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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Telitacicept 240 mg
Biological/VaccineParticipants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
Telitacicept 160 mg
Biological/VaccineParticipants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
Placebo
DrugParticipants will receive placebo weekly in addition to SOC for 48 weeks.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Telitacicept 240 mgExperimental treatment 1 intervention
Group B: Telitacicept 160 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with Complete Renal Response (CRR)
CRR is defined as estimated glomerular filtration rate (GFR) is no more than 20% below the baseline value or ≥ 60 mL/min/1.73m\^2 and 24-hour urinary protein: creatinine ratio ≤ 0.5 mg/mg and did not receive prohibited or rescue therapy resulting in treatment failure.
Time frame
Week 48Secondary outcomes
1
Percentage of participants with Partial Renal Response (PRR)
PRR is defined as 24-hour urinary protein: creatinine ratio reduced by 50% compared to baseline value.
Time frame
Week 24 and Week 482
Incidence of AE, SAE
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose resulting in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment.
Time frame
Up to Week 48Sponsors and contacts
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Source ClinicalTrials.gov