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Clinical Trials in India / NCT04540497
Active, not recruiting Phase 3

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

NCT04540497 · tracked via the Priya Life Science India tracker
Sponsor
Amgen
Phase
Phase 3
Started
2020-12-04
Last updated
2025-12-11

Condition(s) studied

IgG4 Related Disease

Investigational drug(s) / intervention(s)

InebilizumabPlacebo

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

Sex
ALL
Min age
18 Years
Max age
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 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)

Trial sites (72)

FacilityCityRegionStatus
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.

More Amgen trials in India

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 India