Trial Outcomes & Findings for A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis (NCT NCT04322708)
NCT ID: NCT04322708
Last Updated: 2024-01-02
Results Overview
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
277 participants
Primary outcome timeframe
At Week 24
Results posted on
2024-01-02
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
1 mg/kg of Lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
93
|
91
|
|
Overall Study
COMPLETED
|
89
|
89
|
85
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
AK002 1 mg/kg
n=93 Participants
Patients randomized to 1, 1, 1, 1, 1, 1 mg/kg on Days 1, 29, 57, 85, 113, 141
|
AK002 3 mg/kg
n=91 Participants
Patients randomized to 1, 3, 3, 3, 3, 3 mg/kg on Days 1, 29, 57, 85, 113, 141
|
Placebo
n=92 Participants
Patients randomized to placebo on Days, 1, 29, 57, 85, 113, 141
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=93 Participants
|
29 years
n=4 Participants
|
32 years
n=27 Participants
|
32 years
n=483 Participants
|
|
Age, Customized
<18 years
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Age, Customized
>=18 years
|
76 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
225 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
103 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
173 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
248 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
256 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
267 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Baseline Esophageal Eosinophil Count
|
61.2 Eosinophils/HPF
STANDARD_DEVIATION 35.3 • n=93 Participants
|
58.9 Eosinophils/HPF
STANDARD_DEVIATION 32.8 • n=4 Participants
|
58.8 Eosinophils/HPF
STANDARD_DEVIATION 32.8 • n=27 Participants
|
59.7 Eosinophils/HPF
STANDARD_DEVIATION 33.6 • n=483 Participants
|
|
Dysphagia Symptom Questionnaire (DSQ) Total Score
|
36.4 Score on a scale
STANDARD_DEVIATION 12.0 • n=93 Participants
|
34.2 Score on a scale
STANDARD_DEVIATION 11.8 • n=4 Participants
|
35.2 Score on a scale
STANDARD_DEVIATION 12.1 • n=27 Participants
|
35.3 Score on a scale
STANDARD_DEVIATION 11.9 • n=483 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: Modified Intention-to-treat
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24
|
86 Participants
|
80 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Weeks 23-24Population: Modified Intention-to-treat
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24.
|
-11.9 Score on a scale
Standard Error 1.8
|
-17.4 Score on a scale
Standard Error 1.8
|
-14.6 Score on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified Intention-to-treat
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24
|
-98.9 Percentage of Change
Standard Deviation 5.6
|
-99.6 Percentage of Change
Standard Deviation 1.0
|
-3.1 Percentage of Change
Standard Deviation 76.0
|
SECONDARY outcome
Timeframe: At Week 24Population: Modified Intention-to-treat
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24
|
82 Participants
|
77 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Week 24Population: Modified Intention-to-treat
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24
|
86 Participants
|
80 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At Weeks 23-24 and Week 24, RespectivelyPopulation: Modified Intention-to-treat
Treatment responders defined by \>30% improvement in symptoms (DSQ) at Weeks 23-24 and peak intraepithelial eosinophilic count of ≤6 cells/hpf at Week 24
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Number of Treatment Responders
|
42 Participants
|
53 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 23-24Population: Modified Intention-to-treat
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Subjects Who Achieve >50% Reduction in DSQ Score From Baseline to Weeks 23-24
|
40 Participants
|
48 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 23-24Population: Modified Intention-to-treat
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Percent Change in DSQ Score From Baseline to Weeks 23-24
|
-36.3 Percentage of Change
Standard Deviation 51.4
|
-56.2 Percentage of Change
Standard Deviation 39.8
|
-36.2 Percentage of Change
Standard Deviation 82.5
|
SECONDARY outcome
Timeframe: Baseline to Weeks 23-24Population: Modified Intention-to-treat
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 1-2
|
-4.2 Score on a Scale
Standard Deviation 9.0
|
-6.5 Score on a Scale
Standard Deviation 9.9
|
-6.2 Score on a Scale
Standard Deviation 10.1
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 9-10
|
-10.5 Score on a Scale
Standard Deviation 14.5
|
-14.7 Score on a Scale
Standard Deviation 14.7
|
-13.6 Score on a Scale
Standard Deviation 13.4
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 11-12
|
-11.1 Score on a Scale
Standard Deviation 14.4
|
-15.0 Score on a Scale
Standard Deviation 14.0
|
-13.3 Score on a Scale
Standard Deviation 14.7
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 13-14
|
-11.7 Score on a Scale
Standard Deviation 15.0
|
-16.5 Score on a Scale
Standard Deviation 14.6
|
-15.0 Score on a Scale
Standard Deviation 14.4
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 15-16
|
-11.4 Score on a Scale
Standard Deviation 15.8
|
-17.0 Score on a Scale
