Trial Outcomes & Findings for Zanubrutinib in Patients With IgG4-Related Disease (NCT NCT04602598)
NCT ID: NCT04602598
Last Updated: 2026-04-01
Results Overview
To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.
COMPLETED
PHASE2
10 participants
Baseline and Week 24
2026-04-01
Participant Flow
Participant milestones
| Measure |
Zanubrutinib
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Completed Week 12 Imaging
|
8
|
|
Overall Study
Completed Week 24 Imaging
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zanubrutinib in Patients With IgG4-Related Disease
Baseline characteristics by cohort
| Measure |
Zanubrutinib
n=10 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Age, Customized
<50 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
>=50 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
To demonstrate that zanubrutinib treatment reduces the volume of the submandibular glands on PET-MRI at week 24 compared to Baseline.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Volume of the Submandibular Glands on PET-MRI
Week 24
|
9.34 cm^3
Standard Deviation 4.80
|
|
Volume of the Submandibular Glands on PET-MRI
Change from Baseline at Week 24
|
-3.37 cm^3
Standard Deviation 2.40
|
|
Volume of the Submandibular Glands on PET-MRI
Baseline
|
12.7 cm^3
Standard Deviation 5.78
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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.
To demonstrate that zanubrutinib treatment reduces the volume of the lacrimal glands on PET-MRI at Week 24 compared to Baseline.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Volume of the Lacrimal Glands on PET-MRI
Baseline
|
2.59 cm^3
Standard Deviation 2.18
|
|
Volume of the Lacrimal Glands on PET-MRI
Week 24
|
1.17 cm^3
Standard Deviation 0.520
|
|
Volume of the Lacrimal Glands on PET-MRI
Change from Baseline at Week 24
|
-1.42 cm^3
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Effect of zanubrutinib on change in FDG avidity (SUVmax) of the submandibular glands on PET at Weeks 12 and 24 compared to Baseline.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
FDG Avidity (SUVmax) of the Submandibular Glands on PET
Week 24
|
3.27 kg/L
Standard Deviation 1.05
|
|
FDG Avidity (SUVmax) of the Submandibular Glands on PET
Change from Baseline at Week 24
|
-2.06 kg/L
Standard Deviation 3.41
|
|
FDG Avidity (SUVmax) of the Submandibular Glands on PET
Change from Baseline at Week 12
|
-1.91 kg/L
Standard Deviation 3.14
|
|
FDG Avidity (SUVmax) of the Submandibular Glands on PET
Baseline
|
5.33 kg/L
Standard Deviation 3.77
|
|
FDG Avidity (SUVmax) of the Submandibular Glands on PET
Week 12
|
3.42 kg/L
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Effect of zanubrutinib on change in FDG avidity (SUVmax) of the lacrimal glands on PET at Week 24 compared to Baseline.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
FDG Avidity (SUVmax) of the Lacrimal Glands on PET
Baseline
|
5.52 kg/L
Standard Deviation 2.48
|
|
FDG Avidity (SUVmax) of the Lacrimal Glands on PET
Week 12
|
3.37 kg/L
Standard Deviation 1.18
|
|
FDG Avidity (SUVmax) of the Lacrimal Glands on PET
Change from Baseline at Week 12
|
-2.15 kg/L
Standard Deviation 2.45
|
|
FDG Avidity (SUVmax) of the Lacrimal Glands on PET
Week 24
|
3.23 kg/L
Standard Deviation 1.27
|
|
FDG Avidity (SUVmax) of the Lacrimal Glands on PET
Change from Baseline at Week 24
|
-2.29 kg/L
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET
Baseline
|
24.3 cm^3
Standard Deviation 20.6
|
|
Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET
Week 12
|
5.19 cm^3
Standard Deviation 2.10
|
|
Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET
Change from Baseline at Week 12
|
-19.2 cm^3
Standard Deviation 20.5
|
|
Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET
Week 24
|
3.64 cm^3
Standard Deviation 2.56
|
|
Change in Total Metabolic Lesion Volume (tMLV) of Lacrimal Glands, Submandibular Glands, Parotid Glands, and Lymph Notes on PET
Change from Baseline at Week 24
|
-20.7 cm^3
