Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy (IGNAZ)

• ClinicalTrials.gov Identifier: NCT05065970
• Recruitment Status: Recruiting
• First Posted: October 4, 2021
• Last Update Posted: December 13, 2022
• Sponsor: MorphoSys AG
• Information provided by (Responsible Party): MorphoSys AG

Tracking Information

• First Submitted Date: September 14, 2021
• First Posted Date: October 4, 2021
• Last Update Posted Date: December 13, 2022
• Actual Study Start Date: August 31, 2021
• Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 23, 2021): Efficacy: Relative change in Proteinuria value [ Time Frame: 9 months compared to baseline ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 23, 2021)

• Safety: determined by the frequency, incidence and severity of TEAEs [ Time Frame: Ongoing through study completion, up to 2 years ]
• Efficacy: Relative change in proteinuria value [ Time Frame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years ]
• Efficacy: complete response in patients with IgAN [ Time Frame: Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years ]
• Pharmacokinetic: serum concentrations of Felzartamab over time [ Time Frame: Ongoing through treatment completion, up to 2 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
• Official 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
• Brief Summary: Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Immunoglobulin A (IgA) Nephropathy

Intervention

• Drug: Felzartamab
  anti-CD38+ monoclonal antibody
  Other Name: MOR202
• Other: Placebo
  Placebo comparator

Study Arms

• Placebo Comparator: Placebo
  Intervention: Other: Placebo
• Experimental: Felzartamab Arm #1
  Intervention: Drug: Felzartamab
• Experimental: Felzartamab Arm #2
  Intervention: Drug: Felzartamab
• Experimental: Felzartamab Arm #3
  Intervention: Drug: Felzartamab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 23, 2021): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)

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 < 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Morphosys Clinical Program Lead; +498989927 ext 0; MOR202C206-CPL@morphosys.com

• Listed Location Countries: Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Korea, Republic of, Malaysia, Philippines, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States

Administrative Information

• NCT Number: NCT05065970
• Other Study ID Numbers: MOR202C206
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: MorphoSys AG
• Original Responsible Party: Same as current
• Current Study Sponsor: MorphoSys AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: MorphoSys AG
• Verification Date: December 2022