A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Study Details
Study Description
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 |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Male or female adults, ≥ 18 years of age at time of informed consent.
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Clinical diagnosis of IgG4-RD.
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Fulfillment of the 2019 ACR/EULAR classification criteria.
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Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
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IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
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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:
-
History of solid organ or cell-based transplantation or known immunodeficiency disorder .
-
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).
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Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in prior 6 months
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Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
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Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
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Live vaccine or therapeutic agent in prior 2 weeks
-
Glomerular filtration rate < 30 mL/min/1.73 m2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Viela Bio Investigative Site | Palo Alto | California | United States | 94305 |
| 2 | Viela Bio Investigative Site | Atlanta | Georgia | United States | 30322 |
| 3 | Viela Bio Investigative Site | Baltimore | Maryland | United States | 21287 |
| 4 | Viela Bio Investigative Site | Boston | Massachusetts | United States | 02114 |
| 5 | Viela Bio Investigative Site | Columbus | Ohio | United States | 43210 |
| 6 | Viela Bio Investigative Site | Buenos Aires | Argentina | ||
| 7 | Viela Bio Investigative Site | Mendoza | Argentina | ||
| 8 | Viela Bio Investigative Site | Campbelltown | New South Wales | Australia | |
| 9 | Viela Bio Investigative Site | Auchenflower | Queensland | Australia | |
| 10 | Viela Bio Investigative Site | Adelaide | South Australia | Australia | |
| 11 | Viela Bio Investigative Site | Fitzroy | Australia | ||
| 12 | Viela Bio Investigative Site | Sherbrooke | Canada | ||
| 13 | Viela Bio Investigative Site 1 | Toronto | Canada | ||
| 14 | Viela Bio Investigative Site 2 | Toronto | Canada | ||
| 15 | Viela Bio Investigative Site | Hohhot | Inner Mongolia | China | |
| 16 | Viela Bio Investigative Site 1 | Beijing | China | ||
| 17 | Viela Bio Investigative Site 2 | Beijing | China | ||
| 18 | Viela Bio Investigative Site 3 | Beijing | China | ||
| 19 | Viela Bio Investigative Site 4 | Beijing | China | ||
| 20 | Viela Bio Investigative Site 5 | Beijing | China | ||
| 21 | Viela Bio Investigative Site | Guandong | China | ||
| 22 | Viela Bio Investigative Site | Shang'ai | China | ||
| 23 | Viela Bio Investigative Site | Shenyang | China | ||
| 24 | Viela Bio Investigative Site | Wuhan | China | ||
| 25 | Viela Bio Investigative Site | Clichy | France | ||
| 26 | Viela Bio Investigative Site | Lille | France | ||
| 27 | Viela Bio Investigative Site | Marseille | France | ||
| 28 | Viela Bio Investigative Site | Nantes | France | ||
| 29 | Viela Bio Investigative Site | Pessac | France | ||
| 30 | Viela Bio Investigative Site | Berlin | Germany | ||
| 31 | Viela Bio Investigative Site | Lübeck | Germany | ||
| 32 | Viela Bio Investigative Site | Muenchen | Germany | ||
| 33 | Viela Bio Investigative Site | Hong Kong | Hong Kong | ||
| 34 | Viela Bio Investigative Site | Debrecen | Hungary | ||
| 35 | Viela Bio Investigative Site | Szeged | Hungary | ||
| 36 | Viela Bio Investigative Site | Pune | Maharashtra | India | |
| 37 | Viela Bio Investigative Site | Hyderabad | Telangana | India | |
| 38 | Viela Bio Investigative Site | Bangalore | India | ||
| 39 | Viela Bio Investigative Site | Gurgaon | India | ||
| 40 | Viela Bio Investigative Site | Cork | Ireland | ||
| 41 | Viela Bio Investigative Site | Dublin | Ireland | ||
| 42 | Viela Bio Investigative Site | Kfar Saba | Israel | ||
| 43 | Viela Bio Investigative Site | Petah tikva | Israel | ||
| 44 | Viela Bio Investigative Site | Tel Aviv | Israel | ||
| 45 | Viela Bio Investigative Site | Tel HaShomer | Israel | ||
| 46 | Viela Bio Investigative Site | Firenze | Italy | ||
| 47 | Viela Bio Investigative Site | Milano | Italy | ||
| 48 | Viela Bio Investigative Site | Pisa | Italy | ||
| 49 | Viela Bio Investigative Site | Reggio Emilia | Italy | ||
| 50 | Viela Bio Investigative Site | Torino | Italy | ||
| 51 | Viela Bio Investigative Site | Verona | Italy | ||
| 52 | Viela Bio Investigative Site | Fukuoka | Japan | ||
| 53 | Viela Bio Investigative Site | Hokkaido | Japan | ||
| 54 | Viela Bio Investigative Site | Hyōgo | Japan | ||
| 55 | Viela Bio Investigative Site | Ishikawa | Japan | ||
| 56 | Viela Bio Investigative Site | Kyoto | Japan | ||
| 57 | Viela Bio Investigative Site | Niigata | Japan | ||
| 58 | Viela Bio Investigative Site 2 | Osaka | Japan | ||
| 59 | Viela Bio Investigative Site | Osaka | Japan | ||
| 60 | Viela Bio Investigative Site | Tokyo | Japan | ||
| 61 | Viela Bio Investigative Site | Toyama | Japan | ||
| 62 | Viela Bio Investigative Siite | Tlalpan | Mexico | ||
| 63 | Viela Bio Investigative Site | Amsterdam | Netherlands | ||
| 64 | Viela Bio Investigative Site | Nijmegen | Netherlands | ||
| 65 | Viela Bio Investigative Site | Rotterdam | Netherlands | ||
| 66 | Viela Bio Investigative Site | Warszawa | Poland | ||
| 67 | Viela Bio Investigative Site | Wrocław | Poland | ||
| 68 | Viela Bio Investigative Site 2 | Barcelona | Spain | ||
| 69 | Viela Bio Investigative Site | Barcelona | Spain | ||
| 70 | Viela Bio Investigative Site | Madrid | Spain | ||
| 71 | Viela Bio Investigative Site | Valencia | Spain | ||
| 72 | Viela Bio Investigative Site | Gothenburg | Sweden | ||
| 73 | Viela Bio Investigative Site | Stockholm | Sweden | ||
| 74 | Viela Bio Investigative Site | Ankara | Turkey | ||
| 75 | Viela Bio Investigative Site | Istanbul | Turkey | ||
| 76 | Viela Bio Investigative Site | Kharkiv | Ukraine | ||
| 77 | Viela Bio Investigative Site | Kherson | Ukraine | ||
| 78 | Viela Bio Investigative Site | Lviv | Ukraine | ||
| 79 | Viela Bio Investigative Site | Vinnytsia | Ukraine | ||
| 80 | Viela Bio Investigative Site | Leeds | United Kingdom | ||
| 81 | Viela Bio Investigative Site | London | United Kingdom | ||
| 82 | Viela Bio Investigative Site | Newcastle | United Kingdom | ||
| 83 | Viela Bio Investigative Site | Oxford | United Kingdom |
Sponsors and Collaborators
- Viela Bio (acquired by Horizon Therapeutics)
Investigators
- Study Director: Nishi Rampal, MD, Horizon Therapeutics Ireland DAC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIB0551.P3.S2
- 2020-000417-33