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

NCT04540497 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: VIB0551.P3.S22023-508290-81-00
• Study Type: interventional
• Target: 135
• Locations: 21 countries
• Sites: 72

Brief Summary

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

Conditions

IgG4 Related Disease

Outcome Measures

Primary Outcomes (1)

• RCP: Time to Disease Flare

  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).

  Up to Week 52

Secondary Outcomes (9)

• RCP: Annualized Rate of Treated and AC-Determined Flares During the RCP

  Week 52

• RCP: Percentage of Participants Achieving Flare-free, Treatment-free Complete Remission at Week 52

  Week 52

• RCP: Percentage of Participants Achieving Flare-free, Corticosteroid-free Complete Remission at Week 52

  Week 52

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP

  Up to Week 52

• Number of Participants Who Experienced TEAEs During the OLP

  From the first dose of investigational product in OLP to the end of OLP or cutoff date; median (min, max) duration was 51.6 (0.1, 108.3) weeks.

Study Arms (2)

VIB0551

EXPERIMENTAL

Inebilizumab administered as an IV infusion.

Drug: Inebilizumab

Placebo

PLACEBO COMPARATOR

Placebo administered as an IV infusion.

Other: Placebo

Interventions

Inebilizumab DRUG

Inebilizumab is a monoclonal antibody that depletes B cells.

VIB0551

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults, ≥ 18 years of age at time of informed consent.
• Clinical diagnosis of IgG4-RD.
• Fulfillment of the 2019 ACR/EULAR classification criteria.
• Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
• IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
• 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

You may not qualify if:

• History of solid organ or cell-based transplantation or known immunodeficiency disorder.
• 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).
• Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in the 6 months prior to screening.
• Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
• Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
• Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
• Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2.

Sponsors & Collaborators

• Amgen: lead

Study Sites (72)

