A Study of Telitacicept in Lupus Nephritis
ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.
About this trial
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
Eligibility criteria
Qualifiers
Males or females aged 18-75 years of age, inclusive.
Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).
Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility.
Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study's central laboratory results.
Disqualifiers
Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;
Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
Trial design
Treatments tested in this trial
- Telitacicept 240 mg
- Telitacicept 160 mg
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov