Who may be eligible for the 3T Therapy in the Treatment of MDA5-positive Dermatomyositis trial?

Inclusion Criteria: * Aged 18 or above at the time of screening * Diagnosis of MDA5-positive dermatomyositis (EULAR/ACR) during screening, and the following 3 items are met at the same time: 1. The MDA5 titer during screening is ++ or +++; 2. Mild or above decrease in pulmonary diffusing function at screening and baseline; 3. Interstitial extravasation seen on chest CT at screening and baseline * Agree to receive highly effective contraception or sterilized * Subjects are willing and able to comply with study visits and related procedures * Subjects have the ability to understand the research requirements and procedures, voluntarily participate in clinical trials and sign the ICF Exclusion Criteria: * Have received any drug in 3T treatment in the past, but had poor response (including treatment failure or unacceptable treatment-related adverse reactions) * Have received lenalidomide, cyclosporine, or other highly selective or pan-selective JAK inhibitors such as lenalidomide or cyclosporine or other highly selective or pan-selective JAK inhibitors such as baricitinib within 2 weeks before visit D1 or within 5 drug half-lives (if known) agent. * Have received treatment with an immune cell depleting agent (such as rituximab) within 6 months before the D1 visit. * Have received any investigational drug/treatment within 4 weeks or 5 drug half-lives (if known) before visit D1, whichever is longer. * Known or suspected history of immunosuppression/deficiency (including but not limited to invasive opportunistic infections such as aspergillosis, coccidioidomycosis, histoplasmosis, AIDS, listeriosis, even if the infection has resolved) within 6 months prior to visit D1, or there are unusually frequent recurring or persistent infections. * There is a history of malignant tumors within 5 years before the D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma or thyroid malignant tumors or other malignant tumors considered by the researcher to be amenable to 3T treatment). * Positive hepatitis B surface antigen (HBsAg) during screening; or positive hepatitis B core antibody (HBcAb) and positive HBV-DNA; or positive hepatitis C antibody and positive HCV ribonucleic acid (RNA) polymerase chain reaction; or human immune HIV-deficiency virus (HIV) serology was positive. * Subjects with active tuberculosis, latent tuberculosis, or a history of non-tuberculous mycobacterial infection at the time of screening. * Have a history of systemic hypersensitivity reaction to any drug or matrix or excipient in 3T therapy. * Have been vaccinated within 12 weeks before the D1 visit, or plan to receive a live (attenuated) vaccine during the study. * Pregnant or lactating women, or subjects who plan to become pregnant or lactating during the study. * Any other circumstances in which the researcher determines that it is not appropriate to participate in this study

ClinicalTrials.gov record NCT06438679

3T Therapy in the Treatment of MDA5-positive Dermatomyositis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Single-centric Prospective Single-arm Study of 3T Therapy in the Treatment of MDA5-positive Dermatomyositis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.The registry record was last updated on Jun 3, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.

Age18 years old and older

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-arm Phase 4 study gives all participants a daily three-drug regimen called 3T for MDA5-positive dermatomyositis. Adults in the study take the drugs for 12 months and visit the clinic every two weeks for checks and tests. The study records overall survival and treatment-associated adverse events.

What it is studying. The study is testing whether a daily combination of tacrolimus, tofacitinib, and thalidomide (called 3T therapy) is associated with overall survival and what medical problems occur while people take this combination in adults with MDA5-positive dermatomyositis.

What the researchers hope to learn. To describe overall survival in people with MDA5-positive dermatomyositis taking 3T therapy and to measure the incidence of treatment-associated adverse events; to provide safety and effectiveness data on this drug combination.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this clinical trial is to learn if a combination of tacrolimus, tafocitinib and thalidomide (3T therapy) works to treat severe MDA5 positive dermatomyositis in adults. It will also learn about the safety of 3T therapy. The main questions it aims to answer are: Does 3T therapy prolong the overall survival time of MDA5 positive dermatomyositis? What medical problems do participants have when taking 3T therapy? Participants will: Take 3T therapy every day for 12 months Visit the clinic once every 2 weeks for checkups and tests

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Tofacitinib 5 MG

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Aged 18 or above at the time of screening
Diagnosis of MDA5-positive dermatomyositis (EULAR/ACR) during screening, and the following 3 items are met at the same time:
The MDA5 titer during screening is ++ or +++;
Mild or above decrease in pulmonary diffusing function at screening and baseline;
Interstitial extravasation seen on chest CT at screening and baseline
Agree to receive highly effective contraception or sterilized
Subjects are willing and able to comply with study visits and related procedures
Subjects have the ability to understand the research requirements and procedures, voluntarily participate in clinical trials and sign the ICF

Exclusion criteria

Have received any drug in 3T treatment in the past, but had poor response (including treatment failure or unacceptable treatment-related adverse reactions)
Have received lenalidomide, cyclosporine, or other highly selective or pan-selective JAK inhibitors such as lenalidomide or cyclosporine or other highly selective or pan-selective JAK inhibitors such as baricitinib within 2 weeks before visit D1 or within 5 drug half-lives (if known) agent.
Have received treatment with an immune cell depleting agent (such as rituximab) within 6 months before the D1 visit.
Have received any investigational drug/treatment within 4 weeks or 5 drug half-lives (if known) before visit D1, whichever is longer.
Known or suspected history of immunosuppression/deficiency (including but not limited to invasive opportunistic infections such as aspergillosis, coccidioidomycosis, histoplasmosis, AIDS, listeriosis, even if the infection has resolved) within 6 months prior to visit D1, or there are unusually frequent recurring or persistent infections.
There is a history of malignant tumors within 5 years before the D1 visit (except for completely cured cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma or thyroid malignant tumors or other malignant tumors considered by the researcher to be amenable to 3T treatment).
Positive hepatitis B surface antigen (HBsAg) during screening; or positive hepatitis B core antibody (HBcAb) and positive HBV-DNA; or positive hepatitis C antibody and positive HCV ribonucleic acid (RNA) polymerase chain reaction; or human immune HIV-deficiency virus (HIV) serology was positive.
Subjects with active tuberculosis, latent tuberculosis, or a history of non-tuberculous mycobacterial infection at the time of screening.
Have a history of systemic hypersensitivity reaction to any drug or matrix or excipient in 3T therapy.
Have been vaccinated within 12 weeks before the D1 visit, or plan to receive a live (attenuated) vaccine during the study.
Pregnant or lactating women, or subjects who plan to become pregnant or lactating during the study.
Any other circumstances in which the researcher determines that it is not appropriate to participate in this study

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take an oral combination of tofacitinib, thalidomide, and tacrolimus daily for 12 months. They will attend clinic visits about every two weeks for checkups and tests and will undergo clinical assessments and safety monitoring as directed by the study team. Participants must be willing and able to follow study visits and procedures and sign an informed consent form.

How the study is structured. Interventional, single-group (single-arm), open-label Phase 4 study: all participants receive the same 3T drug combination. Participants take the drugs daily for 12 months, attend clinic visits (about every two weeks for monitoring), and outcomes are measured during the study (primary outcome time frame listed as 26 weeks). There is no randomization or placebo group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Dermatomyositis. Does it apply to my diagnosis?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this site under dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 19, 2024
Primary completion: September 2024 (estimated)
Study completion: December 2026 (estimated)
Target enrollment: 133 participants (estimated)
Last updated on registry: Jun 3, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Participating sites (1)

Zhejiang University School of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009 · China

Terms used on this page · explanations by MedicalUpdates.ai

overall survival: The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
during screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
CT: An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
highly effective contraception: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
ICF: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
half-lives: The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
investigational drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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