A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
Purpose
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: - Participants will be screened to check if they can join the study. - Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. - Neither the researchers nor the participants will know what the participants will receive. - Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. - Afterwards, participants will enter a follow-up period which will last 80 weeks. - In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Condition
- Immunoglobulin A Nephropathy (IgAN)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF. - An eGFR ≥ 30 mL/min/1.73m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73m^2 is acceptable for the cohorts 3 and 4. - Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection. - Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN, and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using sparsentan will not be permitted to use simultaneous ACEI or ARB medication.
Exclusion Criteria
- Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator. - History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors. - Nephrotic syndrome presumed to be due to minimal change disease (MCD) variant. - Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy. - Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy). - Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants. - Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (> 7.5 milligrams per deciliter [mg/d] prednisone/prednisolone equivalent) within 4 months (or 12 months for rituximab) prior to Screening. - Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible. - Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded. - Hypogammaglobulinemia: Serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
Participants will receive several intravenous (IV) doses of felzartamab. |
|
|
Placebo Comparator Cohort 2 |
Participants will receive several IV doses of placebo. |
|
|
Experimental Cohort 3 |
Participants with an estimated glomerular filtration rate (eGFR) ≥ 20 and <30 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) will receive several IV doses of felzartamab. |
|
|
Placebo Comparator Cohort 4 |
Participants with an eGFR ≥ 20 and <30 mL/min/1.73m^2 will receive several IV doses of placebo. |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
501-804-5939
Apple Valley 5324363, California 5332921 92307
760-780-4179
Oxnard 5380184, California 5332921 93030
805-483-1185
San Dimas 5391891, California 5332921 91773
800-797-1695
Bradenton 4148708, Florida 4155751 34209
941-792-6564
Hollywood 4158928, Florida 4155751 33024
954-940-0208
Orlando 4167147, Florida 4155751 32806
407-472-5120
Acworth 4179074, Georgia 4197000 30101
470-227-8130
Pontiac 5006166, Michigan 5001836 48341
248-253-0330
The Bronx 5110266, New York 5128638 10468
71858490006099
Knoxville 4634946, Tennessee 4662168 37923-3624
692-3462
Dallas 4684888, Texas 4736286 95231
214-396-4950
Houston 4699066, Texas 4736286 77054
832-338-9118
Katy 4702732, Texas 4736286 77974
713-367-2791
San Juan 4568127, Puerto Rico 00927
(787) 763-7423
More Details
- Status
- Recruiting
- Sponsor
- Biogen
Detailed Description
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.