Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

Sponsor
Beijing Hospital
Study ID
NCT05998759
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    subcutaneous telitacicept 160 mg weekly for 24 weeks.
  • Placebo — DRUG
    subcutaneous placebo weekly for 24 weeks.

Study Details

The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.

Key Dates

Start date
Dec 2, 2023
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
296 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept plus standard therapy
    Telitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).
  • Placebo Comparator: Placebo plus standard therapy
    Placebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).

Primary Outcome Measure

Overall response (CR + PR) rate [ Time Frame: at week 24 ]

Central Contacts

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