Lupus or SLEPhase 4NCT07077486
Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease
A Phase 4 study testing Methylprednisolone (Corticosteroid), Immunosuppressant other than CYC and Telitacicept Freeze-dried powder Injection 80mg in people with Lupus or SLE and Interstitial Lung Disease, run by Tongji Hospital at 1 site in China.
Trial summary
Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus or SLE, Interstitial Lung Disease, Systemic Lupus Erythematosus
- What is being tested?
- Methylprednisolone (Corticosteroid), Immunosuppressant other than CYC and Telitacicept Freeze-dried powder Injection 80mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 25 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 33Show fewer
- 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;
- Right heart catheterization showing cardiac index ≤ 2 L/min/m2;
- Pulmonary hypertension requiring treatment with epoprostenol/traprostacyclin.
- Patients with severe cardiovascular disease:
- myocardial infarction within 6 months;
- Unstable angina within 6 months.
- Risk of bleeding, any of the criteria listed below:
- known genetic predisposition to bleeding;
- Patients who require the following treatments:
- 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:
- hemoptysis or hematuria;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
XIAOFANG LUO, M.D, +86-15617678920, yuyikai@tjh.tjmu.edu.cn
About this study
Official title: A Randomized, Positvel Controlled, Multicenter Study of Effects of Telitacicept vs Cyclophosphamide on Lupus Realted Interstitial Lung Disease
Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.
Read the detailed description
Pulmonary abnormalities are present in up to 60% of patients with SLE, and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus. The study also explores disease mechanisms in lungs and serum immunological interaction, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of lupus-ILD.
- Being tested
- Methylprednisolone (Corticosteroid), Immunosuppressant other than CYC, Telitacicept Freeze-dried powder Injection 80mg, Cyclophosphamide (CYC)
- Medical subject headings
- Lupus Erythematosus, Systemic, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (Corticosteroid)Drug
Also called Methyl
In addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate.
Immunosuppressant other than CYCDrug
The control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period)
Telitacicept Freeze-dried powder Injection 80mgDrug
Telitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week.
Cyclophosphamide (CYC)Drug
Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group | Experimental | Telitacicept 160mg sc qw, plus standard of care therapy including glucocorticoids and/or immunosuppressants other than CYC sush as , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the cyclophosphamide usage was included in the group. Receives: Drug: Methylprednisolone (Corticosteroid); Drug: Immunosuppressant other than CYC; Drug: Telitacicept Freeze-dried powder Injection 80mg |
| glucocorticoids plus CYC and/or other immunosuppressants | Active comparator | All patient in this group were administered with cyclophosphamide. The other immunosuppressants in this group include , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the biological agents like belimumab (Benlysta), anifrolumab (Saphnelo), telitacicept (TaiAi), tocilizumab (Actemra) and rituximab (Rituxan) was included in this group. Receives: Drug: Methylprednisolone (Corticosteroid); Drug: Immunosuppressant other than CYC; Drug: Cyclophosphamide (CYC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted]
Pulmonary function measurement (FEV1/FVC% % post-treatment difference during baseline)
Measured: At baseline and at week 24, 52
Secondary outcomes (6)
Correlation between change from baseline at week 52 in diffusing capacity for carbon monoxide (DLco) [percentage (%) predicted]
Diffuse function DLco measurement (% post-treatment difference at baseline)
Measured: At baseline and at week 24, 52
Anti-double-stranded DNA antibody conversion ratio
Anti-double-stranded DNA antibody conversion ratio
Measured: At baseline and at week 12, 24, and 52
Complement C3 and C4 levels return to normal ratios
Complement C3 and C4 levels return to normal ratios
Measured: At baseline and at week 12, 24, and 52
Six minutes walking distance
The 6-minute walk test (6MWT) is a simple, submaximal exercise test commonly used to assess functional capacity in individuals with interstitial lung disease (ILD). It measures the distance a person can walk in six minutes, and this distance (6MWD) can be correlated with disease severity and prognosis.
