A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

March 19, 2024 updated by: Amgen

A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 acquired from Horizon in 2024.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Viela Bio Investigative Site
      • Mendoza, Argentina
        • Viela Bio Investigative Site
  • Australia
      • Fitzroy, Australia
        • Viela Bio Investigative Site
    • Queensland
      • Auchenflower, Queensland, Australia
        • Viela Bio Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Viela Bio Investigative Site
  • Canada
      • Sherbrooke, Canada
        • Viela Bio Investigative Site
      • Toronto, Canada
        • Viela Bio Investigative Site 1
      • Toronto, Canada
        • Viela Bio Investigative Site 2
  • China
      • Beijing, China
        • Viela Bio Investigative Site 1
      • Beijing, China
        • Viela Bio Investigative Site 2
      • Beijing, China
        • Viela Bio Investigative Site 3
      • Beijing, China
        • Viela Bio Investigative Site 4
      • Beijing, China
        • Viela Bio Investigative Site 5
      • Guandong, China
        • Viela Bio Investigative Site
      • Shang'ai, China
        • Viela Bio Investigative Site
      • Shenyang, China
        • Viela Bio Investigative Site
      • Wuhan, China
        • Viela Bio Investigative Site
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Viela Bio Investigative Site
  • France
      • Clichy, France
        • Viela Bio Investigative Site
      • Lille, France
        • Viela Bio Investigative Site
      • Marseille, France
        • Viela Bio Investigative Site
      • Nantes, France
        • Viela Bio Investigative Site
      • Pessac, France
        • Viela Bio Investigative Site
  • Germany
      • Berlin, Germany
        • Viela Bio Investigative Site
      • Lübeck, Germany
        • Viela Bio Investigative Site
      • Muenchen, Germany
        • Viela Bio Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Viela Bio Investigative Site
  • Hungary
      • Debrecen, Hungary
        • Viela Bio Investigative Site
      • Szeged, Hungary
        • Viela Bio Investigative Site
  • India
      • Bangalore, India
        • Viela Bio Investigative Site
  • Ireland
      • Cork, Ireland
        • Viela Bio Investigative Site
  • Israel
      • Kfar Saba, Israel
        • Viela Bio Investigative Site
      • Petah tikva, Israel
        • Viela Bio Investigative Site
      • Tel Aviv, Israel
        • Viela Bio Investigative Site
      • Tel HaShomer, Israel
        • Viela Bio Investigative Site
  • Italy
      • Firenze, Italy
        • Viela Bio Investigative Site
      • Milano, Italy
        • Viela Bio Investigative Site
      • Pisa, Italy
        • Viela Bio Investigative Site
      • Reggio Emilia, Italy
        • Viela Bio Investigative Site
      • Torino, Italy
        • Viela Bio Investigative Site
      • Verona, Italy
        • Viela Bio Investigative Site
  • Japan
      • Fukuoka, Japan
        • Viela Bio Investigative Site
      • Hokkaido, Japan
        • Viela Bio Investigative Site
      • Hyōgo, Japan
        • Viela Bio Investigative Site
      • Ishikawa, Japan
        • Viela Bio Investigative Site
      • Kyoto, Japan
        • Viela Bio Investigative Site
      • Niigata, Japan
        • Viela Bio Investigative Site
      • Osaka, Japan
        • Viela Bio Investigative Site 2
      • Osaka, Japan
        • Viela Bio Investigative Site
      • Tokyo, Japan
        • Viela Bio Investigative Site
      • Toyama, Japan
        • Viela Bio Investigative Site
  • Mexico
      • Tlalpan, Mexico
        • Viela Bio Investigative Siite
  • Netherlands
      • Amsterdam, Netherlands
        • Viela Bio Investigative Site
      • Rotterdam, Netherlands
        • Viela Bio Investigative Site
  • Poland
      • Warszawa, Poland
        • Viela Bio Investigative Site
      • Wrocław, Poland
        • Viela Bio Investigative Site
  • Spain
      • Barcelona, Spain
        • Viela Bio Investigative Site
      • Barcelona, Spain
        • Viela Bio Investigative Site 2
      • Madrid, Spain
        • Viela Bio Investigative Site
      • Valencia, Spain
        • Viela Bio Investigative Site
  • Sweden
      • Gothenburg, Sweden
        • Viela Bio Investigative Site
      • Stockholm, Sweden
        • Viela Bio Investigative Site
  • Turkey
      • Ankara, Turkey
        • Viela Bio Investigative Site
      • Istanbul, Turkey
        • Viela Bio Investigative Site
  • United Kingdom
      • Leeds, United Kingdom
        • Viela Bio Investigative Site
      • London, United Kingdom
        • Viela Bio Investigative Site
      • Newcastle, United Kingdom
        • Viela Bio Investigative Site
      • Oxford, United Kingdom
        • Viela Bio Investigative Site
  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Viela Bio Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Viela Bio Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Viela Bio Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Viela Bio Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 to Day 365

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIB0551.P3.S2
  • 2020-000417-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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