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

IgG4 Related Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04540497
• Other study ID #: VIB0551.P3.S2
• Secondary ID: 2020-000417-33
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 26, 2020
• Est. completion date: October 2028

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: October 2028
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• IgG4 Related Disease

Intervention

Drug:
• Inebilizumab
Inebilizumab is a monoclonal antibody that depletes B cells.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Viela Bio Investigative Site	Buenos Aires
Argentina	Viela Bio Investigative Site	Mendoza
Australia	Viela Bio Investigative Site	Adelaide	South Australia
Australia	Viela Bio Investigative Site	Auchenflower	Queensland
Australia	Viela Bio Investigative Site	Fitzroy
Canada	Viela Bio Investigative Site	Sherbrooke
Canada	Viela Bio Investigative Site 1	Toronto
Canada	Viela Bio Investigative Site 2	Toronto
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	Beijing
China	Viela Bio Investigative Site	Guandong
China	Viela Bio Investigative Site	Hohhot	Inner Mongolia
China	Viela Bio Investigative Site	Shang'ai
China	Viela Bio Investigative Site	Shenyang
China	Viela Bio Investigative Site	Wuhan
France	Viela Bio Investigative Site	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
Germany	Viela Bio Investigative Site	Berlin
Germany	Viela Bio Investigative Site	Lübeck
Germany	Viela Bio Investigative Site	Muenchen
Hong Kong	Viela Bio Investigative Site	Hong Kong
Hungary	Viela Bio Investigative Site	Debrecen
Hungary	Viela Bio Investigative Site	Szeged
India	Viela Bio Investigative Site	Bangalore
Ireland	Viela Bio Investigative Site	Cork
Israel	Viela Bio Investigative Site	Kfar Saba
Israel	Viela Bio Investigative Site	Petah tikva
Israel	Viela Bio Investigative Site	Tel Aviv
Israel	Viela Bio Investigative Site	Tel HaShomer
Italy	Viela Bio Investigative Site	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
Japan	Viela Bio Investigative Site	Fukuoka
Japan	Viela Bio Investigative Site	Hokkaido
Japan	Viela Bio Investigative Site	Hyogo
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
Mexico	Viela Bio Investigative Siite	Tlalpan
Netherlands	Viela Bio Investigative Site	Amsterdam
Netherlands	Viela Bio Investigative Site	Rotterdam
Poland	Viela Bio Investigative Site	Warszawa
Poland	Viela Bio Investigative Site	Wroclaw
Spain	Viela Bio Investigative Site	Barcelona
Spain	Viela Bio Investigative Site 2	Barcelona
Spain	Viela Bio Investigative Site	Madrid
Spain	Viela Bio Investigative Site	Valencia
Sweden	Viela Bio Investigative Site	Gothenburg
Sweden	Viela Bio Investigative Site	Stockholm
Turkey	Viela Bio Investigative Site	Ankara
Turkey	Viela Bio Investigative Site	Istanbul
United Kingdom	Viela Bio Investigative Site	Leeds
United Kingdom	Viela Bio Investigative Site	London
United Kingdom	Viela Bio Investigative Site	Newcastle
United Kingdom	Viela Bio Investigative Site	Oxford
United States	Viela Bio Investigative Site	Atlanta	Georgia
United States	Viela Bio Investigative Site	Baltimore	Maryland
United States	Viela Bio Investigative Site	Boston	Massachusetts
United States	Viela Bio Investigative Site	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  France,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

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