Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04540497
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : April 7, 2022
Information provided by (Responsible Party):
Viela Bio (acquired by Horizon Therapeutics)

Brief Summary:
This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-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 52-week open-label treatment period. The expected duration of each subject's participation in this study is up to 400 days (screening and RCP) or, for eligible subjects who enroll in the optional OLP, up to 813 days (screening, RCP, interval between RCP and OLP, and OLP).

Layout table for study information
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: Prevention
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 : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

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 identifier (NCT number): NCT04540497

Layout table for location contacts
Contact: Horizon Therapeutics 1-866-479-6742

Show Show 83 study locations
Sponsors and Collaborators
Viela Bio (acquired by Horizon Therapeutics)
Layout table for investigator information
Study Director: Nishi Rampal, MD Horizon Therapeutics Ireland DAC
Layout table for additonal information
Responsible Party: Viela Bio (acquired by Horizon Therapeutics) 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: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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