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| Name | Class |
|---|---|
| Stanford University | OTHER |
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The aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with IgG4-related disease
This will be a single-site, open-label study in symptomatic patients with IgG4-related disease affecting the submandibular and/or lacrimal glands. All patients will receive zanubrutinib orally at a dose of 80mg BID for 24 weeks.
The primary objective of this study is to demonstrate that zanubrutinib treatment reduces reduces the volume of the submandibular and/or lacrimal glands on PET/MRI at week 24 compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib | Experimental | Zanubrutinib orally at a dose of 80mg BID for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib 80 MG | Drug | Zanubrutinib 80 MG for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of the Submandibular Glands on PET-MRI | To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at week 24 compared to Baseline. | Baseline and Week 24 |
| Volume of the Lacrimal Glands on PET-MRI | To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| FDG Avidity (SUVmax) of the Submandibular Glands on PET | Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET at Weeks 12 and 24 compared to Baseline. | Baseline, Week 12, and Week 24 |
| FDG Avidity (SUVmax) of the Lacrimal Glands on PET |
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Inclusion Criteria:
Men or women aged 18 to 85, inclusive, at the time of initial screening
Have histopathologically confirmed IgG4-RD in the submandibular gland and/or the lacrimal gland confirmed by international consensus pathology criteria
All women must test negative for pregnancy and agree to use a reliable method of birth control
No current treatment with immunosuppressive medications other than prednisone 40mg daily (or other glucocorticoid equivalent) with stable dosing for 28 days
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zanubrutinib | Zanubrutinib orally at a dose of 80mg BID for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zanubrutinib | Zanubrutinib orally at a dose of 80mg BID for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of the Submandibular Glands on PET-MRI | To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at week 24 compared to Baseline. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 24. | Posted | Mean | Standard Deviation | cm^3 | Baseline and Week 24 |
|
|
Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zanubrutinib | Zanubrutinib orally at a dose of 80mg BID for 24 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Baker | Stanford University, School of Medicine, Division of Immunology & Rheumatology | 6504970744 | mbake13@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2025 | Jan 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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Open-label study in symptomatic subjects with histopathologically confirmed IgG4-related disease affecting the submandibular and/or lacrimal glands. Ten subjects will be included in the study. All eligible subjects will receive zanubrutinib 80mg BID over a period of 24 weeks and will be followed up for an additional 8 weeks after the last dose.
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Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET at Week 24 compared to Baseline. |
| Baseline, Week 12, and Week 24 |
| Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET | Baseline, Week 12, and Week 24 |
| Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET | Baseline, Week 12, and Week 24 |
| Change in Submandibular Glands on MRI | Change in parenchymal architecture scored 0 to 4 and sialography scored 0 to 4 where 0 is normal, healthy gland and 4 is worse outcome. | Baseline, Week 12, and Week 24 |
| Change in Parotid Glands on MRI | Change in parenchymal architecture scored 0 to 4 and sialography scored 0 to 4, where 0 is normal, healthy gland and 4 is worse outcome. | Baseline, Week 12, and Week 24 |
| Change in Lacrimal Glands on MRI | Change in parenchymal architecture scored 0 to 4, where 0 is normal, healthy gland and 4 is worse outcome. | Baseline, Week 12, and Week 24 |
| Change in the Volume of the Parotid Glands on PET/MRI | Baseline, Week 12, and Week 24 |
| Change in the Volume of the Submandibular Glands on PET/MRI | Baseline and Week 12 |
| Change in the Volume of the Lacrimal Glands on PET/MRI | Baseline, and Week 12 |
| Change in Serum IgG4 Level | Baseline, Week 12, and Week 24 |
| Change in Plasmablast Count | Change in percentage of CD19+ B cells in blood | Baseline, Week 12, and Week 24 |
| Change in Absolute Regulatory B Cell Count | Percentage of regulatory B cells in the blood, assessed using flow cytometry. | Baseline, Week 12, and Week 24 |
| Change in the IgG4-RD Responder Index | The IgG4-RD Responder Index detects change in disease activity and identifies improvements/worsening in the same or different organ systems. It encompasses more than 25 organs/sites and records the following for each organ/site: (i) activity trend (through a 0-3 [normal/resolved - worsening] organ/site score); (ii) presence of symptoms due to active disease; (iii) need for urgent care; (iv) presence of damage; and (v) presence of symptoms due to damage. The final activity score at each visit is obtained by summing all organ/site scores (i) and by doubling items needing urgent care (iii). The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis. | Baseline, Week 12, and Week 24 |
| Proportion of Patients With no Disease Flares | Number and percentage of patients who did not have an IgG4-RD flare | Week 12 to Week 24 |
| Change in Total Salivary Grey Scale Ultrasound Score (TUS) | Each parotid and submandibular gland scored from 0 to 3 with a higher score indicating worse disease, total summed scores across all four glands will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Baseline, Week 12, and Week 24 |
| Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, highest score will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Baseline, Week 12, and Week 24 |
| Change in Glandular Inflammation Total Ultrasound Score (iTUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, total summed scores across all four glands will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Baseline, Week 12, and Week 24 |
| Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, highest score will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Baseline, Week 12, and Week 24 |
| Change in Physician Global Assessment of Disease | Symptoms rated on a 100 mm visual analog scale (VAS). Score range: 0 to 100, higher scores correspond to worse disease state. | Baseline, Week 12, and Week 24 |
| Change in Patient Global Assessment of Disease | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. | Baseline, Week 12, and Week 24 |
