Clinical trial NCT04540497: A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: IgG4 Related Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Day 1 to Day 365
Secondary outcomes:
measure: Number of participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 2273
measure: Number of participants with Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Day 2273
measure: Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs)
timeFrame: Day 1 to Day 2273
measure: Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab
timeFrame: Day 1 to Day 365
measure: Annualized flare rate for treated flares
timeFrame: Day 1 to Day 365
measure: Annualized flare rate for Adjudication Committee (AC) determined flares
timeFrame: Day 1 to Day 365
measure: Annualized flare rate for AC-determined treated flares
timeFrame: Day 1 to Day 365
measure: Annualized flare rate for AC-determined untreated flares
timeFrame: Day 1 to Day 365
measure: Proportion of participants achieving flare-free complete remission
timeFrame: Day 1 to Day 365
measure: Time to initiation of first treatment for new or worsening disease activity
timeFrame: Day 1 to Day 365
measure: GC use for the purpose of IgG4-RD disease control
timeFrame: Day 1 to Day 365
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Viela Bio Investigative Site
state: California
city: Atlanta
country: United States
facility: Viela Bio Investigative Site
state: Georgia
city: Baltimore
country: United States
facility: Viela Bio Investigative Site
state: Maryland
city: Boston
country: United States
facility: Viela Bio Investigative Site
state: Massachusetts
city: Buenos Aires
country: Argentina
facility: Viela Bio Investigative Site
city: Mendoza
country: Argentina
facility: Viela Bio Investigative Site
city: Auchenflower
country: Australia
facility: Viela Bio Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Viela Bio Investigative Site
state: South Australia
city: Fitzroy
country: Australia
facility: Viela Bio Investigative Site
city: Sherbrooke
country: Canada
facility: Viela Bio Investigative Site
city: Toronto
country: Canada
facility: Viela Bio Investigative Site 1
city: Toronto
country: Canada
facility: Viela Bio Investigative Site 2
city: Hohhot
country: China
facility: Viela Bio Investigative Site
state: Inner Mongolia
city: Beijing
country: China
facility: Viela Bio Investigative Site 1
city: Beijing
country: China
facility: Viela Bio Investigative Site 2
city: Beijing
country: China
facility: Viela Bio Investigative Site 3
city: Beijing
country: China
facility: Viela Bio Investigative Site 4
city: Beijing
country: China
facility: Viela Bio Investigative Site 5
city: Guandong
country: China
facility: Viela Bio Investigative Site
city: Shang'ai
country: China
facility: Viela Bio Investigative Site
city: Shenyang
country: China
facility: Viela Bio Investigative Site
city: Wuhan
country: China
facility: Viela Bio Investigative Site
city: Clichy
country: France
facility: Viela Bio Investigative Site
city: Lille
country: France
facility: Viela Bio Investigative Site
city: Marseille
country: France
facility: Viela Bio Investigative Site
city: Nantes
country: France
facility: Viela Bio Investigative Site
city: Pessac
country: France
facility: Viela Bio Investigative Site
city: Berlin
country: Germany
facility: Viela Bio Investigative Site
city: Lübeck
country: Germany
facility: Viela Bio Investigative Site
city: Muenchen
country: Germany
facility: Viela Bio Investigative Site
city: Hong Kong
country: Hong Kong
facility: Viela Bio Investigative Site
city: Debrecen
country: Hungary
facility: Viela Bio Investigative Site
city: Szeged
country: Hungary
facility: Viela Bio Investigative Site
city: Bangalore
country: India
facility: Viela Bio Investigative Site
city: Cork
country: Ireland
facility: Viela Bio Investigative Site
city: Kfar Saba
country: Israel
facility: Viela Bio Investigative Site
city: Petah tikva
country: Israel
facility: Viela Bio Investigative Site
city: Tel Aviv
country: Israel
facility: Viela Bio Investigative Site
city: Tel HaShomer
country: Israel
facility: Viela Bio Investigative Site
city: Firenze
country: Italy
facility: Viela Bio Investigative Site
city: Milano
country: Italy
facility: Viela Bio Investigative Site
city: Pisa
country: Italy
facility: Viela Bio Investigative Site
city: Reggio Emilia
country: Italy
facility: Viela Bio Investigative Site
city: Torino
country: Italy
facility: Viela Bio Investigative Site
city: Verona
country: Italy
facility: Viela Bio Investigative Site
city: Fukuoka
country: Japan
facility: Viela Bio Investigative Site
city: Hokkaido
country: Japan
facility: Viela Bio Investigative Site
city: Hyōgo
country: Japan
facility: Viela Bio Investigative Site
city: Ishikawa
country: Japan
facility: Viela Bio Investigative Site
city: Kyoto
country: Japan
facility: Viela Bio Investigative Site
city: Niigata
country: Japan
facility: Viela Bio Investigative Site
city: Osaka
country: Japan
facility: Viela Bio Investigative Site 2
city: Osaka
country: Japan
facility: Viela Bio Investigative Site
city: Tokyo
country: Japan
facility: Viela Bio Investigative Site
city: Toyama
country: Japan
facility: Viela Bio Investigative Site
city: Tlalpan
country: Mexico
facility: Viela Bio Investigative Siite
city: Amsterdam
country: Netherlands
facility: Viela Bio Investigative Site
city: Rotterdam
country: Netherlands
facility: Viela Bio Investigative Site
city: Warszawa
country: Poland
facility: Viela Bio Investigative Site
city: Wrocław
country: Poland
facility: Viela Bio Investigative Site
city: Barcelona
country: Spain
facility: Viela Bio Investigative Site 2
city: Barcelona
country: Spain
facility: Viela Bio Investigative Site
city: Madrid
country: Spain
facility: Viela Bio Investigative Site
city: Valencia
country: Spain
facility: Viela Bio Investigative Site
city: Gothenburg
country: Sweden
facility: Viela Bio Investigative Site
city: Stockholm
country: Sweden
facility: Viela Bio Investigative Site
city: Ankara
country: Turkey
facility: Viela Bio Investigative Site
city: Istanbul
country: Turkey
facility: Viela Bio Investigative Site
city: Leeds
country: United Kingdom
facility: Viela Bio Investigative Site
city: London
country: United Kingdom
facility: Viela Bio Investigative Site
city: Newcastle
country: United Kingdom
facility: Viela Bio Investigative Site
city: Oxford
country: United Kingdom
facility: Viela Bio Investigative Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: