Phase 2
N=54
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Immunoglobulin A (IgA) Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT05065970 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Apr 2026
Primary outcome: Primary: Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 — -24.7; -16.5; -30.6; -38.5 gram per gram (g/g) — p=0.6837
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Felzartamab (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HI-Bio, A Biogen Company
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 |
-24.7; -16.5; -30.6; -38.5 | 0.6837 |
| SECONDARY Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group |
-6.12; -14.1; -19.7; -26.1 | — |
| SECONDARY Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose |
445; 367 | — |
| SECONDARY Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 |
-18.0; -7.5; -35.1; -35.5; -12.8; -29.3 | — |
| SECONDARY Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 |
8.3; 9.1; 0; 44.4; 0; 9.1 | — |
| SECONDARY Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 |
1.278; 0.802; 0.841; 0.723; 1.053; 0.830 | — |
| SECONDARY Part 1: Duration of Response |
250; 140; 451; 188 | — |
| SECONDARY Part 1: Time to Response |
767; NA; NA; 176 | — |
| SECONDARY Change From Baseline in eGFR Over Time |
-1.985; 2.058; 8.100; 4.224; 1.011; -8.163 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) |
6; 10; 9; 11; 3; 0 | — |
| SECONDARY Serum Concentrations of Felzartamab Over Time |
67.9; 54.6; 50.0; 50.0; 204326.5; 320616.0 | — |
| SECONDARY Percentage of Participants With Anti- Felzartamab Antibodies |
1; 6; 3; 3; 1; 11 | — |
Summary
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
Eligibility Criteria
Key Inclusion Criteria
- Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country
- Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
- Proteinuria at screening visit ≥ 1.0 g/d.
- Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control.
- A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP
Key Exclusion Criteria
- Hemoglobin 1.5 x ULN, alkaline phosphatase >3.0 x ULN
Data sourced from ClinicalTrials.gov (NCT05065970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.