Zanubrutinib for Immunoglobulin-Related Disease
MC
AR
Overseen ByAngie R Aberia, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Matthew C. Baker
Must be taking: Glucocorticoids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease
Eligibility Criteria
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.Inclusion Criteria
All women must test negative for pregnancy and agree to use a reliable method of birth control
Presence of a lymphoplasmacytic infiltrate with 10 IgG4+ plasma cells per high-power field and/or an IgG4+/IgG+ plasma cell ratio of 40%
My IgG4-related disease in the salivary or tear glands is confirmed by a biopsy.
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Exclusion 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.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive zanubrutinib orally at a dose of 80mg BID for 24 weeks
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Zanubrutinib
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ZanubrutinibExperimental Treatment1 Intervention
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
Zanubrutinib is already approved in United States, China for the following indications:
Approved in United States as Brukinsa for:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
Approved in China as Brukinsa for:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew C. Baker
Lead Sponsor
Trials
2
Recruited
10+
Stanford University
Collaborator
Trials
2,527
Recruited
17,430,000+
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