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET
Baseline
|
103 grams
Standard Deviation 92.1
|
|
Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET
Week 12
|
16.1 grams
Standard Deviation 7.54
|
|
Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET
Change from Baseline at Week 12
|
-86.7 grams
Standard Deviation 91.3
|
|
Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET
Week 24
|
11.2 grams
Standard Deviation 9.91
|
|
Change in Total Lesion Glycolysis (TLG) of Submandibular and/or Lacrimal Glands on PET
Change from Baseline at Week 24
|
-91.6 grams
Standard Deviation 98.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Submandibular Glands on MRI
Change from Baseline at Week 12 (architecture)
|
0.125 score on a scale
Standard Deviation 0.342
|
|
Change in Submandibular Glands on MRI
Week 24 (architecture)
|
1.38 score on a scale
Standard Deviation 0.806
|
|
Change in Submandibular Glands on MRI
Change from Baseline at Week 24 (architecture)
|
0.250 score on a scale
Standard Deviation 0.683
|
|
Change in Submandibular Glands on MRI
Baseline (saliography)
|
1.00 score on a scale
Standard Deviation 0
|
|
Change in Submandibular Glands on MRI
Week 12 (saliography)
|
1.00 score on a scale
Standard Deviation 0
|
|
Change in Submandibular Glands on MRI
Change from Baseline at Week 12 (sialography)
|
0 score on a scale
Standard Deviation 0
|
|
Change in Submandibular Glands on MRI
Week 24 (sialography)
|
1.00 score on a scale
Standard Deviation 0
|
|
Change in Submandibular Glands on MRI
Baseline (architecture)
|
1.13 score on a scale
Standard Deviation 0.500
|
|
Change in Submandibular Glands on MRI
Week 12 (architecture)
|
1.25 score on a scale
Standard Deviation 0.577
|
|
Change in Submandibular Glands on MRI
Change from Baseline at Week 24 (sialography)
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Parotid Glands on MRI
Baseline (architecture)
|
2.13 score on a scale
Standard Deviation 0.957
|
|
Change in Parotid Glands on MRI
Week 12 (architecture)
|
1.63 score on a scale
Standard Deviation 0.719
|
|
Change in Parotid Glands on MRI
Change from Baseline at Week 12 (architecture)
|
-0.500 score on a scale
Standard Deviation 0.730
|
|
Change in Parotid Glands on MRI
Week 24 (architecture)
|
1.63 score on a scale
Standard Deviation 0.719
|
|
Change in Parotid Glands on MRI
Change from Baseline at Week 24 (architecture)
|
-0.500 score on a scale
Standard Deviation 0.730
|
|
Change in Parotid Glands on MRI
Baseline (sialography)
|
1.13 score on a scale
Standard Deviation 0.342
|
|
Change in Parotid Glands on MRI
Week 12 (sialography)
|
1.13 score on a scale
Standard Deviation 0.342
|
|
Change in Parotid Glands on MRI
Change from Baseline at Week 12 (sialography)
|
0 score on a scale
Standard Deviation 0
|
|
Change in Parotid Glands on MRI
Week 24 (sialography)
|
1.13 score on a scale
Standard Deviation 0.342
|
|
Change in Parotid Glands on MRI
Change from Baseline at Week 24 (sialography)
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Change in parenchymal architecture scored 0 to 4, where 0 is normal, healthy gland and 4 is worse outcome.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Lacrimal Glands on MRI
Baseline
|
2.13 score on a scale
Standard Deviation 1.09
|
|
Change in Lacrimal Glands on MRI
Week 12
|
2.50 score on a scale
Standard Deviation 0.894
|
|
Change in Lacrimal Glands on MRI
Change from Baseline at Week 12
|
0.375 score on a scale
Standard Deviation 0.500
|
|
Change in Lacrimal Glands on MRI
Week 24
|
2.69 score on a scale
Standard Deviation 0.946
|
|
Change in Lacrimal Glands on MRI
Change from Baseline at Week 24
|
0.563 score on a scale
Standard Deviation 0.814
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in the Volume of the Parotid Glands on PET/MRI
Baseline
|
44.6 cm^3
Standard Deviation 14.6
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Week 12
|
39.6 cm^3
Standard Deviation 11.6
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Change from Baseline at Week 12
|
-5.07 cm^3
Standard Deviation 5.04
