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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04145440




Registration number
NCT04145440
Ethics application status
Date submitted
18/10/2019
Date registered
30/10/2019

Titles & IDs
Public title
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
Scientific title
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)
Secondary ID [1] 0 0
MOR202C103
Universal Trial Number (UTN)
Trial acronym
M-PLACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glomerulonephritis, Membranous 0 0
antiPLA2R Positive 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 - MOR202

Experimental: Cohort 1 - Patients with newly diagnosed or relapsed membranous nephropathy

Experimental: Cohort 2 - Patients with membranous nephropathy refractory to immunosuppressive treatment


Treatment: Drugs: MOR202
Patients will receive 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing will occur weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
safety and tolerability: incidence and severity of treatment-emergent adverse events
Timepoint [1] 0 0
at end of treatment phase (after 6 months)
Secondary outcome [1] 0 0
effect of MOR202 on serum anti-PLA2R antibodies
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
immunogenicity of MOR202
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
PK profile
Timepoint [3] 0 0
through study completion, an average of 1 year
Secondary outcome [4] 0 0
safety in the follow-up phase: incidence and severity of adverse events (AEs) in the follow-up phase
Timepoint [4] 0 0
through study completion, an average of 1 year

Eligibility
Key inclusion criteria
Key

* > 18 to < 80 years (at date of signing informed consent form [ICF]).
* Urine protein to creatinine ratio (UPCR) of = 3.000 g/g OR proteinuria = 3.500 g/24 h from 24-h urine at screening
* Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
* Estimated glomerular filtration rate = 50 ml/min/1.73m² or = 30 and <50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
* Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
* Systolic blood pressure BP =150 mmHg and diastolic BP =100 mmHg after 5 minutes of rest
* Vaccinated against Pneumococcus within the last 3 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
* Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies =50.0 RU/mL
* Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies = 20.0 RU/mL measured at screening

Note: France will only enroll patients in Cohort 2.

Key
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hemoglobin < 80 g/L.
* Thrombocytopenia: Platelets < 100.0 x 109/L.
* Neutropenia: Neutrophils < 1.5 x 109/L.
* Leukopenia: Leukocytes < 3.0 x 109/L.
* Hypogammaglobulinemia: Serum immunoglobulins = 4.0 g/L.

Subjects may receive supportive therapies to meet the above criteria

* B-cells < 5 x 106/L.
* Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
* Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
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
15/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2022
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. George Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Western Health - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Sydney
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
3021 - Melbourne
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Aalst
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Grenoble
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Saint-Priest-en-Jarez
Country [19] 0 0
Italy
State/province [19] 0 0
Firenze
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Italy
State/province [21] 0 0
Verona
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Daejeon
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Netherlands
State/province [24] 0 0
Nijmegen
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Poland
State/province [26] 0 0
Lódz
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Córdoba
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HI-Bio
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
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/NCT04145440