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-DE
• Lead Sponsor: Viela Bio, Inc./Horizon Therapeutics Ireland DAC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 8 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 the 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 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