A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
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|ClinicalTrials.gov Identifier: NCT04540497|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : May 25, 2023
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|Condition or disease||Intervention/treatment||Phase|
|IgG4 Related Disease||Drug: Inebilizumab Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||October 2028|
Inebilizumab administered as an IV infusion.
Inebilizumab is a monoclonal antibody that depletes B cells.
Placebo Comparator: Placebo
Placebo administered as an IV infusion.
- Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and Adjudication Committee-determined IgG4 RD flare within the 52-week RCP. [ Time Frame: Day 1 to Day 365 ]
- Number of participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Day 2273 ]
- Number of participants with Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 2273 ]
- Number of participants with Treatment Emergent Adverse Events of Special Interest (TE AESIs) [ Time Frame: Day 1 to Day 2273 ]
- Number of Participants with positive Anti Drug Antibodies (ADAs) directed against inebilizumab [ Time Frame: Day 1 to Day 365 ]
- Annualized flare rate for treated flares [ Time Frame: Day 1 to Day 365 ]
- Annualized flare rate for Adjudication Committee (AC) determined flares [ Time Frame: Day 1 to Day 365 ]
- Annualized flare rate for AC-determined treated flares [ Time Frame: Day 1 to Day 365 ]
- Annualized flare rate for AC-determined untreated flares [ Time Frame: Day 1 to Day 365 ]
- Proportion of participants achieving flare-free complete remission [ Time Frame: Day 1 to Day 365 ]
- Time to initiation of first treatment for new or worsening disease activity [ Time Frame: Day 1 to Day 365 ]
- GC use for the purpose of IgG4-RD disease control [ Time Frame: Day 1 to Day 365 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540497
|Study Director:||Medical Director||Horizon Therapeutics Ireland DAC|
|Responsible Party:||Viela Bio (acquired by Horizon Therapeutics)|
|Other Study ID Numbers:||
2020-000417-33 ( EudraCT Number )
|First Posted:||September 7, 2020 Key Record Dates|
|Last Update Posted:||May 25, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Immunoglobulin G4-Related Disease
Immune System Diseases