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New hope for lupus patients with lung scarring: telitacicept trial launches

NCT ID NCT07077486

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares telitacicept, a newer biologic drug, against the standard treatment cyclophosphamide for lupus patients who also have interstitial lung disease (ILD). About 100 adults with early lupus and ILD will receive either telitacicept or cyclophosphamide, plus usual care. The main goal is to see which drug better preserves lung function over 52 weeks.

What this could mean

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

Active substance
Telitacicept (a biologic drug) compared to cyclophosphamide (standard chemotherapy-like drug), both given alongside standard lupus treatments.
What this could lead to
If successful, telitacicept could offer a safer, more effective option for managing lupus-related lung disease, potentially reducing reliance on harsh immunosuppressants.
What could go wrong
This is a relatively small, early-phase 4 study. Telitacicept may not prove superior to cyclophosphamide, and side effects or lack of lung function improvement are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

Aug 2025

Expected to finish

Mar 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 to 80 years

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: * Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus; * Male or non-pregnant female aged ≥ 18 years; * Diagnosis by high-resolution lung CT (HRCT) is clearly consistent with interstitial lung disease (ILD); * FEV1/FVC%≥60% and diffusion function DLCO (measured value/estimated value) ≥40%; * Patients voluntarily participate in this trial, have good compliance, and have the ability to understand and sign informed consent before the study. Exclusion Criteria: * Alanine aminotransferase and/or aspartate aminotransferase (ALT/AST) \> 5 times the upper limit of normal; * severe chronic kidney disease (stage IV) or need for dialysis (estimated glomerular filtration rate (eGFR) \< 30ml/min/1.73m2); * Hemoglobin \< 80 g/L; * WBC \< 2.0×10\^9; * Platelet \< 50×10\^9; * Is pregnant or breastfeeding; * Expected transfer to another hospital in a non-study site within 4 weeks (possibility of loss to follow-up); * Life expectancy does not exceed 24 weeks; * Have a history of severe allergies; * Patients with other serious lung diseases or other clinically significant serious abnormalities in the lungs; * Are using antitumor drugs, other immunosuppressants or immunomodulatory therapies; * Significant pulmonary hypertension; * Previous clinical or echocardiographic evidence of significant right heart failure; 1. Right heart catheterization showing cardiac index ≤ 2 L/min/m2; 2. Pulmonary hypertension requiring treatment with epoprostenol/traprostacyclin. * Patients with severe cardiovascular disease: 1. myocardial infarction within 6 months; 2. Unstable angina within 6 months. * Risk of bleeding, any of the criteria listed below: 1. known genetic predisposition to bleeding; 2. Patients who require the following treatments: i. Fibrinolytic therapy, full-dose therapeutic anticoagulation (e.g., vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin); ii. High-dose antiplatelet therapy. \[Note: Prophylactic low-dose heparin or heparin flush solution (e.g., enoxaparin, 4000 I.U. S.C. per day) required for maintenance of indwelling intravenous access devices is not prohibited.) and prophylactic antiplatelet therapy (e.g., acetylsalicylic acid up to 325 mg/day, or clopidogrel at a dose of 75 mg/day, or other antiplatelet therapy at the same dose). * History of hemorrhagic central nervous system (CNS) events within 12 months; * Any of the following conditions within a period of 3 months: 1. hemoptysis or hematuria; 2. Active gastrointestinal bleeding or gastrointestinal ulcers; * Have previously undergone hematopoietic stem cell transplantation (HSCT), or plan to receive HSCT in the following year, or plan to undergo major surgery. * Women who are pregnant, breastfeeding or planning to become pregnant during the test; * 28 days before administration or 3 months after administration, women of childbearing age are unwilling or unable to use highly effective contraceptive methods; * According to the investigator's point of view, the patient has alcohol or drug abuse; * History of dysphagia or any gastrointestinal disease that affects drug * Patients with contraindications to the use of tatacept; * Subjects deemed unsuitable for participation in the study by the investigator.

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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

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

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