Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIIB148, MOR202, MOR03087, TJ202, HIB202
Felzartamab · 12 trials · 12 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.
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Arm | Type | Description |
|---|---|---|
| Felzartamab: Long-Term Extension Treatment | EXPERIMENTAL | Participants will receive multiple IV doses of felzartamab. |
| Felzartamab: Off-Treatment Observation | EXPERIMENTAL | Participants who were off treatment but still continued participating in the respective parent study at the time of enrollment into the LTE or who have discontinued felzatamab treatment after receiving one or more doses in this substudy will be encouraged to continue being followed off-treatment. |
| 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. |
| MOR202 5 Doses | EXPERIMENTAL | 5 doses administered on Day 1, 8, 15, 29, and 57 |
| MOR202 2 Doses | EXPERIMENTAL | 2 doses administered on Day 1 and 15 |
| Cohort 1 (newly diagnosed or relapsed participants) | EXPERIMENTAL | Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
| Cohort 2 (refractory participants) | EXPERIMENTAL | Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
| Name | Type | Description |
|---|---|---|
| Felzartamab | DRUG | Administered IV |
| Tacrolimus | DRUG | Administered orally |
| Standard of Care IST | DRUG | Administered intravenously and orally |
| Placebo | DRUG | Administered IV |
| MOR202 | DRUG | MOR202 will be administered as an intravenous infusion |
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 monoclonal antibody being studied in immunology for several conditions, including antibody-mediated rejection and microvascular inflammation in kidney transplant recipients, Graves' disease, IgA nephropathy, and lupus nephritis. It has received Breakthrough Therapy designation from the FDA. It is not yet approved and remains in clinical development.
Felzartamab targets CD38, a protein found on the surface of certain immune cells. By binding CD38, felzartamab is designed to deplete those cells, which is the basis for its investigation in antibody-mediated and autoimmune conditions. It is classified as an inhibitor and is being developed as a monoclonal antibody therapy.
Felzartamab is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating felzartamab across immunology indications, including kidney transplant rejection, Graves' disease, and IgA nephropathy.
Felzartamab is in Phase 3 clinical development. The program includes Phase 3 trials in antibody-mediated rejection and microvascular inflammation in kidney transplant recipients and in primary membranous nephropathy, alongside Phase 2 studies in Graves' disease and late isolated microvascular inflammation. It is investigational and has not been approved by the FDA.
Felzartamab is being studied in several trials, including NCT07444489, a Phase 3 long-term safety study in kidney transplant recipients with antibody-mediated rejection or microvascular inflammation, and NCT06962800, a Phase 3 study in primary membranous nephropathy. Phase 2 trials include NCT07722546 in Graves' disease and NCT07219043 in late isolated microvascular inflammation.
Felzartamab is not FDA approved. It is an investigational monoclonal antibody still in clinical development, with Phase 3 trials ongoing. The FDA has granted it Breakthrough Therapy designation, a status intended to expedite development and review of drugs for serious conditions, but this designation does not constitute approval.