Trial Outcomes & Findings for An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) (NCT NCT04620811)
NCT ID: NCT04620811
Last Updated: 2024-04-22
Results Overview
Adverse events assessed using the CTCAE version 5.0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
159 participants
Primary outcome timeframe
Through study completion, up to 21 months
Results posted on
2024-04-22
Participant Flow
The participants who were enrolled in and completed the studies AK002-016 (NCT04322604) or AK002-012 had the option to participate in this open-label extension study.
Participant milestones
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
84
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
33
|
44
|
Reasons for withdrawal
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
15
|
|
Overall Study
Adverse Event
|
6
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Elevation of ALT or AST
|
1
|
0
|
|
Overall Study
Other
|
3
|
5
|
Baseline Characteristics
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Baseline characteristics by cohort
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=75 Participants
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=84 Participants
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=99 Participants
|
42 years
n=107 Participants
|
42 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
136 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
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
75 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 21 monthsAdverse events assessed using the CTCAE version 5.0.
Outcome measures
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=75 Participants
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=84 Participants
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
No. of Subjects with >=1 Treatment-Related Serious Adverse Events
|
1 Participants
|
1 Participants
|
|
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
No. of Subjects with >=1 Adverse Events
|
66 Participants
|
75 Participants
|
|
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
No. of Subjects with >=1 Treatment-Related Adverse Events
|
33 Participants
|
29 Participants
|
|
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
No. of Subjects with >=1 Serious Adverse Events
|
6 Participants
|
14 Participants
|
|
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation
|
6 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)Population: Safety Population
A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.
Outcome measures
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=54 Participants
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=52 Participants
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Proportion of Tissue Eosinophil Responders
|
52 Participants
|
48 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Main Study Baseline to Extension Weeks 71-72Population: Number of participants with available data within Safety Population
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Outcome measures
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=46 Participants
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=41 Participants
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline
|
-14.4 score on a scale
Standard Deviation 11.0
|
-17.0 score on a scale
Standard Deviation 12.1
|
Adverse Events
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
Serious events: 14 serious events
Other events: 57 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=75 participants at risk
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=84 participants at risk
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Death
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Pyrexia
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Appendicitis
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.4%
2/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Cellulitis
|
2.7%
2/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Pelvic abscess
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Syncope
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
Other adverse events
| Measure |
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=75 participants at risk
Subjects in this arm received the placebo in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
n=84 participants at risk
Subjects in this arm received the active drug in the main study and were treated with up to 18 monthly doses (3mg/kg) of lirentelimab (AK002).
lirentelimab: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
7.1%
6/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
7/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
10.7%
9/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Diarrhoea
|
14.7%
11/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
9.5%
8/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
5.3%
4/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
3.6%
3/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Nausea
|
14.7%
11/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
6.0%
5/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
11.9%
10/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Immune system disorders
Hypersensitivity
|
5.3%
4/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.4%
2/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Corona virus infection
|
20.0%
15/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
25.0%
21/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
6/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
4.8%
4/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Sinusitis
|
5.3%
4/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
4.8%
4/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Urinary tract infection
|
10.7%
8/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
6.0%
5/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
36.0%
27/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
22.6%
19/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Investigations
Coronavirus test positive
|
1.3%
1/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
7.1%
6/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
4/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
9.5%
8/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Headache
|
8.0%
6/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.3%
7/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Psychiatric disorders
Depression
|
0.00%
0/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
6.0%
5/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
4/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
1.2%
1/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
3/75 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
6.0%
5/84 • Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Trial Agreement contains a limit on publication of results following completion of the trial. PIs are not allowed to publish results until a joint publication for the multicenter study or a set period of time. After that time, PIs may only publish results from their portion of the study.
- Publication restrictions are in place
Restriction type: OTHER