Trial Outcomes & Findings for An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (NCT NCT03664960)
NCT ID: NCT03664960
Last Updated: 2024-02-28
Results Overview
Adverse events assessed using the CTCAE version 4.03
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Through study completion, up to 28 months
Results posted on
2024-02-28
Participant Flow
The participants who were enrolled in and completed the study NCT03496571 had the option to participate in this open-label extension study.
Participant milestones
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
37
|
|
Overall Study
COMPLETED
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
9
|
22
|
Reasons for withdrawal
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
14
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Baseline characteristics by cohort
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
n=21 Participants
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 Participants
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=99 Participants
|
43 years
n=107 Participants
|
40 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
53 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
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
54 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
|
21 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 28 monthsAdverse events assessed using the CTCAE version 4.03
Outcome measures
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
n=21 Participants
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 Participants
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Subjects with ≥1 adverse events
|
21 Participants
|
35 Participants
|
|
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Subjects with ≥1 treatment-related adverse events
|
15 Participants
|
22 Participants
|
|
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Subjects with an adverse event leading to study discontinuation
|
0 Participants
|
3 Participants
|
|
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Subjects with ≥1 serious adverse events
|
2 Participants
|
9 Participants
|
|
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Subjects with ≥1 treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.
Outcome measures
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
n=21 Participants
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 Participants
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
|
-66.3 Percentage of change
Standard Deviation 27.7
|
-60.6 Percentage of change
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: AK002-003 Baseline to Day 547Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline
Outcome measures
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
n=21 Participants
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 Participants
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline
|
-93.5 Percentage of change
Standard Deviation 18.9
|
-99.7 Percentage of change
Standard Deviation 0.7
|
Adverse Events
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
n=21 participants at risk
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 participants at risk
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Abdominal hiernia
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 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 1 to 3.0 mg/kg of AK002
n=21 participants at risk
Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
n=37 participants at risk
Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
10.8%
4/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Blood and lymphatic system disorders
Neutrophilia
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
10.8%
4/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
0.00%
0/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
13.5%
5/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Chest pain
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Fatigue
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Influenza like illness
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Injection site pain
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
General disorders
Pyrexia
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Influenza
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
10.8%
4/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Nasopharyngitis
|
23.8%
5/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
13.5%
5/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
13.5%
5/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
10.8%
4/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
42.9%
9/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
29.7%
11/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Investigations
Blood creatine phosphokinase increased
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
13.5%
5/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
18.9%
7/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Psychiatric disorders
Anxiety
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.8%
1/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
5.4%
2/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
2.7%
1/37 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • Through study completion, up to 28 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
|
8.1%
3/37 • Through study completion, up to 28 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