BridgeMD
New treatment option for Lupus Nephritis
Official title A Study of Telitacicept in Lupus Nephritis
ClinicalTrials.gov ID: NCT05680480
What this study is testing
What is Telitacicept 240 mg?
Telitacicept 240 mg is an investigational medicine, given as an once-weekly, being studied as a potential treatment for lupus nephritis.
Also referred to as RC18 240 mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Main
- 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...
- Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study\'s...
You likely can't join if
- 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.
- Received any of the following therapies:
- 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...
- Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
See the full eligibility criteria
- Main
- 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...
- 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.
- Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.
- Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when...
- Able to understand the requirements of the study and provide written informed consent. Main
- 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.
- Received any of the following therapies:
- 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...
- Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
- Received plasma separation or plasma exchange during the 6 weeks prior to screening;
- people who required dialysis within 1 year prior to screening.
- Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
- Received BCG Vaccine within 1 year prior to screening.
- History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of...
- History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
- Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in...
- Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
- History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
- Nursing or pregnant female, or male or female who prepared for parenthood during the study.
- History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
- Have acute or chronic infection requiring treatment.
- HIV positive.
- Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be...
- Hepatitis C antibody positive.
- History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.
- eGFR\<30 mL/min/1.73 m2 using CKD-EPI.
- Renal biopsy showed 50% glomerulosclerosis.
- Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables.
- people who in the opinion of the investigator are not suitable to participate.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Liuzhou, Guangxi, China
- Guiyang, Guizhou, China
- Baoding, Hebei, China
- Handan, Hebei, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Baotou, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Wuxi, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Xining, Qinghai, China
- Xi'an, Shaanxi, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Liuzhou, Guangxi, China and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.