Immunoglobulin A Nephropathy
Conditions
Keywords
Felzartamab, Biopsy
Brief summary
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. The main goal of the study is to learn about the effect felzartamab has on the buildup of IgA clusters in the kidneys. The main question that researchers want to answer is: • How much does the buildup of IgA in the kidney change from the start of the study to Week 36? Researchers will also learn about the effect felzartamab has on kidney health by measuring protein levels in the urine and the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how the body processes the drug. The study will be done as follows: * Participants will be screened to check if they can join the study. * This is an open-label study, which means both the researchers and the participants will know that all participants are receiving felzartamab. * Participants will receive felzartamab as intravenous (IV) infusions. * Participants will have kidney biopsies done over the course of the study to help measure changes in the health of the kidneys. * Participants will have multiple scheduled study visits over about 104 weeks. An extra study visit may be needed if a participant decides to leave the study early. * In total, participants will stay in the study for about 2 years (up to 112 weeks).
Detailed description
The primary objective of the study is to evaluate the effects of felzartamab on immunoglobulin A (IgA) deposition by immunofluorescence (IF). The secondary objectives are to evaluate the effects of felzartamab on histological and efficacy endpoints, and to evaluate the safety, pharmacokinetics (PK), and immunogenicity of felzartamab.
Interventions
DRUGFelzartamab
Administered IV
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Biopsy-confirmed diagnosis of IgAN. Key
Exclusion criteria
* Conditions that may predispose to an increased bleeding risk, as determined by the Investigator. * History of diabetes mellitus. * Any diagnosed or suspected immunosuppressed or immunodeficient state. * Any history of malignancy within 5 years prior to Screening with the exception of adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or other non-melanomatous skin cancer. * Any clinically significant underlying illness that, in the opinion of the Investigator, medical monitor, and/or Sponsor may compromise study participation, present a safety risk to the participant, or may confound the interpretation of the study results, including general non-adherence to study medication therapy. * Active clinically significant infections; known history of recurrent clinically significant infection. * Hematologic and hepatic abnormalities. * History of major surgery, severe trauma, or bone fracture within 3 months prior to first dose of felzartamab or planned major surgery any time from Screening until 1 month after the end of study. Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mesangial Immunoglobulin A (IgA) Deposition by Immunofluorescence (IF) | Baseline, Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Mesangial IgA Deposition by IF | Baseline, Week 104 |
| Percent Change From Baseline in Proteinuria | Baseline up to Week 36 |
| Annualized Rate of Change (slope) in the Estimated Glomerular Filtration Rate (eGFR) | Baseline up to Week 104 |
| Change From Baseline in eGFR | Baseline up to Week 104 |
| Percentage of Participants Achieving Complete Response (CR) | Baseline up to Week 104 |
| Percentage of Participants who Progressed to Kidney Failure | Baseline up to Week 104 |
| Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | Baseline up to Week 104 |
| Number of Participants with Clinically Significant Laboratory, Physical Examination, Vital Signs and Electrocardiograms (ECGs) Abnormalities | Baseline up to Week 104 |
| Felzartamab Serum Concentrations Over Time | Predose and at multiple timepoints postdose up to Week 36 |
| Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab | Baseline up to Week 104 |
Contacts
CONTACTUS Biogen Clinical Trial Center
CONTACTGlobal Biogen Clinical Trial Center
STUDY_DIRECTORMedical Director
Biogen
Outcome results
None listed