Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa and dose evaluation trial of Felzartamab in IgAN.

A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071210119

Enrollment

Registered

2022-01-23

Start date

2022-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Interventions

In the double-blind part of the trial, the IgA Nephropathy patients will be randomized to receive one of 3 different dosing schedules of MOR202 (dosing arms M1, M2 or M3) or placebo as 1:1:1:1, and be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients >=18 to ==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

Exclusion criteria

Exclusion criteria: -Hemoglobin 1.5 x ULN, alkaline phosphatase >3.0 x ULN

Design outcomes

Primary

Measure	Time frame
Relative change in UPCR in 24h urine at 9 months compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo.	—

Countries

Australia, Belgium, Bulgaria, Canada, Czech Republic, Georgia, Germany, Japan, Malaysia, Philippines, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, USA

Contacts

Public ContactMamiya Shinnosuke

PPDSNBL K.K

shinnosuke.mamiya@ppd.com+81-6-4560-6778

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026