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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04540497
Ethics application status
Date submitted
1/09/2020
Date registered
7/09/2020
Date last updated
5/04/2021

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

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
Gender
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 prior 6 months

4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4
weeks

5. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of
curative treatment; evidence of hepatitis B infection

6. Live vaccine or therapeutic agent in prior 2 weeks

7. Glomerular filtration rate < 30 mL/min/1.73 m2

Study design
Purpose of the study
Prevention
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Viela Bio Investigative Site - Campbelltown
Recruitment hospital [2] 0 0
Viela Bio Investigative Site - Auchenflower
Recruitment hospital [3] 0 0
Viela Bio Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Viela Bio Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- 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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
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United States of America
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Massachusetts
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United States of America
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Ohio
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Canada
State/province [8] 0 0
Sherbrooke
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Canada
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Toronto
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China
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Inner Mongolia
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China
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Beijing
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China
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Guandong
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China
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Shang'ai
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China
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Shenyang
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China
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Wuhan
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France
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Clichy
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France
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Lille
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France
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Marseille
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France
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Nantes
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France
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Pessac
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Germany
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Berlin
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Germany
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Muenchen
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Hong Kong
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Hong Kong
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Hungary
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Debrecen
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Hungary
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Szeged
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India
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Maharashtra
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India
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Telangana
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India
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Bangalore
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India
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Gurgaon
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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Kfar Saba
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Israel
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Petah tikva
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Israel
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Tel Aviv
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Israel
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Tel HaShomer
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Italy
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Firenze
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Italy
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Milano
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Torino
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Italy
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Verona
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kyoto
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Toyama
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Mexico
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Tlalpan
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Netherlands
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Amsterdam
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Barcelona
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Madrid
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Spain
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Valencia
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Gothenburg
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Sweden
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Stockholm
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Turkey
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Ankara
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Istanbul
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Ukraine
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Kharkiv
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Kherson
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Vinnytsia
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Ukraine
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Zaporizhzhya
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Leeds
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Manchester
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Newcastle
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Viela Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to define the efficacy and safety of inebilizumab for the prevention of flare
of IgG4-related disease (IgG4-RD).
Trial website
https://clinicaltrials.gov/show/NCT04540497
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Judith Falloon, MD
Address 0 0
Viela Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director, MD
Address 0 0
Country 0 0
Phone 0 0
+1 240-454-6266
Fax 0 0
Email 0 0
clinicaltrials@vielabio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04540497