Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Felzartamab · 9 trials · 7 indications
(Serious) adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA). Documentation of an AE will include the assessment of its relationship with the study drug (unrelated, related) and the severity of AE will be graded on a three-point scale (mild, moderate, severe).
Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria.
| Arm | Type | Description |
|---|---|---|
| Long-Term Extension: Felzartamab | EXPERIMENTAL | Participants will receive felzartamab, intravenously (IV), once every 8 weeks for up to 200 weeks in the LTE period. |
| Open-Label Treatment Phase | EXPERIMENTAL | Participants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase. |
| Non-Responder Treatment Phase | EXPERIMENTAL | Participants initially randomized to felzartamab or tacrolimus who meet rescue criteria may receive regional standard of care immunosuppressive therapy (IST) per Investigator discretion or several IV doses of felzartamab, respectively, in the Non-Responder Treatment Phase. |
| Cohort 1 | EXPERIMENTAL | Participants will receive several intravenous (IV) doses of felzartamab. |
| Cohort 2 | PLACEBO_COMPARATOR | Participants will receive several IV doses of placebo. |
| Cohort 3 | EXPERIMENTAL | 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. |
| Cohort 4 | PLACEBO_COMPARATOR | Participants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo. |
| Felzartamab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Felzartamab or Placebo | EXPERIMENTAL | Participants will receive multiple IV doses of felzartamab or placebo. |
| Placebo and Felzartamab | PLACEBO_COMPARATOR | Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141. |
| Part 1: Felzartamab Dosing Arm M1 | EXPERIMENTAL | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141. |
| Part 1: Felzartamab Dosing Arm M2 | EXPERIMENTAL | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
| Part 1: Felzartamab Dosing Arm M3 | EXPERIMENTAL | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| Part 2: Japan Cohort | EXPERIMENTAL | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| Name | Type | Description |
|---|---|---|
| Felzartamab | DRUG | Administered IV |
| Tacrolimus | DRUG | Administered orally |
| Standard of Care IST | DRUG | Administered intravenously and orally |
| Placebo | DRUG | Administered IV |
Key Inclusion Criteria: * Have completed the parent study Week 52 visit or will be completing Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit). * Have received at least one dose of felzartamab in the parent studies, and had the following disposition sta...
Felzartamab is an investigational small molecule being developed for multiple immunology indications, including Primary Membranous Nephropathy, Graves' Disease, Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis, and Microvascular Inflammation. It is also being studied in antibody-mediated rejection in kidney transplant recipients. The drug is currently in Phase 3 clinical development.
Felzartamab targets CD38, a protein expressed on plasma cells, and acts as an inhibitor. By inhibiting CD38, the drug is designed to modulate immune responses involved in various autoimmune and antibody-mediated conditions. This mechanism is being evaluated across multiple indications, including kidney transplant rejection and autoimmune nephropathies.
Felzartamab is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker BIIB. Biogen is conducting Phase 3 clinical trials for the drug across several indications, including antibody-mediated rejection and Primary Membranous Nephropathy.
Felzartamab is currently in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA. The drug is investigational and not yet approved for any indication. Multiple Phase 3 trials are ongoing or planned, including studies in kidney transplant rejection and Primary Membranous Nephropathy.
Felzartamab is being studied in several clinical trials. NCT05021484 is a completed Phase 2 trial in antibody-mediated rejection. NCT06685757 is an active Phase 3 trial in kidney transplant recipients with antibody-mediated rejection. NCT06962800 is a recruiting Phase 3 trial in Primary Membranous Nephropathy. NCT07444489 is a Phase 3 long-term extension study in antibody-mediated rejection or microvascular inflammation.
Felzartamab is also known by the ChEMBL identifier CHEMBL4594579. No other alternative names have been disclosed in the available information. The drug is a distinct investigational compound being developed by Biogen Inc. for multiple immunology indications.