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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