New hope for muscle disease: drug trial launches
NCT ID NCT07355257
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called telitacicept in 30 adults with inflammatory myopathy, a condition where the immune system attacks muscles, causing weakness. The goal is to see if the drug is safe and can control the disease. Participants must have not responded well to standard treatments like steroids.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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