Viela Bio Investigative Site

Palo Alto, California, 94305, United States

Location

Viela Bio Investigative Site

Atlanta, Georgia, 30322, United States

Location

Viela Bio Investigative Site

Baltimore, Maryland, 21287, United States

Location

Viela Bio Investigative Site

Boston, Massachusetts, 02114, United States

Location

Viela Bio Investigative Site

Buenos Aires, Argentina

Location

Viela Bio Investigative Site

Mendoza, Argentina

Location

Viela Bio Investigative Site

Auchenflower, Queensland, Australia

Location

Viela Bio Investigative Site

Adelaide, South Australia, Australia

Location

Viela Bio Investigative Site

Fitzroy, Australia

Location

Viela Bio Investigative Site

Sherbrooke, Canada

Location

Viela Bio Investigative Site 1

Toronto, Canada

Location

Viela Bio Investigative Site 2

Toronto, Canada

Location

Viela Bio Investigative Site

Hohhot, Inner Mongolia, China

Location

Viela Bio Investigative Site 1

Beijing, China

Location

Viela Bio Investigative Site 2

Beijing, China

Location

Viela Bio Investigative Site 3

Beijing, China

Location

Viela Bio Investigative Site 4

Beijing, China

Location

Viela Bio Investigative Site 5

Beijing, China

Location

Viela Bio Investigative Site

Guandong, China

Location

Viela Bio Investigative Site

Shang’ai, China

Location

Viela Bio Investigative Site

Shenyang, China

Location

Viela Bio Investigative Site

Wuhan, China

Location

Viela Bio Investigative Site

Clichy, France

Location

Viela Bio Investigative Site

Lille, France

Location

Viela Bio Investigative Site

Marseille, France

Location

Viela Bio Investigative Site

Nantes, France

Location

Viela Bio Investigative Site

Pessac, France

Location

Viela Bio Investigative Site

Berlin, Germany

Location

Viela Bio Investigative Site

Lübeck, Germany

Location

Viela Bio Investigative Site

München, Germany

Location

Viela Bio Investigative Site

Hong Kong, Hong Kong

Location

Viela Bio Investigative Site

Debrecen, Hungary

Location

Viela Bio Investigative Site

Szeged, Hungary

Location

Viela Bio Investigative Site

Bangalore, India

Location

Viela Bio Investigative Site

Cork, Ireland

Location

Viela Bio Investigative Site

Kfar Saba, Israel

Location

Viela Bio Investigative Site

Petah Tikva, Israel

Location

Viela Bio Investigative Site

Tel Aviv, Israel

Location

Viela Bio Investigative Site

Tel Litwinsky, Israel

Location

Viela Bio Investigative Site

Florence, Italy

Location

Viela Bio Investigative Site

Milan, Italy

Location

Viela Bio Investigative Site

Pisa, Italy

Location

Viela Bio Investigative Site

Reggio Emilia, Italy

Location

Viela Bio Investigative Site

Torino, Italy

Location

Viela Bio Investigative Site

Verona, Italy

Location

Viela Bio Investigative Site

Fukuoka, Japan

Location

Viela Bio Investigative Site

Hokkaido, Japan

Location

Viela Bio Investigative Site

Hyōgo, Japan

Location

Viela Bio Investigative Site

Ishikawa, Japan

Location

Viela Bio Investigative Site

Kyoto, Japan

Location

Viela Bio Investigative Site

Niigata, Japan

Location

Viela Bio Investigative Site 2

Osaka, Japan

Location

Viela Bio Investigative Site

Osaka, Japan

Location

Viela Bio Investigative Site

Tokyo, Japan

Location

Viela Bio Investigative Site

Toyama, Japan

Location

Viela Bio Investigative Siite

Tlalpan, Mexico

Location

Viela Bio Investigative Site

Amsterdam, Netherlands

Location

Viela Bio Investigative Site

Rotterdam, Netherlands

Location

Viela Bio Investigative Site

Warsaw, Poland

Location

Viela Bio Investigative Site

Wroclaw, Poland

Location

Viela Bio Investigative Site 2

Barcelona, Spain

Location

Viela Bio Investigative Site

Barcelona, Spain

Location

Viela Bio Investigative Site

Madrid, Spain

Location

Viela Bio Investigative Site

Valencia, Spain

Location

Viela Bio Investigative Site

Gothenburg, Sweden

Location

Viela Bio Investigative Site

Stockholm, Sweden

Location

Viela Bio Investigative Site

Ankara, Turkey (Türkiye)

Location

Viela Bio Investigative Site

Istanbul, Turkey (Türkiye)

Location

Viela Bio Investigative Site

Leeds, United Kingdom

Location

Viela Bio Investigative Site

London, United Kingdom

Location

Viela Bio Investigative Site

Newcastle, United Kingdom

Location

Viela Bio Investigative Site

Oxford, United Kingdom

Location

Related Publications (3)

• Tanaka Y, Umehara H, Sato H, Uchima K, Kouji K, Okazaki K. Inebilizumab treatment in Japanese patients with IgG4-related disease: a subgroup analysis of a randomized, double-blind, placebo-controlled, phase 3 trial (MITIGATE). Mod Rheumatol. 2026 Mar 6:roag020. doi: 10.1093/mr/roag020. Online ahead of print.

  PMID: 41786624 DERIVED

• Stone JH, Khosroshahi A, Zhang W, Della Torre E, Okazaki K, Tanaka Y, Lohr JM, Schleinitz N, Dong L, Umehara H, Lanzillotta M, Wallace ZS, Ebbo M, Webster GJ, Martinez Valle F, Nayar MK, Perugino CA, Rebours V, Dong X, Wu Y, Li Q, Rampal N, Cimbora D, Culver EL; MITIGATE Trial Investigators. Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. 2025 Mar 27;392(12):1168-1177. doi: 10.1056/NEJMoa2409712. Epub 2024 Nov 14.

  PMID: 39541094 DERIVED

• Perugino C, Culver EL, Khosroshahi A, Zhang W, Della-Torre E, Okazaki K, Tanaka Y, Lohr M, Schleinitz N, Falloon J, She D, Cimbora D, Stone JH. Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2023 Dec;10(6):1795-1808. doi: 10.1007/s40744-023-00593-7. Epub 2023 Oct 4.

  PMID: 37792260 DERIVED

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: December 4, 2020
• Primary Completion: April 9, 2024
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 11, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2); IN (1); IL (4); CA (3); ME (1); FR (5); NL (2); IE (1); HU (2); PL (2); TU (2); GB (4); HK (1); AU (3); SE (2); CN (10); IT (6); US (4); ES (4); JP (10); DE (3)