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Week 24
|
38 cm^3
Standard Deviation 11.7
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Change from Baseline at Week 24
|
-6.66 cm^3
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in the Volume of the Submandibular Glands on PET/MRI
Baseline
|
12.7 cm^3
Standard Deviation 5.78
|
|
Change in the Volume of the Submandibular Glands on PET/MRI
Week 12
|
10.0 cm^3
Standard Deviation 4.97
|
|
Change in the Volume of the Submandibular Glands on PET/MRI
Change from Baseline at Week 12
|
-2.69 cm^3
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Baseline, and Week 12Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in the Volume of the Lacrimal Glands on PET/MRI
Baseline
|
2.59 cm^3
Standard Deviation 2.18
|
|
Change in the Volume of the Lacrimal Glands on PET/MRI
Week 12
|
1.50 cm^3
Standard Deviation 0.89
|
|
Change in the Volume of the Lacrimal Glands on PET/MRI
Change from Baseline at Week 12
|
-1.09 cm^3
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in the Volume of the Parotid Glands on PET/MRI
Baseline
|
44.6 cm^3
Standard Deviation 14.6
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Change from Baseline at Week 12
|
-5.07 cm^3
Standard Deviation 5.04
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Week 24
|
38 cm^3
Standard Deviation 11.7
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Change from Baseline at Week 24
|
-6.66 cm^3
Standard Deviation 5.04
|
|
Change in the Volume of the Parotid Glands on PET/MRI
Week 12
|
39.6 cm^3
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Serum IgG4 Level
Baseline
|
643 mg/dL
Standard Deviation 567
|
|
Change in Serum IgG4 Level
Week 12
|
342 mg/dL
Standard Deviation 305
|
|
Change in Serum IgG4 Level
Change from Baseline at Week 12
|
-301 mg/dL
Standard Deviation 278
|
|
Change in Serum IgG4 Level
Week 24
|
226 mg/dL
Standard Deviation 179
|
|
Change in Serum IgG4 Level
Change from Baseline at Week 24
|
-413 mg/dL
Standard Deviation 443
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Change in percentage of CD19+ B cells in blood
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Plasmablast Count
Baseline
|
17.8 percentage of cells
Standard Deviation 25.2
|
|
Change in Plasmablast Count
Week 12
|
0.175 percentage of cells
Standard Deviation 0.205
|
|
Change in Plasmablast Count
Change from Baseline at Week 12
|
-17.6 percentage of cells
Standard Deviation 25.1
|
|
Change in Plasmablast Count
Week 24
|
0.213 percentage of cells
Standard Deviation 0.259
|
|
Change in Plasmablast Count
Change from Baseline at Week 24
|
-19.6 percentage of cells
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Percentage of regulatory B cells in the blood, assessed using flow cytometry.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Absolute Regulatory B Cell Count
Baseline
|
3.03 percentage of cells
Standard Deviation 2.53
|
|
Change in Absolute Regulatory B Cell Count
Week 12
|
0.538 percentage of cells
Standard Deviation 1.03
|
|
Change in Absolute Regulatory B Cell Count
Change from Baseline at Week 12
|
-2.49 percentage of cells
Standard Deviation 2.40
|
|
Change in Absolute Regulatory B Cell Count
Week 24
|
0.450 percentage of cells
Standard Deviation 0.404
|
|
Change in Absolute Regulatory B Cell Count
Change from Baseline at Week 24
|
-2.58 percentage of cells
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in the IgG4-RD Responder Index
Baseline
|
6.63 units on a scale
Standard Deviation 0.916
|
|
Change in the IgG4-RD Responder Index
Week 12
|
2.38 units on a scale
Standard Deviation 2.07
|
|
Change in the IgG4-RD Responder Index
Change from Baseline at Week 12
|
-4.25 units on a scale
Standard Deviation 2.49
|
|
Change in the IgG4-RD Responder Index
Week 24
|
2.00 units on a scale
Standard Deviation 2.20
|
|
Change in the IgG4-RD Responder Index
Change from Baseline at Week 24
|
-4.63 units on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Week 12 to Week 24Population: 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.
Number and percentage of patients who did not have an IgG4-RD flare
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Proportion of Patients With no Disease Flares
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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)
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Total Salivary Grey Scale Ultrasound Score (TUS)
Baseline
|
5.3 score on a scale
Standard Deviation 3.8
|
|
Change in Total Salivary Grey Scale Ultrasound Score (TUS)
Week 12
|
4.4 score on a scale
Standard Deviation 3.0
|
|
Change in Total Salivary Grey Scale Ultrasound Score (TUS)
Change from Baseline at Week 12
|
-0.88 score on a scale
Standard Deviation 1.25
|
|
Change in Total Salivary Grey Scale Ultrasound Score (TUS)
Week 24
|
3.5 score on a scale
Standard Deviation 1.9
|
|
Change in Total Salivary Grey Scale Ultrasound Score (TUS)
Change from Baseline at Week 24
|
-1.75 score on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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)
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)
Baseline
|
2.3 score on a scale
Standard Deviation 0.71
|
|
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)
Week 12
|
1.9 score on a scale
Standard Deviation 0.84
|
|
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)
Change from Baseline at Week 12
|
-0.38 score on a scale
Standard Deviation 0.52
|
|
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)
Week 24
|
1.6 score on a scale
Standard Deviation 0.74
|
|
Change in Highest Score Among the Salivary Glands for the Grey Scale Ultrasound Score (HSUS)
Change from Baseline at Week 24
|
-0.63 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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)
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Glandular Inflammation Total Ultrasound Score (iTUS)
Baseline
|
7.4 score on a scale
Standard Deviation 2.7
|
|
Change in Glandular Inflammation Total Ultrasound Score (iTUS)
Week 12
|
6.4 score on a scale
Standard Deviation 1.6
|
|
Change in Glandular Inflammation Total Ultrasound Score (iTUS)
Change from Baseline at Week 12
|
-1.00 score on a scale
Standard Deviation 1.77
|
|
Change in Glandular Inflammation Total Ultrasound Score (iTUS)
Week 24
|
5.3 score on a scale
Standard Deviation 1.5
|
|
Change in Glandular Inflammation Total Ultrasound Score (iTUS)
Change from Baseline at Week 24
|
-2.13 score on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
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)
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)
Baseline
|
2.4 score on a scale
Standard Deviation 0.92
|
|
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)
Week 12
|
2.1 score on a scale
Standard Deviation 0.84
|
|
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)
Change from Baseline at Week 12
|
-0.25 score on a scale
Standard Deviation 0.46
|
|
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)
Week 24
|
1.8 score on a scale
Standard Deviation 0.71
|
|
Change in Highest Score Among the Salivary Glands for the Glandular Inflammation Ultrasound Score (iHSUS)
Change from Baseline at Week 24
|
-0.63 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Symptoms rated on a 100 mm visual analog scale (VAS). Score range: 0 to 100, higher scores correspond to worse disease state.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Physician Global Assessment of Disease
Change from Baseline at Week 24
|
-51.0 score on a scale
Standard Deviation 28.3
|
|
Change in Physician Global Assessment of Disease
Baseline
|
68.4 score on a scale
Standard Deviation 12.7
|
|
Change in Physician Global Assessment of Disease
Week 12
|
21.4 score on a scale
Standard Deviation 29.4
|
|
Change in Physician Global Assessment of Disease
Change from Baseline at Week 12
|
-47.0 score on a scale
Standard Deviation 27.8
|
|
Change in Physician Global Assessment of Disease
Week 24
|
17.4 score on a scale
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Patient Global Assessment of Disease
Baseline
|
52.4 score on a scale
Standard Deviation 19.6
|
|
Change in Patient Global Assessment of Disease
Week 12
|
38.4 score on a scale
Standard Deviation 30.4
|
|
Change in Patient Global Assessment of Disease
Change from Baseline at Week 12
|
-14.0 score on a scale
Standard Deviation 27.1
|
|
Change in Patient Global Assessment of Disease
Week 24
|
31.0 score on a scale
Standard Deviation 25.8
|
|
Change in Patient Global Assessment of Disease
Change from Baseline at Week 24
|
-21.4 score on a scale
Standard Deviation 26.6
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: 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
Symptoms rated on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in VAS for Ocular Symptoms - Dryness
Baseline
|
47.6 score on a scale
Standard Deviation 25.3
|
|
Change in VAS for Ocular Symptoms - Dryness
Week 12
|
31.9 score on a scale
Standard Deviation 20.9
|
|
Change in VAS for Ocular Symptoms - Dryness
Change from Baseline at Week 12
|
-15.8 score on a scale
Standard Deviation 28.9
|
|
Change in VAS for Ocular Symptoms - Dryness
Week 24
|
21.5 score on a scale
Standard Deviation 15.1
|
|
Change in VAS for Ocular Symptoms - Dryness
Change from Baseline at Week 24
|
-26.1 score on a scale
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: 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.
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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in VAS for Dryness Symptoms
Baseline
|
47.6 score on a scale
Standard Deviation 25.3
|
|
Change in VAS for Dryness Symptoms
Week 12
|
31.9 score on a scale
Standard Deviation 20.9
|
|
Change in VAS for Dryness Symptoms
Change from Baseline at Week 12
|
-15.8 score on a scale
Standard Deviation 28.9
|
|
Change in VAS for Dryness Symptoms
Week 24
|
21.5 score on a scale
Standard Deviation 15.1
|
|
Change in VAS for Dryness Symptoms
Change from Baseline at Week 24
|
-26.1 score on a scale
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Total score range: 0-52, lower scores correspond with more fatigue. FACIT = Functional Assessment of Chronic Illness Therapy.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in FACIT-F Fatigue Score
Baseline
|
38.9 score on a scale
Standard Deviation 14.0
|
|
Change in FACIT-F Fatigue Score
Week 12
|
41.6 score on a scale
Standard Deviation 9.12
|
|
Change in FACIT-F Fatigue Score
Change from Baseline at Week 12
|
2.75 score on a scale
Standard Deviation 10.4
|
|
Change in FACIT-F Fatigue Score
Week 24
|
43.3 score on a scale
Standard Deviation 5.80
|
|
Change in FACIT-F Fatigue Score
Change from Baseline at Week 24
|
4.38 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in RAND Short Form-36
Baseline
|
85.6 score on a scale
Standard Deviation 15.5
|
|
Change in RAND Short Form-36
Week 12
|
78.8 score on a scale
Standard Deviation 30.3
|
|
Change in RAND Short Form-36
Change from Baseline at Week 12
|
-6.88 score on a scale
Standard Deviation 23.0
|
|
Change in RAND Short Form-36
Week 24
|
78.1 score on a scale
Standard Deviation 29.1
|
|
Change in RAND Short Form-36
Change from Baseline at Week 24
|
-7.50 score on a scale
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Complement component 3 (C3) level in blood
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in C3 Lab
Baseline
|
116 mg/dL
Standard Deviation 29.0
|
|
Change in C3 Lab
Week 12
|
114 mg/dL
Standard Deviation 16.7
|
|
Change in C3 Lab
Change from Baseline at Week 12
|
1.86 mg/dL
Standard Deviation 22.3
|
|
Change in C3 Lab
Week 24
|
121 mg/dL
Standard Deviation 23.7
|
|
Change in C3 Lab
Change from Baseline at Week 24
|
6.43 mg/dL
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Complement component 4 (C4) level in blood
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in C4 Lab
Baseline
|
28.6 mg/dL
Standard Deviation 14.1
|
|
Change in C4 Lab
Week 12
|
31.5 mg/dL
Standard Deviation 8.93
|
|
Change in C4 Lab
Change from Baseline at Week 12
|
2.88 mg/dL
Standard Deviation 9.51
|
|
Change in C4 Lab
Week 24
|
31.0 mg/dL
Standard Deviation 8.00
|
|
Change in C4 Lab
Change from Baseline at Week 24
|
2.00 mg/dL
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in Total IgG Lab
Baseline
|
1610 mg/dL
Standard Deviation 578
|
|
Change in Total IgG Lab
Week 12
|
1240 mg/dL
Standard Deviation 286
|
|
Change in Total IgG Lab
Change from Baseline at Week 12
|
-368 mg/dL
Standard Deviation 345
|
|
Change in Total IgG Lab
Week 24
|
1200 mg/dL
Standard Deviation 316
|
|
Change in Total IgG Lab
Change from Baseline at Week 24
|
-395 mg/dL
Standard Deviation 570
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in IgE Lab
Week 12
|
1230 kU/L
Standard Deviation 1070
|
|
Change in IgE Lab
Change from Baseline at Week 12
|
672 kU/L
Standard Deviation 965
|
|
Change in IgE Lab
Week 24
|
1280 kU/L
Standard Deviation 1010
|
|
Change in IgE Lab
Change from Baseline at Week 24
|
544 kU/L
Standard Deviation 817
|
|
Change in IgE Lab
Baseline
|
562 kU/L
Standard Deviation 396
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in IgG1 Lab
Baseline
|
572 mg/dL
Standard Deviation 106
|
|
Change in IgG1 Lab
Week 12
|
491 mg/dL
Standard Deviation 67.0
|
|
Change in IgG1 Lab
Change from Baseline at Week 12