| Change in VAS for Ocular Symptoms - Dryness | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. | Baseline to Week 24 |
| Change in VAS for Dryness Symptoms | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to more dryness. Participants were asked to assess their dryness, taking into account all areas, including ocular and salivary symptoms. | Baseline, Week 12, Week 24 |
| Change in FACIT-F Fatigue Score | Total score range: 0-52, lower scores correspond with more fatigue. FACIT = Functional Assessment of Chronic Illness Therapy. | Baseline, Week 12, and Week 24 |
| Change in RAND Short Form-36 | The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. | Baseline, Week 12, and Week 24 |
| Change in C3 Lab | Complement component 3 (C3) level in blood | Baseline, Week 12, and Week 24 |
| Change in C4 Lab | Complement component 4 (C4) level in blood | Baseline, Week 12, and Week 24 |
| Change in Total IgG Lab | Baseline, Week 12, and Week 24 |
| Change in IgE Lab | Baseline, Week 12, and Week 24 |
| Change in IgG1 Lab | Baseline, Week 12, and Week 24 |
| Change in ESR Lab | Change in erythrocyte sedimentation rate (ESR) | Baseline, Week 12, and Week 24 |
| Change in CRP Lab | Change in serum C-reactive protein (CRP) level | Baseline, Week 12, and Week 24 |
| Incidence of Safety Parameters Including Adverse Events | Number of participants with treatment-emergent adverse events (TEAEs). | Baseline to Week 32 |
| Incidence of Safety Parameters Including Abnormal Laboratory Results | Number of participants with any grade 3 or 4 treatment-emergent laboratory abnormality | Baseline to Week 32 |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Volume of the Lacrimal Glands on PET-MRI | To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 24. | Posted | Mean | Standard Deviation | cm^3 | Baseline and Week 24 |
|
|
|
|
| Secondary | FDG Avidity (SUVmax) of the Submandibular Glands on PET | Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET at Weeks 12 and 24 compared to Baseline. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | kg/L | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | FDG Avidity (SUVmax) of the Lacrimal Glands on PET | Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET at Week 24 compared to Baseline. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | kg/L | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | cm^3 | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | grams | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Submandibular Glands on MRI | Change in parenchymal architecture scored 0 to 4 and sialography scored 0 to 4 where 0 is normal, healthy gland and 4 is worse outcome. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Parotid Glands on MRI | Change in parenchymal architecture scored 0 to 4 and sialography scored 0 to 4, where 0 is normal, healthy gland and 4 is worse outcome. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Lacrimal Glands on MRI | Change in parenchymal architecture scored 0 to 4, where 0 is normal, healthy gland and 4 is worse outcome. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in the Volume of the Parotid Glands on PET/MRI | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | cm^3 | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in the Volume of the Submandibular Glands on PET/MRI | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12. | Posted | Mean | Standard Deviation | cm^3 | Baseline and Week 12 |
|
|
|
|
| Secondary | Change in the Volume of the Lacrimal Glands on PET/MRI | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12. | Posted | Mean | Standard Deviation | cm^3 | Baseline, and Week 12 |
|
|
|
|
| Secondary | Change in the Volume of the Parotid Glands on PET/MRI | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | cm^3 | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Change in Serum IgG4 Level | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
|
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|
|
| Secondary | Change in Plasmablast Count | Change in percentage of CD19+ B cells in blood | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | percentage of cells | Baseline, Week 12, and Week 24 |
|
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|
|
| Secondary | Change in Absolute Regulatory B Cell Count | Percentage of regulatory B cells in the blood, assessed using flow cytometry. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | percentage of cells | Baseline, Week 12, and Week 24 |
|
|
|
| Secondary | Change in the IgG4-RD Responder Index | The IgG4-RD Responder Index detects change in disease activity and identifies improvements/worsening in the same or different organ systems. It encompasses more than 25 organs/sites and records the following for each organ/site: (i) activity trend (through a 0-3 [normal/resolved - worsening] organ/site score); (ii) presence of symptoms due to active disease; (iii) need for urgent care; (iv) presence of damage; and (v) presence of symptoms due to damage. The final activity score at each visit is obtained by summing all organ/site scores (i) and by doubling items needing urgent care (iii). The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, and Week 24 |
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|
| Secondary | Proportion of Patients With no Disease Flares | Number and percentage of patients who did not have an IgG4-RD flare | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Count of Participants | Participants | Week 12 to Week 24 |
|
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|
| Secondary | Change in Total Salivary Grey Scale Ultrasound Score (TUS) | Each parotid and submandibular gland scored from 0 to 3 with a higher score indicating worse disease, total summed scores across all four glands will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
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|
|
| Secondary | Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, highest score will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
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|
|
| Secondary | Change in Glandular Inflammation Total Ultrasound Score (iTUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, total summed scores across all four glands will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
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|
|
| Secondary | Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS) | Each parotid and submandibular gland (n=4) scored from 0 to 3 with a higher score indicating worse disease, highest score will be assessed for change (overall score range: 0 to 12, with a higher score indicating worse disease) | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
