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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05065970




Registration number
NCT05065970
Ethics application status
Date submitted
14/09/2021
Date registered
4/10/2021

Titles & IDs
Public title
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Scientific 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
Secondary ID [1] 0 0
MOR202C206
Universal Trial Number (UTN)
Trial acronym
IGNAZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A (IgA) Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Felzartamab
Other interventions - Placebo

Placebo comparator: Placebo -

Experimental: Felzartamab Arm #1 -

Experimental: Felzartamab Arm #2 -

Experimental: Felzartamab Arm #3 -


Treatment: Drugs: Felzartamab
anti-CD38+ monoclonal antibody

Other interventions: Placebo
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: Relative change in Proteinuria value
Timepoint [1] 0 0
9 months compared to baseline
Secondary outcome [1] 0 0
Safety: determined by the frequency, incidence and severity of TEAEs
Timepoint [1] 0 0
Ongoing through study completion, up to 2 years
Secondary outcome [2] 0 0
Efficacy: Relative change in proteinuria value
Timepoint [2] 0 0
Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Secondary outcome [3] 0 0
Efficacy: complete response in patients with IgAN
Timepoint [3] 0 0
Ongoing through treatment completion, an average every 3 months per treatment period, up to 2 years
Secondary outcome [4] 0 0
Pharmacokinetic: serum concentrations of Felzartamab over time
Timepoint [4] 0 0
Ongoing through treatment completion, up to 2 years

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2024
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Core Research Group - Milton
Recruitment hospital [2] 0 0
Sunshine Hospital - Australia - Saint Albans
Recruitment postcode(s) [1] 0 0
4064 - Milton
Recruitment postcode(s) [2] 0 0
- Saint Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerpen
Country [5] 0 0
Belgium
State/province [5] 0 0
Vlaams Brabant
Country [6] 0 0
Belgium
State/province [6] 0 0
Ieper
Country [7] 0 0
Belgium
State/province [7] 0 0
Liège
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia-Grad
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Montana
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Plovdiv
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Stara Zagora
Country [12] 0 0
Czechia
State/province [12] 0 0
Moravskoslezský Kraj
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomoucký Kraj
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha, Hlavní Mesto
Country [15] 0 0
Georgia
State/province [15] 0 0
Tbilisi
Country [16] 0 0
Germany
State/province [16] 0 0
Niedersachsen
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalen
Country [18] 0 0
Germany
State/province [18] 0 0
Mainz
Country [19] 0 0
Japan
State/province [19] 0 0
Hokkaidô
Country [20] 0 0
Japan
State/province [20] 0 0
Hukuoka
Country [21] 0 0
Japan
State/province [21] 0 0
Hukusima
Country [22] 0 0
Japan
State/province [22] 0 0
Miyagi
Country [23] 0 0
Japan
State/province [23] 0 0
Tiba
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
Japan
State/province [25] 0 0
Totigi
Country [26] 0 0
Japan
State/province [26] 0 0
Ôsaka
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gyeonggido
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul Teugbyeolsi
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Uijeongbu-Si
Country [30] 0 0
Malaysia
State/province [30] 0 0
Pantai
Country [31] 0 0
Philippines
State/province [31] 0 0
Batangas
Country [32] 0 0
Serbia
State/province [32] 0 0
Vojvodina
Country [33] 0 0
Serbia
State/province [33] 0 0
Belgrade
Country [34] 0 0
Serbia
State/province [34] 0 0
Krusevac
Country [35] 0 0
Serbia
State/province [35] 0 0
Nis
Country [36] 0 0
Spain
State/province [36] 0 0
Badalona
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Girona
Country [39] 0 0
Spain
State/province [39] 0 0
Lleida
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Taiwan
State/province [41] 0 0
New Taipei City
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
Ukraine
State/province [44] 0 0
Ternopil's'ka Oblast
Country [45] 0 0
Ukraine
State/province [45] 0 0
Kyiv
Country [46] 0 0
Ukraine
State/province [46] 0 0
Zaporizhzhia
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HI-Bio, A Biogen Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
HI-Bio Clinical Program Lead
Address 0 0
HI-Bio, A Biogen Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05065970