Inebilizumab efficacy and safety in IgG4 related disease

Phase 1

• Conditions: Immunoglobulin G4-related disease (IgG4-RD); MedDRA version: 20.0Level: PTClassification code 10077271Term: Immunoglobulin G4 related diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-000417-33-NL
• Lead Sponsor: Viela Bio, Inc./Horizon Therapeutics Ireland DAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-29
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Male or female adults who have reached the age of consent in the applicable region (eg, =18 years in the US).
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. One organ must meet the requirements for the ACR/EULAR
classification criteria; the second organ is as defined by the investigator.
6.Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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, prostate or thyroid cancer are acceptable).
3.Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in prior 6 months
4.Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks
5.Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
6.Live vaccine or therapeutic agent in prior 2 weeks
7.Glomerular filtration rate < 30 mL/min/1.73 m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified