Phase IIa, open label clinical trial of MOR202 in Anti-PLA2R aMN
Research type
Research Study
Full title
A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
IRAS ID
286877
Contact name
Durga Kanigicherla
Contact email
Sponsor organisation
MorphoSys AG
Eudract number
2020-002985-15
Duration of Study in the UK
2 years, 6 months, 7 days
Research summary
This is a Phase IIa open-label study to look at how safe and effective MOR202 is for treating membranous nephropathy. The purpose of the trial is to compare two different dosing regimen of the study drug MOR202 in patients with anti-PLA2R antibody-positive membranous nephropathy.
MOR202 belongs to a group of medicines called “monoclonal antibodies”, which are proteins designed to attach to the specific cells or substances in the body. MOR202 attaches to the antibody producing cells in the body and may diminish them. This way it decreases production of unwanted auto-antibodies which are considered responsible for the development and activity of membranous nephropathy.
The total duration of study participation is a little over 2 years from first screening assessment until the last visit.
The study participants will attend up to 20 study visits for up to 26 months starting with the screening period (up to 6 weeks), followed by the initial treatment period (3 months) and the follow-up period (3 months); a repeat treatment period (3 months) if necessary; and a final follow-up period (of 15 to18 months).
The study participants will be randomised 1:1 (50% chance) to two treatment arms (approximately 11 study participants per arm) to receive one of 2 dosing regimens of MOR202 (arm 1 and arm 2).
This trial treatment consists of a full treatment cycle which may be repeated once. No maintenance or follow up treatment with MOR202 is planned after the end of the trial.
This is a global study and it is being funded by MorphoSys AG.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0222
Date of REC Opinion
12 Oct 2020
REC opinion
Further Information Favourable Opinion