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 | - |
| 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. |
| 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. |
| 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...