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A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease (VIB0551.P3.S2)

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease (VIB0551.P3.S2)

Cardona Ritsuko

Medpace Japan KK

1-5-8, Jingumae, Shibuya-ku, Tokyo

RSJapan1@medpace.com

Cardona Ritsuko

Medpace Japan KK

1-5-8, Jingumae, Shibuya-ku, Tokyo

+81-3-4563-7000

RSJapan1@medpace.com

Recruiting

Mar. 17, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male or female adults, greater than or equal to 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.

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 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

Both

IgG4-Related Disease

RCP: Blinded treatment on Day 1, Day 15, and Week 26:
- Inebilizumab group: Inebilizumab 300 mg intravenous (IV)
- Placebo group: IV placebo
Both groups: Oral prednisone (or equivalent) tablets from Day 1 to the end of Week 8 (tapering dose regimen: 2 weeks each at 20, 15, 10, and 5 mg/day of prednisone or equivalent, open-label, from commercial supply).

Optional OLP: Open-label inebilizumab 300 mg IV on Day 1; blinded inebilizumab 300 mg or matching placebo on Day 15 (depending on assigned RCP treatment), and then a single inebilizumab 300 mg IV infusion every 6 months for the duration of the OLP.

Time to disease flare, defined as the time in 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 is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.

+81-93-691-7503

Sept. 16, 2020

No

USA/China/Australia/Canada/France/Italy/Germay/Hong Kong/Hungary/Israel/Ireland/Mexico/Netherlands/Poland/Argentina/Spain/UK/Turkey/Ukraine/Sweden/India