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Bruton's Tyrosine Kinase (BTK) Inhibitor
Zanubrutinib for Immunoglobulin-Related Disease
Phase 2
Recruiting
Research Sponsored by Matthew C. Baker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the lacrimal gland confirmed by international consensus pathology criteria
Men or women aged 18 to 85, inclusive, at the time of initial screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
Study Summary
This trial will test whether zanubrutinib is safe and effective in treating patients with a disease related to IgG4.
Who is the study for?
Adults aged 18-85 with confirmed IgG4-related disease affecting the submandibular or lacrimal glands can join. They must not be on certain immunosuppressants, except for a stable dose of prednisone. Women need a negative pregnancy test and agree to birth control use.Check my eligibility
What is being tested?
The trial is testing Zanubrutinib's safety and effectiveness in treating IgG4-related disease. Participants will receive an 80 mg dosage to assess how well it manages their condition compared to current standard treatments.See study design
What are the potential side effects?
Zanubrutinib may cause side effects such as bleeding problems, high blood pressure, infections due to low white blood cell count, irregular heartbeat, and possibly second primary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My IgG4-related disease in the salivary or tear glands is confirmed by a biopsy.
Select...
I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Volume of the lacrimal glands on PET-MRI
Volume of the submandibular glands on PET-MRI
Secondary outcome measures
FDG avidity (SUVmax) of the lacrimal glands on PET-MRI
FDG avidity (SUVmax) of the submandibular glands on PET-MRI
Trial Design
1Treatment groups
Experimental Treatment
Group I: ZanubrutinibExperimental Treatment1 Intervention
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
Find a Location
Who is running the clinical trial?
Matthew C. BakerLead Sponsor
1 Previous Clinical Trials
Stanford UniversityOTHER
2,408 Previous Clinical Trials
17,343,429 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken drugs like infliximab, abatacept, or tocilizumab in the last 56 days.I haven't taken BTK inhibitors in the last 6 months.I have not taken JAK inhibitor medication in the last 28 days.My IgG4-related disease in the salivary or tear glands is confirmed by a biopsy.I have an autoimmune disease that could affect study results, except for IgG4-related disease.I have had cancer before, but it was not skin, cervical, prostate, or colon cancer, or it was cured more than 5 years ago.I have not used B cell depleting therapy like rituximab in the last year.I am not on immunosuppressive drugs, except for prednisone or its equivalent, at a stable dose for the last 28 days.I do not have active tuberculosis, HIV, or hepatitis B/C.I haven't taken any strong immune or cancer drugs in the last 28 days.I am between 18 and 85 years old.I haven't taken any synthetic DMARDs like methotrexate in the last 28 days.My glucocorticoid dose has been stable for the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Zanubrutinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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