TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM) | NCT07355257

Studies
TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)

NCT07355257

Sponsor

Zhongming Qiu

Status

Not yet recruiting

Last Update Posted

Jan 21, 2026Actual

Enrollment

30Estimated

Phase

Phase 2Phase 3

Conditions

Inflammatory Myopathy

Interventions

Telitacicept 240mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2026Estimated

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Mar 30, 2027Estimated

First Submitted Date

Jan 19, 2026

First Submission Date that Met QC Criteria

Jan 19, 2026

First Posted Date

Jan 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2026

Last Update Posted Date

Jan 21, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Experimental: Treatment group	Experimental		Drug: Telitacicept 240mg

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases