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Trial record 1 of 1 for:    inebilizumab | IgG4 Related Disease
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A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540497
Recruitment Status : Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Viela Bio (acquired by Horizon Therapeutics)

Study Description
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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).

Condition or disease Intervention/treatment Phase
IgG4 Related Disease Drug: Inebilizumab Other: Placebo Phase 3

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : October 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VIB0551
Inebilizumab administered as an IV infusion.
 Drug: Inebilizumab
Inebilizumab is a monoclonal antibody that depletes B cells.
Placebo Comparator: Placebo
Placebo administered as an IV infusion.
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Number of participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Day 2273 ]
  2. Number of participants with Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 2273 ]
  3. Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs) [ Time Frame: Day 1 to Day 2273 ]
  4. Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab [ Time Frame: Day 1 to Day 365 ]
  5. Annualized flare rate for treated flares [ Time Frame: Day 1 to Day 365 ]
  6. Annualized flare rate for Adjudication Committee (AC) determined flares [ Time Frame: Day 1 to Day 365 ]
  7. Annualized flare rate for AC-determined treated flares [ Time Frame: Day 1 to Day 365 ]
  8. Annualized flare rate for AC-determined untreated flares [ Time Frame: Day 1 to Day 365 ]
  9. Proportion of participants achieving flare-free complete remission [ Time Frame: Day 1 to Day 365 ]
  10. Time to initiation of first treatment for new or worsening disease activity [ Time Frame: Day 1 to Day 365 ]
  11. GC use for the purpose of IgG4-RD disease control [ Time Frame: Day 1 to Day 365 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540497


Locations
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Sponsors and Collaborators
Viela Bio (acquired by Horizon Therapeutics)
Investigators
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Study Director: Medical Director Horizon Therapeutics Ireland DAC
More Information
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Responsible Party: Viela Bio (acquired by Horizon Therapeutics)
ClinicalTrials.gov Identifier: NCT04540497    
Other Study ID Numbers: VIB0551.P3.S2
2020-000417-33 ( EudraCT Number )
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunoglobulin G4-Related Disease
Autoimmune Diseases
Immune System Diseases