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Can a Four-Drug cocktail tame a deadly lung complication of myositis?

NCT ID NCT07775235

Disease control Sponsor: Singapore General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a combination of four immunosuppressant medications can improve survival in people with myositis who develop rapidly progressing interstitial lung disease (RP-ILD), a serious condition with a high early mortality rate. The study will enroll 80 adults with this condition and treat them with a 6-month regimen of steroids, rituximab, tacrolimus, and tofacitinib. The main goal is to see if this approach reduces the risk of death within the first six months of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of four immunosuppressant drugs: steroids (methylprednisolone and prednisolone), rituximab, tacrolimus, and tofacitinib
What this could lead to
If successful, this combination could offer a more effective treatment for a life-threatening lung condition in myositis patients, potentially improving survival rates.
What could go wrong
This is a single-center trial with a modest number of participants, and the combination's effectiveness and safety are not yet proven. The drugs carry risks of infection and other side effects.

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.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Patients currently undergoing treatment with combined immunosuppressive treatment for myositis-associated rapidly progressive interstitial lung disease

Ages

21 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age of 21 years or above; 2. Diagnosis of myositis associated rapidly progressive interstitial lung disease Exclusion Criteria: 1. Age of less than 21 year old;

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Conditions

The condition(s) this trial relates to.

interstitial lung disease juvenile dermatomyositis myositis disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Interstitial lung disease Myositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Singapore General Hospital

    RECRUITING

    Singapore, Singapore

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