Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Sponsor
Tongji Hospital
Study ID
NCT07077486
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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)
  • 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.
  • Cyclophosphamide (CYC) — DRUG
    Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Jan 2026
Primary completion
Oct 25, 2026
Completion
Mar 25, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: glucocorticoids and/or immunosuppressants other than CYC+ treatment with the Telitacicept group
    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.
  • Active Comparator: glucocorticoids plus CYC and/or other immunosuppressants
    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.

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 ]

Central Contacts

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