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Inebilizumab for IgG4-Related Disease
Study Summary
This trial will help researchers learn more about how well inebilizumab works to prevent flare-ups in IgG4-related disease, and if it is safe to use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 & 3 trial • 231 Patients • NCT02200770Trial Design
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Who is running the clinical trial?
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- My kidney function is severely reduced.I need steroids for my IgG4-related disease flare-up.I am using effective birth control as I could get pregnant.My IgG4-RD has affected at least two organs or sites.I haven't taken non-biologic DMARDs or immunosuppressants, except for GCs, in the last 4 weeks.I haven't had an active cancer except for certain types of cervical, skin, or prostate cancer in the last 10 years.I have not received a live vaccine or therapy with live agents in the last 2 weeks.I am a man who can father children and will use a condom with spermicide during the study and for 6 months after.I do not have active tuberculosis, hepatitis B, or untreated hepatitis C.I am 18 years old or older.I have been diagnosed with IgG4-related disease.I have had an organ transplant or have an immunodeficiency disorder.I haven't had B cell therapy in the last 6 months.
- Group 1: VIB0551
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any patients who have yet to enroll in this research study?
"The latest information from clinicaltrials.gov reports that this study is still recruiting patients. The trial was first posted on October 26th, 2020 and updated most recently on October 19th, 2022."
To the best of your knowledge, has there been extensive research on Inebilizumab in the past?
"At this time, there are 3 clinical trials underway that focus on Inebilizumab. Out of those 3, 2 are currently in Phase 3. Most studies related to Inebilizumab's efficacy are located in Lille Cedex, Utah; however,217 different locations worldwide are running trials for this medication."
What is the current standing of Inebilizumab in regards to federal approval?
"Our analysts at Power have Inebilizumab's safety rated as a 3. This is based on the fact that this medication is in Phase 3 trials, where there is both efficacy and safety data from multiple rounds of testing."
How many patients are enrolled in this clinical trial?
"In order to carry out the planned research, a total of 160 eligible patients are needed. The trial will be conducted by Viela Bio (now owned by Horizon Therapeutics) at various sites; two examples being Viela Bio Investigative Site 1 in Palo Alto, California and Viela Bio Investigative Site 2 situated in Baltimore, Maryland."
Have there been previous studies like this one?
"Research for inebilizumab began in 2020 with the earliest study being sponsored by Viela Bio. After the first Phase 3 trial, which included 270 people, the drug was approved. Now, there are three active studies taking place in 28 countries and 48 cities."
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