BION-1301 for IgA Nephropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
Will I have to stop taking my current medications?
The trial requires that participants with IgA Nephropathy be stable on their current dose of ACE inhibitors or ARBs for at least 3 months before joining. However, if you are taking systemic corticosteroids or other immunosuppressive therapies, you must stop these at least 3 months before starting the trial.
Is BION-1301 safe for humans?
How is the drug BION-1301 unique for treating IgA Nephropathy?
BION-1301 is unique because it is an anti-APRIL monoclonal antibody, which targets a specific protein involved in the immune response, potentially reducing the production of IgA antibodies that contribute to kidney damage in IgA Nephropathy. This mechanism is different from other treatments that may not specifically target this pathway.678910
What data supports the effectiveness of the drug BION-1301 for IgA Nephropathy?
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with IgA Nephropathy (IgAN) who have had a kidney biopsy in the last 10 years, protein in urine, and stable kidney function. They must be non-smokers, not pregnant or breastfeeding, not using drugs or alcohol excessively, and agree to use contraception. Healthy volunteers aged 18-55 with a BMI of 18-35 kg/m^2 can also participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Single Ascending Dose (SAD)
Double-blind, randomized, placebo-controlled, single ascending dose in healthy volunteers
Part 2: Multiple Ascending Dose (MAD)
Double-blind, randomized, placebo-controlled, multiple ascending dose in healthy volunteers
Part 3: Multiple Dose (MD)
Open-label, multiple dose in participants with IgA Nephropathy
Part 4: Retreatment
Eligible participants from Part 3 may enroll for optional retreatment due to disease progression or by choice
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BION-1301
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Chinook Therapeutics, Inc.
Lead Sponsor