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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

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
2,395 Previous Clinical Trials
17,341,345 Total Patients Enrolled

Media Library

Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04602598 — Phase 2
Related Disease Research Study Groups: Zanubrutinib
Related Disease Clinical Trial 2023: Zanubrutinib Highlights & Side Effects. Trial Name: NCT04602598 — Phase 2
Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04602598 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study currently being sought?

"Affirmative. According to clinicaltrials.gov, the trial is actively searching for subjects since its inception on August 1st 2022 and last update on October 24th 2022. The research requires 10 patients from a single medical centre."

Answered by AI

What is the scope of this research project in terms of participants?

"Affirmative. The information accessible on clinicaltrials.gov indicates that this medical inquiry, which was initially uploaded to the website on August 1st 2022, is actively seeking out participants. A total of 10 patients are required from a single site for successful enrollment."

Answered by AI

Has the FDA sanctioned Zanubrutinib 80 MG for general consumption?

"Our assessment of Zanubrutinib 80 MG's safety factor has been set to 2, as this Phase 2 trial only provides limited evidence of its security. There is currently no data proving the effectiveness of this medication."

Answered by AI

Has this kind of clinical trial ever been conducted before?

"Since its initial research in 2016, Zanubrutinib 80 MG has been approved by Phase 1 and is now under consideration for further clinical trials. MEI Pharma, Inc., initially sponsored the study with 177 participants; since then, 37 live studies have taken place across 324 cities and 32 countries worldwide."

Answered by AI

What criteria must a person fulfill in order to be eligible for this clinical research?

"To qualify for this clinical trial, individuals should have been diagnosed with immunoglobulin g4-related disease and must be between 18 to 85 years of age. The team is looking to recruit approximately 10 participants."

Answered by AI

What other investigations have taken place concerning Zanubrutinib 80 MG?

"Presently, 8 Phase 3 trials are researching the effects of Zanubrutinib 80 MG. While Palo Alto, California is one location with an active study for this drug, a total of 1104 sites have been deployed for research purposes."

Answered by AI

What medical applications does Zanubrutinib 80 MG typically have?

"The medication zanubrutinib 80 MG is often prescribed to those suffering from Waldenstrom macroglobulinemia. Additionally, it has been found to be effective in treating lymphoma and relapsed marginal zone lymphoma after one prior therapy session."

Answered by AI

Are people aged 30 and above eligible for this research endeavor?

"This clinical trial has an age range of 18-85 years old, with no exceptions."

Answered by AI
~2 spots leftby Dec 2024