A Randomized, Double-blind, Placebo-controlled Trial of Efficacy and Safety of Low-dose Telitacicept for Prevention of Flares in SLE Patients With Low Disease Activity
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 18-70 years;
• SLE patients with low disease activity (SELENA-SLEDAI score\< 8 at screening ); disease duration more than 3 months；no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
• A stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months;
• Sign the informed consent.
Locations
Other Locations
China
Ren Ji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ting Li
leeting007@163.com
+8613916927066
Backup
Shuang Ye
ye_shuang2000@163.com
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 176
Treatments
Experimental: Telitacicept
Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.
Placebo_comparator: Placebo
Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital