Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

NCT07077486 | Recruiting Phase 4 DMC

• 1 other identifier: Tongji Hospital
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus or SLE; Interstitial Lung Disease; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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)

  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]

  At baseline and at week 24, 52

• Anti-double-stranded DNA antibody conversion ratio

  At baseline and at week 12, 24, and 52

• Complement C3 and C4 levels return to normal ratios

  At baseline and at week 12, 24, and 52

• Six minutes walking distance

  At baseline and at week 12, 24, and 52

• Changes from baseline in cumulative corticosteroid dose at week 52

  At baseline and at week 52

Study Arms (2)

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.

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.

Drug: Methylprednisolone (Corticosteroid); Drug: Immunosuppressant other than CYC; Drug: Cyclophosphamide (CYC)

Interventions

Methylprednisolone (Corticosteroid) DRUG

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.

Also known as: Methyl

glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group; glucocorticoids plus CYC and/or other immunosuppressants

Immunosuppressant other than CYC DRUG

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)

glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group; glucocorticoids plus CYC and/or other immunosuppressants

Telitacicept Freeze-dried powder Injection 80mg DRUG

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.

glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group

Cyclophosphamide (CYC) DRUG

Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week

glucocorticoids plus CYC and/or other immunosuppressants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Right heart catheterization showing cardiac index ≤ 2 L/min/m2;
• Pulmonary hypertension requiring treatment with epoprostenol/traprostacyclin.

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Central Hospital: collaborator
• Wuhan Hospital of Traditional Chinese Medicine: collaborator
• Rongchang Biopharmaceutical: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lung Diseases, Interstitial

Interventions

Methylprednisolone; Adrenal Cortex Hormones; Cyclophosphamide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

YIKAI Dr. YU, M.D

CONTACT

+86-15671678920; yuyikai@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Deputy Chief Physician

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: July 22, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): March 25, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)