New hope for lupus patients with lung scarring: telitacicept trial launches
NCT ID NCT07077486
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430030, China
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