Standard Deviation 14.8
|
-13.5 Score on a Scale
Standard Deviation 15.6
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 17-18
|
-12.4 Score on a Scale
Standard Deviation 15.6
|
-17.5 Score on a Scale
Standard Deviation 14.4
|
-14.4 Score on a Scale
Standard Deviation 15.8
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 19-20
|
-12.1 Score on a Scale
Standard Deviation 15.6
|
-17.8 Score on a Scale
Standard Deviation 14.5
|
-14.8 Score on a Scale
Standard Deviation 17.0
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 23-24
|
-12.1 Score on a Scale
Standard Deviation 15.0
|
-18.0 Score on a Scale
Standard Deviation 14.7
|
-14.6 Score on a Scale
Standard Deviation 17.5
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 3-4
|
-7.2 Score on a Scale
Standard Deviation 10.9
|
-8.4 Score on a Scale
Standard Deviation 12.4
|
-8.1 Score on a Scale
Standard Deviation 11.3
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 5-6
|
-8.4 Score on a Scale
Standard Deviation 12.9
|
-11.5 Score on a Scale
Standard Deviation 14.1
|
-11.7 Score on a Scale
Standard Deviation 12.0
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 7-8
|
-10 Score on a Scale
Standard Deviation 13.6
|
-12.2 Score on a Scale
Standard Deviation 13.8
|
-12.0 Score on a Scale
Standard Deviation 14.5
|
|
Change in Biweekly Mean DSQ Over Time Using MMRM
Weeks 21-22
|
-12.4 Score on a Scale
Standard Deviation 14.7
|
-17.6 Score on a Scale
Standard Deviation 15.0
|
-15.7 Score on a Scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Modified Intention-to-treat
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Outcome measures
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 Participants
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 Participants
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From Baseline to Week 24
|
-1.3 Score on a scale
Standard Deviation 3.2
|
-1.0 Score on a scale
Standard Deviation 3.9
|
-1.5 Score on a scale
Standard Deviation 3.8
|
Adverse Events
1 mg/kg of Lirentelimab (AK002)
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
3 mg/kg of Lirentelimab (AK002)
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 participants at risk
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 participants at risk
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 participants at risk
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
1.1%
1/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
|
Eye disorders
Eye swelling
|
0.00%
0/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
1.1%
1/92 • Baseline up to Day 197
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
1.1%
1/92 • Baseline up to Day 197
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
1/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
|
Immune system disorders
Angioedema
|
0.00%
0/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
1.1%
1/92 • Baseline up to Day 197
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/93 • Baseline up to Day 197
|
1.1%
1/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/93 • Baseline up to Day 197
|
2.2%
2/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.1%
1/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
|
Skin and subcutaneous tissue disorders
Lip swelling
|
0.00%
0/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
1.1%
1/92 • Baseline up to Day 197
|
|
Vascular disorders
Epistaxis
|
1.1%
1/93 • Baseline up to Day 197
|
0.00%
0/91 • Baseline up to Day 197
|
0.00%
0/92 • Baseline up to Day 197
|
Other adverse events
| Measure |
1 mg/kg of Lirentelimab (AK002)
n=93 participants at risk
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
3 mg/kg of Lirentelimab (AK002)
n=91 participants at risk
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
|
Placebo
n=92 participants at risk
Subjects in this arm will receive 6 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
4/93 • Number of events 4 • Baseline up to Day 197
|
4.4%
4/91 • Number of events 6 • Baseline up to Day 197
|
8.7%
8/92 • Number of events 12 • Baseline up to Day 197
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/93 • Number of events 1 • Baseline up to Day 197
|
5.5%
5/91 • Number of events 6 • Baseline up to Day 197
|
7.6%
7/92 • Number of events 8 • Baseline up to Day 197
|
|
General disorders
Fatigue
|
3.2%
3/93 • Number of events 7 • Baseline up to Day 197
|
3.3%
3/91 • Number of events 3 • Baseline up to Day 197
|
5.4%
5/92 • Number of events 6 • Baseline up to Day 197
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.8%
24/93 • Number of events 36 • Baseline up to Day 197
|
36.3%
33/91 • Number of events 41 • Baseline up to Day 197
|
12.0%
11/92 • Number of events 27 • Baseline up to Day 197
|
|
Investigations
Blood creatine phosphokinase increased
|
6.5%
6/93 • Number of events 6 • Baseline up to Day 197
|
1.1%
1/91 • Number of events 1 • Baseline up to Day 197
|
2.2%
2/92 • Number of events 2 • Baseline up to Day 197
|
|
Nervous system disorders
Headache
|
8.6%
8/93 • Number of events 17 • Baseline up to Day 197
|
7.7%
7/91 • Number of events 12 • Baseline up to Day 197
|
6.5%
6/92 • Number of events 8 • Baseline up to Day 197
|
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