A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Primary Purpose
IgG4 Related Disease
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inebilizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for IgG4 Related Disease
Eligibility Criteria
Key Inclusion Criteria:
- Male or female adults, ≥ 18 years of age at time of informed consent.
- Clinical diagnosis of IgG4-RD.
- Fulfillment of the 2019 ACR/EULAR classification criteria.
- Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
- IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
- 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 Exclusion Criteria:
- History of solid organ or cell-based transplantation or known immunodeficiency disorder .
- 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).
- Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in prior 6 months
- Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
- Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
- Live vaccine or therapeutic agent in prior 2 weeks
- Glomerular filtration rate < 30 mL/min/1.73 m2
Sites / Locations
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site 1
- Viela Bio Investigative Site 2
- Viela Bio Investigative Site
- Viela Bio Investigative Site 1
- Viela Bio Investigative Site 2
- Viela Bio Investigative Site 3
- Viela Bio Investigative Site 4
- Viela Bio Investigative Site 5
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site 2
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Siite
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site 2
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
- Viela Bio Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VIB0551
Placebo
Arm Description
Inebilizumab administered as an IV infusion.
Placebo administered as an IV infusion.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Number of participants with Treatment Emergent Serious Adverse Events (TESAEs)
Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab
Annualized flare rate for treated flares
Annualized flare rate for Adjudication Committee (AC) determined flares
Annualized flare rate for AC-determined treated flares
Annualized flare rate for AC-determined untreated flares
Proportion of participants achieving flare-free complete remission
Time to initiation of first treatment for new or worsening disease activity
GC use for the purpose of IgG4-RD disease control
Full Information
NCT ID
NCT04540497
First Posted
September 1, 2020
Last Updated
October 17, 2023
Sponsor
Viela Bio (acquired by Horizon Therapeutics)
1. Study Identification
Unique Protocol Identification Number
NCT04540497
Brief Title
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Official Title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio (acquired by Horizon Therapeutics)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
Detailed Description
After a screening period of up to 28 days, subjects with IgG4-RD at high risk of flare due to multi-organ disease and recent active disease will be randomized in a 1:1 ratio to receive intravenous (IV) inebilizumab or placebo after premedication during the 52-week randomized control period (RCP). All subjects will receive an initial tapering dose of glucocorticoids (GCs) to complete treatment of their active disease. Flares occurring during study will be treated. The primary endpoint is time to a first adjudication committee-determined, investigator-treated disease flare during the RCP. The primary analysis will be conducted when the last subject completes the RCP visit or discontinues the RCP. This study includes an optional 3-year open-label treatment period. The study also includes a Safety Follow-up Period (SFUP) after IP discontinuation of up to 730 days. The expected duration of each subject's participation in this study is up to 400 days (screening and RCP), plus up to 1095 days for eligible subjects who enroll in the optional open label period (OLP), and up to 730 days for the SFUP after IP discontinuation, for a total maximum duration of up to 2273 days (screening, RCP, interval between RCP and OLP, OLP, and FSUP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4 Related Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VIB0551
Arm Type
Experimental
Arm Description
Inebilizumab administered as an IV infusion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Inebilizumab
Intervention Description
Inebilizumab is a monoclonal antibody that depletes B cells.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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.
Time Frame
Day 1 to Day 365
Secondary Outcome Measure Information:
Title
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Day 1 to Day 2273
Title
Number of participants with Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame
Day 1 to Day 2273
Title
Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Time Frame
Day 1 to Day 2273
Title
Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab
Time Frame
Day 1 to Day 365
Title
Annualized flare rate for treated flares
Time Frame
Day 1 to Day 365
Title
Annualized flare rate for Adjudication Committee (AC) determined flares
Time Frame
Day 1 to Day 365
Title
Annualized flare rate for AC-determined treated flares
Time Frame
Day 1 to Day 365
Title
Annualized flare rate for AC-determined untreated flares
Time Frame
Day 1 to Day 365
Title
Proportion of participants achieving flare-free complete remission
Time Frame
Day 1 to Day 365
Title
Time to initiation of first treatment for new or worsening disease activity
Time Frame
Day 1 to Day 365
Title
GC use for the purpose of IgG4-RD disease control
Time Frame
Day 1 to Day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female adults, ≥ 18 years of age at time of informed consent.
Clinical diagnosis of IgG4-RD.
Fulfillment of the 2019 ACR/EULAR classification criteria.
Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
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 Exclusion Criteria:
History of solid organ or cell-based transplantation or known immunodeficiency disorder.
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).
Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in the 6 months prior to screening.
Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
Estimated glomerular filtration rate < 30 mL/min/1.73 m^2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Horizon Therapeutics Ireland DAC
Official's Role
Study Director
Facility Information:
Facility Name
Viela Bio Investigative Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Viela Bio Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Viela Bio Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Viela Bio Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Viela Bio Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Viela Bio Investigative Site
City
Mendoza
Country
Argentina
Facility Name
Viela Bio Investigative Site
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
Viela Bio Investigative Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Viela Bio Investigative Site
City
Fitzroy
Country
Australia
Facility Name
Viela Bio Investigative Site
City
Sherbrooke
Country
Canada
Facility Name
Viela Bio Investigative Site 1
City
Toronto
Country
Canada
Facility Name
Viela Bio Investigative Site 2
City
Toronto
Country
Canada
Facility Name
Viela Bio Investigative Site
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
Viela Bio Investigative Site 1
City
Beijing
Country
China
Facility Name
Viela Bio Investigative Site 2
City
Beijing
Country
China
Facility Name
Viela Bio Investigative Site 3
City
Beijing
Country
China
Facility Name
Viela Bio Investigative Site 4
City
Beijing
Country
China
Facility Name
Viela Bio Investigative Site 5
City
Beijing
Country
China
Facility Name
Viela Bio Investigative Site
City
Guandong
Country
China
Facility Name
Viela Bio Investigative Site
City
Shang'ai
Country
China
Facility Name
Viela Bio Investigative Site
City
Shenyang
Country
China
Facility Name
Viela Bio Investigative Site
City
Wuhan
Country
China
Facility Name
Viela Bio Investigative Site
City
Clichy
Country
France
Facility Name
Viela Bio Investigative Site
City
Lille
Country
France
Facility Name
Viela Bio Investigative Site
City
Marseille
Country
France
Facility Name
Viela Bio Investigative Site
City
Nantes
Country
France
Facility Name
Viela Bio Investigative Site
City
Pessac
Country
France
Facility Name
Viela Bio Investigative Site
City
Berlin
Country
Germany
Facility Name
Viela Bio Investigative Site
City
Lübeck
Country
Germany
Facility Name
Viela Bio Investigative Site
City
Muenchen
Country
Germany
Facility Name
Viela Bio Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Viela Bio Investigative Site
City
Debrecen
Country
Hungary
Facility Name
Viela Bio Investigative Site
City
Szeged
Country
Hungary
Facility Name
Viela Bio Investigative Site
City
Bangalore
Country
India
Facility Name
Viela Bio Investigative Site
City
Cork
Country
Ireland
Facility Name
Viela Bio Investigative Site
City
Kfar Saba
Country
Israel
Facility Name
Viela Bio Investigative Site
City
Petah tikva
Country
Israel
Facility Name
Viela Bio Investigative Site
City
Tel Aviv
Country
Israel
Facility Name
Viela Bio Investigative Site
City
Tel HaShomer
Country
Israel
Facility Name
Viela Bio Investigative Site
City
Firenze
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Milano
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Pisa
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Reggio Emilia
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Torino
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Verona
Country
Italy
Facility Name
Viela Bio Investigative Site
City
Fukuoka
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Hokkaido
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Hyōgo
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Ishikawa
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Kyoto
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Niigata
Country
Japan
Facility Name
Viela Bio Investigative Site 2
City
Osaka
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Osaka
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Tokyo
Country
Japan
Facility Name
Viela Bio Investigative Site
City
Toyama
Country
Japan
Facility Name
Viela Bio Investigative Siite
City
Tlalpan
Country
Mexico
Facility Name
Viela Bio Investigative Site
City
Amsterdam
Country
Netherlands
Facility Name
Viela Bio Investigative Site
City
Rotterdam
Country
Netherlands
Facility Name
Viela Bio Investigative Site
City
Warszawa
Country
Poland
Facility Name
Viela Bio Investigative Site
City
Wrocław
Country
Poland
Facility Name
Viela Bio Investigative Site 2
City
Barcelona
Country
Spain
Facility Name
Viela Bio Investigative Site
City
Barcelona
Country
Spain
Facility Name
Viela Bio Investigative Site
City
Madrid
Country
Spain
Facility Name
Viela Bio Investigative Site
City
Valencia
Country
Spain
Facility Name
Viela Bio Investigative Site
City
Gothenburg
Country
Sweden
Facility Name
Viela Bio Investigative Site
City
Stockholm
Country
Sweden
Facility Name
Viela Bio Investigative Site
City
Ankara
Country
Turkey
Facility Name
Viela Bio Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Viela Bio Investigative Site
City
Leeds
Country
United Kingdom
Facility Name
Viela Bio Investigative Site
City
London
Country
United Kingdom
Facility Name
Viela Bio Investigative Site
City
Newcastle
Country
United Kingdom
Facility Name
Viela Bio Investigative Site
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
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