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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04540497




Registration number
NCT04540497
Ethics application status
Date submitted
1/09/2020
Date registered
7/09/2020

Titles & IDs
Public title
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Scientific title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Secondary ID [1] 0 0
2020-000417-33
Secondary ID [2] 0 0
VIB0551.P3.S2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgG4 Related Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

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

Experimental: VIB0551 - Inebilizumab administered as an IV infusion.

Placebo comparator: Placebo - Placebo administered as an IV infusion.


Treatment: Drugs: Inebilizumab
Inebilizumab is a monoclonal antibody that depletes B cells.

Other interventions: Placebo
Placebo
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
Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and Adjudication Committee-determined IgG4 RD flare within the 52-week RCP.
Timepoint [1] 0 0
Day 1 to Day 365
Secondary outcome [1] 0 0
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 to Day 2273
Secondary outcome [2] 0 0
Number of participants with Treatment Emergent Serious Adverse Events (TESAEs)
Timepoint [2] 0 0
Day 1 to Day 2273
Secondary outcome [3] 0 0
Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Timepoint [3] 0 0
Day 1 to Day 2273
Secondary outcome [4] 0 0
Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab
Timepoint [4] 0 0
Day 1 to Day 365
Secondary outcome [5] 0 0
Annualized flare rate for treated flares
Timepoint [5] 0 0
Day 1 to Day 365
Secondary outcome [6] 0 0
Annualized flare rate for Adjudication Committee (AC) determined flares
Timepoint [6] 0 0
Day 1 to Day 365
Secondary outcome [7] 0 0
Annualized flare rate for AC-determined treated flares
Timepoint [7] 0 0
Day 1 to Day 365
Secondary outcome [8] 0 0
Annualized flare rate for AC-determined untreated flares
Timepoint [8] 0 0
Day 1 to Day 365
Secondary outcome [9] 0 0
Proportion of participants achieving flare-free complete remission
Timepoint [9] 0 0
Day 1 to Day 365
Secondary outcome [10] 0 0
Time to initiation of first treatment for new or worsening disease activity
Timepoint [10] 0 0
Day 1 to Day 365
Secondary outcome [11] 0 0
GC use for the purpose of IgG4-RD disease control
Timepoint [11] 0 0
Day 1 to Day 365

Eligibility
Key inclusion criteria
Key

1. Male or female adults, = 18 years of age at time of informed consent.
2. Clinical diagnosis of IgG4-RD.
3. Fulfillment of the 2019 ACR/EULAR classification criteria.
4. Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
5. IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
6. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of solid organ or cell-based transplantation or known immunodeficiency disorder.
2. Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin or prostate cancer are acceptable).
3. Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in the 6 months prior to screening.
4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
5. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
6. Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
7. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Viela Bio Investigative Site - Auchenflower
Recruitment hospital [2] 0 0
Viela Bio Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Viela Bio Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Fitzroy
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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Mendoza
Country [7] 0 0
Canada
State/province [7] 0 0
Sherbrooke
Country [8] 0 0
Canada
State/province [8] 0 0
Toronto
Country [9] 0 0
China
State/province [9] 0 0
Inner Mongolia
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Guandong
Country [12] 0 0
China
State/province [12] 0 0
Shang'ai
Country [13] 0 0
China
State/province [13] 0 0
Shenyang
Country [14] 0 0
China
State/province [14] 0 0
Wuhan
Country [15] 0 0
France
State/province [15] 0 0
Clichy
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Nantes
Country [19] 0 0
France
State/province [19] 0 0
Pessac
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Lübeck
Country [22] 0 0
Germany
State/province [22] 0 0
Muenchen
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Hong Kong
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Szeged
Country [26] 0 0
India
State/province [26] 0 0
Bangalore
Country [27] 0 0
Ireland
State/province [27] 0 0
Cork
Country [28] 0 0
Israel
State/province [28] 0 0
Kfar Saba
Country [29] 0 0
Israel
State/province [29] 0 0
Petah tikva
Country [30] 0 0
Israel
State/province [30] 0 0
Tel Aviv
Country [31] 0 0
Israel
State/province [31] 0 0
Tel HaShomer
Country [32] 0 0
Italy
State/province [32] 0 0
Firenze
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Pisa
Country [35] 0 0
Italy
State/province [35] 0 0
Reggio Emilia
Country [36] 0 0
Italy
State/province [36] 0 0
Torino
Country [37] 0 0
Italy
State/province [37] 0 0
Verona
Country [38] 0 0
Japan
State/province [38] 0 0
Fukuoka
Country [39] 0 0
Japan
State/province [39] 0 0
Hokkaido
Country [40] 0 0
Japan
State/province [40] 0 0
Hyogo
Country [41] 0 0
Japan
State/province [41] 0 0
Ishikawa
Country [42] 0 0
Japan
State/province [42] 0 0
Kyoto
Country [43] 0 0
Japan
State/province [43] 0 0
Niigata
Country [44] 0 0
Japan
State/province [44] 0 0
Osaka
Country [45] 0 0
Japan
State/province [45] 0 0
Tokyo
Country [46] 0 0
Japan
State/province [46] 0 0
Toyama
Country [47] 0 0
Mexico
State/province [47] 0 0
Tlalpan
Country [48] 0 0
Netherlands
State/province [48] 0 0
Amsterdam
Country [49] 0 0
Netherlands
State/province [49] 0 0
Rotterdam
Country [50] 0 0
Poland
State/province [50] 0 0
Warszawa
Country [51] 0 0
Poland
State/province [51] 0 0
Wroclaw
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Valencia
Country [55] 0 0
Sweden
State/province [55] 0 0
Gothenburg
Country [56] 0 0
Sweden
State/province [56] 0 0
Stockholm
Country [57] 0 0
Turkey
State/province [57] 0 0
Ankara
Country [58] 0 0
Turkey
State/province [58] 0 0
Istanbul
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Leeds
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Newcastle
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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)?
No
No/undecided IPD sharing reason/comment


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/NCT04540497