Clinical Trials in Italy / NCT04540497
Active, not recruiting
Phase 3
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
NCT04540497 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
IgG4 Related Disease
Investigational drug(s) / intervention(s)
Inebilizumab →Placebo
Inebilizumab: Inebilizumab is a monoclonal antibody that depletes B cells.
Placebo: Placebo
Study summary
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
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.
Primary outcome measure(s)
- RCP: Time to Disease Flare — Up to Week 52
Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).
Trial sites (72)
| Facility | City | Region | Status |
|---|---|---|---|
| Viela Bio Investigative Site | Palo Alto | California | |
| Viela Bio Investigative Site | Atlanta | Georgia | |
| Viela Bio Investigative Site | Baltimore | Maryland | |
| Viela Bio Investigative Site | Boston | Massachusetts | |
| Viela Bio Investigative Site | Buenos Aires | Argentina | |
| Viela Bio Investigative Site | Mendoza | Argentina | |
| Viela Bio Investigative Site | Auchenflower | Queensland | |
| Viela Bio Investigative Site | Adelaide | South Australia | |
| Viela Bio Investigative Site | Fitzroy | Australia | |
| Viela Bio Investigative Site | Sherbrooke | Canada | |
| Viela Bio Investigative Site 1 | Toronto | Canada | |
| Viela Bio Investigative Site 2 | Toronto | Canada | |
| Viela Bio Investigative Site | Hohhot | Inner Mongolia | |
| 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 | Shang’ai | China | |
| Viela Bio Investigative Site | Shenyang | China | |
| Viela Bio Investigative Site | Wuhan | China | |
| 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 | France | |
| Viela Bio Investigative Site | Berlin | Germany | |
| Viela Bio Investigative Site | Lübeck | Germany | |
| Viela Bio Investigative Site | München | Germany | |
| Viela Bio Investigative Site | Hong Kong | Hong Kong | |
| Viela Bio Investigative Site | Debrecen | Hungary | |
| Viela Bio Investigative Site | Szeged | Hungary | |
| Viela Bio Investigative Site | Bangalore | India | |
| Viela Bio Investigative Site | Cork | Ireland | |
| 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 Litwinsky | Israel | |
| Viela Bio Investigative Site | Florence | Italy |
+ 32 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04540497 on ClinicalTrials.gov ↗ ← All trials in Italy