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

JRCT ID: jRCT2071210119

Registered date:23/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: IgA Nephropathy
• Date of first enrollment: 17/01/2022
• Target sample size: 8
• Countries of recruitment: Germany,Japan,Belgium,Japan,USA,Japan,Australia,Japan,South Korea,Japan,Serbia,Japan,Spain,Japan,Malaysia,Japan,Georgia,Japan,Czech Republic,Japan,Canada,Japan,Philippines,Japan,Taiwan,Japan,United Kingdom,Japan,Ukraine,Japan,Bulgaria,Japan
• Study type: Interventional
• Intervention(s): 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 administered for 6 months. The absolute dose to be administered intravenously (i.v.) will be determined according to body weight of the patient. The patients in open label part of the trial will receive MOR202 according to M3 schedule.

Outcome(s)

• Primary Outcome: Relative change in UPCR in 24h urine at 9 months compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude criteria

-Hemoglobin < 90 g/L
-Thrombocytopenia: Platelets < 100.0 x 10^9/L.
-Neutropenia: Neutrophils < 1.5 x 10^9/L.
-Leukopenia: Leukocytes < 3.0 x 10^9/L
-Diabetes mellitus type 1
-Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN

Related Information

• Primary Sponsor: Shinnosuke Mamiya
• Secondary ID(s): NCT05065970,2020-005054-19