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New drug aims to protect lungs in autoimmune patients

NCT ID NCT07495033

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether the drug telitacicept can slow the decline in lung function in people with connective tissue disease-related interstitial lung disease (CTD-ILD). About 260 adults with conditions like rheumatoid arthritis or lupus and confirmed lung scarring will receive either telitacicept or a placebo for 52 weeks. The main goal is to see if the drug helps preserve lung volume.

What this could mean

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

Active substance
telitacicept
What this could lead to
If successful, this could provide a new treatment option to slow lung damage in people with connective tissue disease-related lung disease.
What could go wrong
This is a Phase 3 trial, but results may not confirm benefit. The drug could cause side effects or fail to outperform placebo.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Voluntary informed consent provided; 2. Male or female aged ≥ 18 years old; 3. Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SjD) , Systemic sclerosis(SSc),or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria; 4. Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WL-ILD); 5. During screening, FVC%Pred ≥ 45%; 6. During screening, DLCO%Pred(corrected for hemoglobin) ≥ 30%; 7. Stable standard treatment was received before randomization to control ILD and/or connective tissue disease; Exclusion Criteria: 1. Diagnosis of Interstitial lung disease other than CTD-ILD; 2. ILD progresses rapidly within 12 weeks before screening or during screening; 3. During screening, HRCT showed severe emphysema (the degree of emphysema exceeded that of ILD); 4. Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC \<0.7); 5. Pulmonary arterial hypertension requiring therapy, as determined by the investigator; 6. Having diffuse alveolar hemorrhage (DAH) or other pulmonary conditions that may have confounding effects, as well as related signs or symptoms; 7. Unable to complete the pulmonary function test, or requiring supplementary oxygen supply; 8. Clinically significant laboratory abnormalities; 9. QTc interval prolongation on ECG; 10. Allergy to human or mouse-derived biological products, or history of other drug allergies, and the investigator deems that the patient is not eligible to participate. 11. Previous treatments received: * Previous or planned organ transplantation or bone marrow transplantation; * Plasma exchange or extracorporeal light separation exchange was performed within 6 months before randomization, or a plasma filtration device was used; * Any targeted BLyS or APRIL drug treatment was received within 12 weeks before randomization; * Biologic therapy was received within 12 weeks or within 5 half-lives of the corresponding drug (whichever is longer) before randomization; * B-cell depletion drugs were used within 6 months before randomization; * Non-biological systemic immunosuppressive drugs other than standard treatment were used within 4 weeks before randomization; * Anti-fibrotic drugs were used within 4 weeks before randomization; * Cyclophosphamide treatment was received within 6 months before randomization; * Cytotoxic drugs were used within 6 months before randomization; * Intravenous or intramuscular glucocorticoids were used within 4 weeks before randomization; 12. Major surgery within 12 weeks prior to screening or planned during the duration of the study; 13. Received or plan to receive any live vaccine within 28 days prior to randomization; 14. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer); 15. has active hepatitis or a history of severe liver disease; 16. Acute or chronic infection requiring treatment; 17. suffered from symptomatic herpes zoster within 12 weeks prior to screening; 18. Active tuberculosis; 19. HIV infection; 20. History of malignant tumors; 21. Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the trial; 22. History of drug or alcohol abuse or dependence; 23. Pregnant or lactating women, and those intending to become pregnant during the trial; 24. Patients considered unsuitable by the investigator to participate in the trial ;

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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.

  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

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.