Measured: At baseline and at week 12, 24, and 52
Changes from baseline in cumulative corticosteroid dose at week 52
Baseline dose was defined as the average corticosteroid dose (prednisone equivalent for all oral, IV, subcutaneous [SC], or intramuscular [IM] administrations) over the 7 days prior to, but not including, day 0; this was used to model the normalized cumulative baseline dose over 52 weeks. Actual cumulative corticosteroid dose (prednisone equivalent for all oral, IV, SC, or IM administrations) over 52 weeks was calculated
Measured: At baseline and at week 52
Krebs von den Lungen-6
Krebs von den Lungen-6 (KL-6), is a biomarker primarily associated with interstitial lung disease (ILD). It's a high-molecular-weight mucin-like glycoprotein produced by type II alveolar pneumocytes. Elevated KL-6 levels in the blood can indicate the presence, severity, and progression of ILD.
Measured: At baseline and at week 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Aug 2025
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus or SLEStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Wuhan Hospital of Traditional Chinese Medicine, Rongchang Biopharmaceutical, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Principal investigator, YIKAI YU, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077486
- Sponsor's protocol ID
- Tongji Hospital
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Positvel Controlled, Multicenter Study of Effects of Telitacicept vs Cyclophosphamide on Lupus Realted Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07077486
- Acronym / sponsor ID
- Tongji Hospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Central Hospital, Wuhan Hospital of Traditional Chinese Medicine, Rongchang Biopharmaceutical, Johns Hopkins Bloomberg School of Public Health
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.
Detailed description
Pulmonary abnormalities are present in up to 60% of patients with SLE, and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus. The study also explores disease mechanisms in lungs and serum immunological interaction, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of lupus-ILD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group | Experimental | Drug: Methylprednisolone (Corticosteroid), Drug: Immunosuppressant other than CYC, Drug: Telitacicept Freeze-dried powder Injection 80mgTelitacicept 160mg sc qw, plus standard of care therapy including glucocorticoids and/or immunosuppressants other than CYC sush as , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the cyclophosphamide usage was included in the group. |
| glucocorticoids plus CYC and/or other immunosuppressants | Active comparator | Drug: Methylprednisolone (Corticosteroid), Drug: Immunosuppressant other than CYC, Drug: Cyclophosphamide (CYC)All patient in this group were administered with cyclophosphamide. The other immunosuppressants in this group include , tacrolimus, Sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine. None of the biological agents like belimumab (Benlysta), anifrolumab (Saphnelo), telitacicept (TaiAi), tocilizumab (Actemra) and rituximab (Rituxan) was included in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (33 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone (Corticosteroid)Also: MethylIn addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate. | Drug | glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group, glucocorticoids plus CYC and/or other immunosuppressants |
| Immunosuppressant other than CYCThe control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period) | Drug | glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group, glucocorticoids plus CYC and/or other immunosuppressants |
| Telitacicept Freeze-dried powder Injection 80mgTelitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week. | Drug | glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group |
| Cyclophosphamide (CYC)Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week | Drug | glucocorticoids plus CYC and/or other immunosuppressants |
Primary outcome
Correlation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted]
Time frame: At baseline and at week 24, 52
Pulmonary function measurement (FEV1/FVC% % post-treatment difference during baseline)
6 secondary outcomes
Correlation between change from baseline at week 52 in diffusing capacity for carbon monoxide (DLco) [percentage (%) predicted]
Time frame: At baseline and at week 24, 52
Anti-double-stranded DNA antibody conversion ratio
Time frame: At baseline and at week 12, 24, and 52
Complement C3 and C4 levels return to normal ratios
Time frame: At baseline and at week 12, 24, and 52
Six minutes walking distance
Time frame: At baseline and at week 12, 24, and 52
Changes from baseline in cumulative corticosteroid dose at week 52
Time frame: At baseline and at week 52
Krebs von den Lungen-6
Time frame: At baseline and at week 12, 24, and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (Corticosteroid), Immunosuppressant other than CYC and Telitacicept Freeze-dried powder Injection 80mg in people with Lupus or SLE and Interstitial Lung Disease, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YIKAI Dr. YU, M.D (+86-15671678920, yuyikai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between change from baseline at week 52 in forced vital capacity (FVC) [percentage (%) predicted] (time frame: At baseline and at week 24, 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.