IGNAZ

• Research type

  Research Study

• Full title

  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 - IGNAZ

• IRAS ID

  1003200

• Contact name

• Sponsor organisation

  MorphoSys AG

• Eudract number

  2020-005054-19

• Research summary

  All patients will receive angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers–the supportive standard of care therapy - throughout the trial. Patients will be randomized to receive one of 3 different dosing schedules of Felzartamab or placebo.Approximately 44 patients will be randomized in this trial with 11 patients per dosing arm (including placebo).All patients will follow the clinical trial schedule consisting of a Screening Phase(up to 6 weeks),Treatment Phase(6 months),Follow-up Phase(18 months).Patients will attend 17 trial visits. A patient is considered to have completed the trial if she/he has completed all applicable phases of the trial.Felzartamab belongs to a group of medicines called “monoclonal antibodies”, proteins designed to attach to specific cells or substances in the body.Felzartamab attaches to the antibody producing cells in the body and may diminish them. This way it decreases production of unwanted auto-antibodies considered responsible for the development of IgA nephropathy.If the patient agrees to take part in this study, the patient will be assigned randomly (this means by chance, like flipping a coin) to receive either:Treatment arm 1: 2 doses of Felzartamab at Day 1 and 15, and additionally 7 doses of placebo at Day 8, 22, 29, 57, 85, 113 and 141,Treatment arm 2: 5 doses of Felzartamab at Day 1, 8, 15, 29 and 57, and additionally 4 doses of placebo at Day 22, 85, 113 and 141,Treatment arm 3: 9 doses of Felzartamab at Day 1, 8, 15, 22, 29, 57, 85, 113 and 141,Treatment arm 4: 9 doses of placebo at Day 1, 8, 15, 22, 29, 57, 85, 113 and 141.The patient will have a 1 in 4 chance of receiving either one of the three different doses of Felzartamab in combination with placebo or placebo alone. Neither the patient nor the study doctor can choose the treatment group.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0229

• Date of REC Opinion

  18 May 2021

• REC opinion

  Further Information Favourable Opinion