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Promising drug could save lives in rare, deadly lung disease

NCT ID NCT07631208

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called teclistamab in 24 adults with a severe, rapidly worsening lung disease linked to anti-MDA5 antibodies. The disease has a very poor outlook, with only about 25% of patients surviving 90 days without a lung transplant. Teclistamab aims to improve survival by targeting immune cells that drive the disease. The main goal is to see if more patients can survive without needing a lung transplant.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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.

Ages

18 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: * Patient ≥ 18 years old * MDA5 antibody positivity * ILD confirmed by chest HRCT * Within less than 3 months after disease onset * Refractory after more than 7 days to high dose steroids and two immunosuppressants drugs as first-line treatment. * Confirmation of refractoriness by the national emergency multidisciplinary discussion (MDD), * Worsening of respiratory symptoms with respiratory distress defined by increase in oxygen supply to reach SpO2\>95% or requirement of mechanical ventilation * Written informed consent obtained from the patient or the trusted support person designated in advance by the patient * Patients covered by the French social security system * Effective contraception for woman of childbearing age during treatment and for five months after the last dose of teclistamab. * Effective contraception for men, having a partner of childbearing age, during treatment and for three months after the last dose of teclistamab. Exclusion Criteria: * Patient with known hypersensitivity to teclistamab, substance active or excipients, including sodium or polysorbate * Patient or the trusted person designed by the patient not able to give their consent * Known diagnosis of a serious comorbidity: active cancer, malignant blood disease, ongoing infection, stroke or seizure within 6 months * Patient who received a live vaccine within 4 weeks prior to study inclusion. * Patient under judicial protection, deprivation of liberty * Patient participating in another clinical trial with an investigational medicinal product * Pregnant or breastfeeding woman * Patient on AME (state medical aid)

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Conditions

The condition(s) this trial relates to.

anti-MDA5 dermatomyositis

As listed by the trial registrant

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

Severe rapidly progressive interstitial lung disease associated with anti-MDA5

How to take part

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

  1. 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 ↗

  2. 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.