Trial Outcomes & Findings for Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD) (NCT NCT02725476)
NCT ID: NCT02725476
Last Updated: 2018-12-07
Results Overview
Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline Day 1 to Day 169
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
XmAb5871 5 mg/kg
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
|
Overall Study
COMPLETED
|
12
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
XmAb5871 5 mg/kg
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
Baseline characteristics by cohort
| Measure |
XmAb5871 5 mg/kg
n=15 Participants
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
n=5 Participants
90 mg or 180 mg fixed dose group
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.57 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 14.11 • n=107 Participants
|
57.9 years
STANDARD_DEVIATION 11.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Serum IgG4 level at Baseline
|
440.33 mg/dL
STANDARD_DEVIATION 622.990 • n=99 Participants
|
858.60 mg/dL
STANDARD_DEVIATION 351.608 • n=107 Participants
|
544.90 mg/dL
STANDARD_DEVIATION 588.674 • n=206 Participants
|
|
Involved Areas at Baseline
Bile Ducts
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Constitutional Symptoms
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Heart / Pericardium
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Kidney
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Lacrimal Glands
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Lungs
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Lymph Nodes
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Nasal Cavity Lesion
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Orbital Lesion
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Other
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Other ENT Lesions, e.g. tonsillitis, pharyngitis
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Other Salivary Glands
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Pancreas
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Parotid Glands
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Retroperitoneal Fibrosis
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Sinusitis
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Skin
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Involved Areas at Baseline
Submandibular Glands
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Baseline IgG4-RD Responder Index Total Activity Score
|
11.5 Total Activity Score
STANDARD_DEVIATION 6.65 • n=99 Participants
|
12.8 Total Activity Score
STANDARD_DEVIATION 6.42 • n=107 Participants
|
11.8 Total Activity Score
STANDARD_DEVIATION 6.45 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline Day 1 to Day 169Population: Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871.
Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. 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 |
XmAb5871 5 mg/kg
n=15 Participants
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
n=5 Participants
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Proportion of Patients With an Improvement in IgG4-RD Activity
Responder at Day 169 visit
|
12 Participants
|
4 Participants
|
|
Proportion of Patients With an Improvement in IgG4-RD Activity
Non-Responder at Day 169 visit
|
2 Participants
|
0 Participants
|
|
Proportion of Patients With an Improvement in IgG4-RD Activity
Not Assessed at Day 169 visit
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline Day 1 to Day 197Population: Safety Population: All patients who receive at least a partial dose of XmAb5871.
The number of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 will be tabulated according to MedDRA system-organ class and preferred term, intensity and causality.
Outcome measures
| Measure |
XmAb5871 5 mg/kg
n=15 Participants
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
n=5 Participants
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3
|
13 Participants
|
5 Participants
|
Adverse Events
XmAb5871 5 mg/kg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
XmAb5871 Fixed Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XmAb5871 5 mg/kg
n=15 participants at risk
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
n=5 participants at risk
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
0.00%
0/5 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/15 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
20.0%
1/5 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/15 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
20.0%
1/5 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
Other adverse events
| Measure |
XmAb5871 5 mg/kg
n=15 participants at risk
5 mg/kg weight-based dosing group
|
XmAb5871 Fixed Dose
n=5 participants at risk
90 mg or 180 mg fixed dose group
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 5 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
20.0%
1/5 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
40.0%
2/5 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
40.0%
2/5 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
0.00%
0/5 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
General disorders
Chills
|
13.3%
2/15 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
0.00%
0/5 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
0.00%
0/5 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
20.0%
1/5 • Number of events 1 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
40.0%
2/5 • Number of events 2 • Day 1 (First Dose) through Day 197
Note that due to the small total of 20 participants, the frequency threshold for reporting other adverse events applies to the total participants rather than the two defined dosing groups. Specifically, the threshold is adverse events occurring in 2 or more of 20 total participants (i.e. \> 5% of 20).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place