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

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

Tracking Information
First Submitted Date  ICMJE September 14, 2021
First Posted Date  ICMJE October 4, 2021
Last Update Posted Date December 13, 2022
Actual Study Start Date  ICMJE August 31, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
Efficacy: Relative change in Proteinuria value [ Time Frame: 9 months compared to baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Immunoglobulin A (IgA) Nephropathy
Intervention  ICMJE
  • Drug: Felzartamab
    anti-CD38+ monoclonal antibody
    Other Name: MOR202
  • Other: Placebo
    Placebo comparator
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2021)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Morphosys Clinical Program Lead +498989927 ext 0 MOR202C206-CPL@morphosys.com
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Czechia,   Georgia,   Germany,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Serbia,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05065970
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party MorphoSys AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MorphoSys AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MorphoSys AG
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP