Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
25/06/2025
Titles & IDs
Public title
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Query!
Scientific title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Query!
Secondary ID [1]
0
0
2023-508290-81-00
Query!
Secondary ID [2]
0
0
VIB0551.P3.S2
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
IgG4 Related Disease
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
RCP: Time to Disease Flare
Query!
Assessment method [1]
0
0
Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).
Query!
Timepoint [1]
0
0
Up to Week 52
Query!
Secondary outcome [1]
0
0
RCP: Annualized Rate of Treated and AC-Determined Flares During the RCP
Query!
Assessment method [1]
0
0
The annualized rate of treated and AC-determined flares during the 52-week RCP was calculated by dividing the total number of treated and AC-determined flares by the total time at risk (in years) for all participants. This measure reflected the frequency of disease flares per person per year during the RCP.
Query!
Timepoint [1]
0
0
Week 52
Query!
Secondary outcome [2]
0
0
RCP: Percentage of Participants Achieving Flare-free, Treatment-free Complete Remission at Week 52
Query!
Assessment method [2]
0
0
Flare-free, treatment-free complete remission at Week 52 was defined as the absence of evident disease activity at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control, except for the required 8-week glucocorticoid taper. Lack of evident disease activity was determined by either a score of 0 on the IgG4-RD Responder Index (score range: 0-4, with lower scores indicating better disease control) or an investigator's assessment that no disease activity was present based on physical, laboratory, pathology, or other evidence.
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [3]
0
0
RCP: Percentage of Participants Achieving Flare-free, Corticosteroid-free Complete Remission at Week 52
Query!
Assessment method [3]
0
0
Flare-free, corticosteroid-free complete remission at Week 52 was defined as the absence of evident disease activity at Week 52, no AC-determined flare during the RCP, and no corticosteroid treatment for flare or disease control, except for the required 8-week glucocorticoid taper. Lack of evident disease activity was determined by either a score of 0 on the IgG4-RD Responder Index (score range: 0-4, with lower scores indicating better disease control) or an investigator's assessment that no disease activity was present based on physical, laboratory, pathology, or other evidence.
Query!
Timepoint [3]
0
0
Week 52
Query!
Secondary outcome [4]
0
0
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP
Query!
Assessment method [4]
0
0
An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious AEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the Common Terminology Criteria for Adverse Events \[CTCAE\]).
Query!
Timepoint [4]
0
0
Up to Week 52
Query!
Secondary outcome [5]
0
0
Number of Participants Who Experienced TEAEs During the OLP
Query!
Assessment method [5]
0
0
An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the CTCAE).
Query!
Timepoint [5]
0
0
From the first dose of investigational product in OLP to the end of OLP or cutoff date; median (min, max) duration was 51.6 (0.1, 108.3) weeks.
Query!
Secondary outcome [6]
0
0
RCP: Number of Participants With Anti-drug Antibodies (ADA) to Inebilizumab by Week 52
Query!
Assessment method [6]
0
0
Incidence was the proportion of the participants with ADA positive post-baseline only or boosted their preexisting ADA (at least 4-fold over the baseline titer) during the study period. Baseline was defined as the last valid value on or before the first dose of RCP.
Query!
Timepoint [6]
0
0
Baseline to Week 52
Query!
Secondary outcome [7]
0
0
RCP: Time to Initiation of First Treatment for New or Worsening Disease Activity Within the RCP
Query!
Assessment method [7]
0
0
Time to initiation of the first treatment (medication or procedure) for new or worsening disease activity, as determined by the investigator, within the RCP, was measured from day 1 (dosing) to the date the first treatment was administered. It Included any treatment initiated by the investigator for disease activity, regardless of the AC determination of flare. KM method was used to estimate the median time to the initiation of first treatment or worsening of disease activity, and 95% CI.
Query!
Timepoint [7]
0
0
Week 52
Query!
Secondary outcome [8]
0
0
RCP: Annualized Flare Rate for AC-Determined IgG4-RD Flares at Week 52
Query!