|
-80.8 mg/dL
Standard Deviation 65.2
|
|
Change in IgG1 Lab
Week 24
|
505 mg/dL
Standard Deviation 125
|
|
Change in IgG1 Lab
Change from Baseline at Week 24
|
-71.2 mg/dL
Standard Deviation 109
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Change in erythrocyte sedimentation rate (ESR)
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in ESR Lab
Baseline
|
20.4 mm/hr
Standard Deviation 19.7
|
|
Change in ESR Lab
Week 12
|
9.00 mm/hr
Standard Deviation 5.26
|
|
Change in ESR Lab
Change from Baseline at Week 12
|
-11.4 mm/hr
Standard Deviation 15.9
|
|
Change in ESR Lab
Week 24
|
8.75 mm/hr
Standard Deviation 3.85
|
|
Change in ESR Lab
Change from Baseline at Week 24
|
-12.9 mm/hr
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: 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.
Change in serum C-reactive protein (CRP) level
Outcome measures
| Measure |
Zanubrutinib
n=8 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Change in CRP Lab
Baseline
|
0.313 mg/dL
Standard Deviation 0.0354
|
|
Change in CRP Lab
Week 12
|
0.313 mg/dL
Standard Deviation 0.0354
|
|
Change in CRP Lab
Change from Baseline at Week 12
|
0 mg/dL
Standard Deviation 0.0535
|
|
Change in CRP Lab
Week 24
|
0.300 mg/dL
Standard Deviation 0
|
|
Change in CRP Lab
Change from Baseline at Week 24
|
-0.0143 mg/dL
Standard Deviation 0.0378
|
SECONDARY outcome
Timeframe: Baseline to Week 32Number of participants with treatment-emergent adverse events (TEAEs).
Outcome measures
| Measure |
Zanubrutinib
n=10 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Incidence of Safety Parameters Including Adverse Events
TEAE
|
10 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TEAE with Grade 3 or Higher
|
2 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TEAE Related to Study Drug
|
8 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TEAE Related to Study Drug with Grade 3 or Higher
|
1 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TE Serious AE
|
1 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TE Serious AE Related to Study Drug
|
0 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TEAE Leading to Premature Discontinuation of Study Drug
|
2 Participants
|
|
Incidence of Safety Parameters Including Adverse Events
TEAE Leading to Premature Discontinuation of Study
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 32Number of participants with any grade 3 or 4 treatment-emergent laboratory abnormality
Outcome measures
| Measure |
Zanubrutinib
n=10 Participants
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Incidence of Safety Parameters Including Abnormal Laboratory Results
|
2 Participants
|
Adverse Events
Zanubrutinib
Serious adverse events
| Measure |
Zanubrutinib
n=10 participants at risk
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
Other adverse events
| Measure |
Zanubrutinib
n=10 participants at risk
Zanubrutinib orally at a dose of 80mg BID for 24 weeks
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
4/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
20.0%
2/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Skin and subcutaneous tissue disorders
Bullous pemphigoid
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Ear and labyrinth disorders
Otitis externa
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Infections and infestations
Sinus infection
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Gastrointestinal disorders
Oral lesion
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
General disorders
Hypernatremia
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
|
Nervous system disorders
Parkinsonism
|
10.0%
1/10 • Up to 32 weeks (24 weeks treatment plus 8 weeks follow-up)
|
Additional Information
Matthew Baker
Stanford University, School of Medicine, Division of Immunology & Rheumatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place