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| Secondary | Change in Physician Global Assessment of Disease | Symptoms rated on a 100 mm visual analog scale (VAS). Score range: 0 to 100, higher scores correspond to worse disease state. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
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| Secondary | Change in Patient Global Assessment of Disease | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
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| Secondary | Change in VAS for Ocular Symptoms - Dryness | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24 | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 24 |
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| Secondary | Change in VAS for Dryness Symptoms | Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to more dryness. Participants were asked to assess their dryness, taking into account all areas, including ocular and salivary symptoms. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, Week 24 |
|
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| Secondary | Change in FACIT-F Fatigue Score | Total score range: 0-52, lower scores correspond with more fatigue. FACIT = Functional Assessment of Chronic Illness Therapy. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
|
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| Secondary | Change in RAND Short Form-36 | The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, and Week 24 |
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| Secondary | Change in C3 Lab | Complement component 3 (C3) level in blood | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
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| Secondary | Change in C4 Lab | Complement component 4 (C4) level in blood | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
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| Secondary | Change in Total IgG Lab | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
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| Secondary | Change in IgE Lab | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | kU/L | Baseline, Week 12, and Week 24 |
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| Secondary | Change in IgG1 Lab | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24 | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
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| Secondary | Change in ESR Lab | Change in erythrocyte sedimentation rate (ESR) | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mm/hr | Baseline, Week 12, and Week 24 |
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| Secondary | Change in CRP Lab | Change in serum C-reactive protein (CRP) level | Per-Protocol Analysis Set: all subjects who were enrolled in the study, received at least 1 dose of study drug, and had a follow-up imaging study at Week 12 and/or Week 24. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12, and Week 24 |
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| Secondary | Incidence of Safety Parameters Including Adverse Events | Number of participants with treatment-emergent adverse events (TEAEs). | Posted | Count of Participants | Participants | Baseline to Week 32 |
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| Secondary | Incidence of Safety Parameters Including Abnormal Laboratory Results | Number of participants with any grade 3 or 4 treatment-emergent laboratory abnormality | Posted | Count of Participants | Participants | Baseline to Week 32 |
|
|
|
| 10 |
| 1 |
| 10 |
| 10 |
| 10 |
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Bullous pemphigoid | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Otitis externa | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Sinus infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Oral lesion | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Soft tissue mass | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypernatremia | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
|
| Change from Baseline at Week 24 |
|
|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.05 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.01 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.05 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.05 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 (architecture) |
|
|
| Week 24 (architecture) |
|
|
| Change from Baseline at Week 24 (architecture) |
|
|
| Baseline (saliography) |
|
|
| Week 12 (saliography) |
|
|
| Change from Baseline at Week 12 (sialography) |
|
|
| Week 24 (sialography) |
|
|
| Change from Baseline at Week 24 (sialography) |
|
|
| Wilcoxon signed-rank test |
| 0.3 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 (architecture) |
|
|
| Week 24 (architecture) |
|
|
| Change from Baseline at Week 24 (architecture) |
|
|
| Baseline (sialography) |
|
|
| Week 12 (sialography) |
|
|
| Change from Baseline at Week 12 (sialography) |
|
|
| Week 24 (sialography) |
|
|
| Change from Baseline at Week 24 (sialography) |
|
|
| Wilcoxon signed-rank test |
| 0.03 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.03 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| < 0.001 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
|
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| < 0.001 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.02 |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.02 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.02 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.06 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.04 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.07 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.09 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.02 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.05 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.1 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.1 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.5 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.5 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.8 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.9 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.1 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.2 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.2 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 0.1 |
The a priori threshold for statistical significance is <0.05. |
| Other |
|
| Change from Baseline at Week 12 |
|
|
| Week 24 |
|
|
| Change from Baseline at Week 24 |
|
|
| Wilcoxon signed-rank test |
| 1 |
The a priori threshold for statistical significance is <0.05. |
| Other |
| TEAE Related to Study Drug with Grade 3 or Higher |
|
| TE Serious AE |
|
| TE Serious AE Related to Study Drug |
|
| TEAE Leading to Premature Discontinuation of Study Drug |
|
| TEAE Leading to Premature Discontinuation of Study |
|