This study will have two parts. The main aims are to: * check the side effects from mezagitamab. * check for long-term side effects from mezagitamab. Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period. Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.
The drug being tested in this study is called mezagitamab. Mezagitamab is being tested for the first time in this patient population and might help to treat people who have Primary Immunoglobulin (IgA) Nephropathy. This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mezagitamab in combination with stable background therapy. The study will enroll approximately 16 participants. The study will consist of 2 key components: a main study and a long-term extension (LTE) study, which includes an observation period and a retreatment period. The observation period of the LTE study is a non-interventional study segment and the retreatment period of the LTE study consists of a redosing period in which participants will be administered mezagitamab at the same dose level as in the main study. Only participants who have a positive outcome during the main study will enter LTE study. Participants will be enrolled to the following cohort: • Mezagitamab This multi-center trial will be conducted in the United States, Europe, and Asia Pacific. The overall time to participate in this study is approximately 154 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
TAK-079 subcutaneous injection.
Amicis Research Center - Northridge - Nordhoff
Northridge, California, United States
Boise Kidney and Hypertension Institute - Frenova
Nampa, Idaho, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Core Research Group
Milton, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, Hungary
...and 16 more locations
Main Study: Percentage of Participants With one or More Treatment-emergent Adverse Events (TEAEs), Grade 3 or Higher TEAEs, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Mezagitamab Discontinuation
The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: Up to Week 48
LTE Observation Period: Percentage of Participants With one or More TEAEs, Grade 3 or Higher TEAEs and SAEs
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
Time frame: Up to Week 96
LTE Retreatment Period: Percentage of Participants With one or More TEAEs, SAEs, Grade 3 or Higher TEAEs and AEs leading to Mezagitamab Discontinuation
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
Time frame: Retreatment Week 0 to 48
Main Study: Ctrough: Observed Serum Trough Concentrations of Mezagitamab
Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)
Main Study: Serum IgA Levels
Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)
Main Study: Percent Change From Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR)
UPCR is calculated by dividing the concentration of protein (milligram per deciliter \[mg/dL\]) in urine by the urine creatinine concentration (mg/dL).
Time frame: Week 36
Main Study: Percentage of Participants Based on Antidrug Antibody (ADA) Levels in Serum
Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study.
Time frame: Up to Week 48
LTE Observation Period: Serum IgA Levels
Time frame: Week 56 Pre-dose and at multiple time points (up to Week 96)
LTE Observation Period: Percent Change From Baseline in Proteinuria Based on UPCR
UPCR is calculated by dividing the concentration of protein (mg/dL) in urine by the urine creatinine concentration (mg/dL).
Time frame: Up to Week 96
LTE Observation Period: Percentage of Participants Based on ADA Levels in Serum
Time frame: Up to Week 96
LTE Retreatment Period: Percentage of Participants Based on ADA Levels in Serum
Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study.
Time frame: Up to Retreatment Week 48
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