Assessment method [8]
0
0
The annualized flare rate for AC-determined IgG4-RD flares, whether or not treated, during the RCP was calculated by dividing the total number of AC-determined flares by the total time at risk (in years) for all participants. This measure reflected the frequency of IgG4-RD flares, irrespective of treatment, per participant per year during the study period.
Query!
Timepoint [8]
0
0
Week 52
Query!
Secondary outcome [9]
0
0
RCP: Cumulative Glucocorticoid (GC) Use for IgG4-RD Disease Control by Week 52
Query!
Assessment method [9]
0
0
GC use was calculated as the cumulative glucocorticoid dose (in milligrams) taken for the purpose of IgG4-RD disease control during the RCP. This measure accounted for all GC treatments administered to participants to manage disease activity throughout the study period.
Query!
Timepoint [9]
0
0
Week 52
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2028
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
135
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA
Query!
Recruitment hospital [1]
0
0
Viela Bio Investigative Site - Auchenflower
Query!
Recruitment hospital [2]
0
0
Viela Bio Investigative Site - Adelaide
Query!
Recruitment hospital [3]
0
0
Viela Bio Investigative Site - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
- Auchenflower
Query!
Recruitment postcode(s) [2]
0
0
- Adelaide
Query!
Recruitment postcode(s) [3]
0
0
- Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Georgia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
Argentina
Query!
State/province [5]
0
0
Buenos Aires
Query!
Country [6]
0
0
Argentina
Query!
State/province [6]
0
0
Mendoza
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Sherbrooke
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Toronto
Query!
Country [9]
0
0
China
Query!
State/province [9]
0
0
Inner Mongolia
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Beijing
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Guandong
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Shang'ai
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Shenyang
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Wuhan
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Clichy
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Lille
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Marseille
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Nantes
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Pessac
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Berlin
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Lübeck
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Muenchen
Query!
Country [23]
0
0
Hong Kong
Query!
State/province [23]
0
0
Hong Kong
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Debrecen
Query!
Country [25]
0
0
Hungary
Query!
State/province [25]
0
0
Szeged
Query!
Country [26]
0
0
India
Query!
State/province [26]
0
0
Bangalore
Query!
Country [27]
0
0
Ireland
Query!
State/province [27]
0
0
Cork
Query!
Country [28]
0
0
Israel
Query!
State/province [28]
0
0
Kfar Saba
Query!
Country [29]
0
0
Israel
Query!
State/province [29]
0
0
Petah tikva
Query!
Country [30]
0
0
Israel
Query!
State/province [30]
0
0
Tel Aviv
Query!
Country [31]
0
0
Israel
Query!
State/province [31]
0
0
Tel HaShomer
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Firenze
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Milano
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Pisa
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Reggio Emilia
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Torino
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Verona
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Fukuoka
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Hokkaido
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Hyogo
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Ishikawa
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Kyoto
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Niigata
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Osaka
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Tokyo
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Toyama
Query!
Country [47]
0
0
Mexico
Query!
State/province [47]
0
0
Tlalpan
Query!
Country [48]
0
0
Netherlands
Query!
State/province [48]
0
0
Amsterdam
Query!
Country [49]
0
0
Netherlands
Query!
State/province [49]
0
0
Rotterdam
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Warszawa
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Wroclaw
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Barcelona
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Madrid
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Valencia
Query!
Country [55]
0
0
Sweden
Query!
State/province [55]
0
0
Gothenburg
Query!
Country [56]
0
0
Sweden
Query!
State/province [56]
0
0
Stockholm
Query!
Country [57]
0
0
Turkey
Query!
State/province [57]
0
0
Ankara
Query!
Country [58]
0
0
Turkey
Query!
State/province [58]
0
0
Istanbul
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Leeds
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
London
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Newcastle
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04540497
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT04540497/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/97/NCT04540497/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04540497
Download to PDF