Trial Outcomes & Findings for A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis (NCT NCT03496571)
NCT ID: NCT03496571
Last Updated: 2024-01-19
Results Overview
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro- duodenoscopy (EGD)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Baseline to Day 99
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
1 mg/kg of AK002
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Placebo
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
Baseline characteristics by cohort
| Measure |
1 mg/kg of AK002
n=22 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Placebo
n=22 Participants
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 Years
n=5 Participants
|
41 Years
n=7 Participants
|
36 Years
n=5 Participants
|
40 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Baseline Gastrointestinal Eosinophil Count
|
101 Eosinophils/HPF
STANDARD_DEVIATION 66 • n=5 Participants
|
76 Eosinophils/HPF
STANDARD_DEVIATION 40 • n=7 Participants
|
74 Eosinophils/HPF
STANDARD_DEVIATION 46 • n=5 Participants
|
84 Eosinophils/HPF
STANDARD_DEVIATION 52 • n=4 Participants
|
|
PRO Total Symptom Score (TSS)
|
34 Score on a scale
STANDARD_DEVIATION 13 • n=5 Participants
|
33 Score on a scale
STANDARD_DEVIATION 14 • n=7 Participants
|
29 Score on a scale
STANDARD_DEVIATION 14 • n=5 Participants
|
32 Score on a scale
STANDARD_DEVIATION 14 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 99Population: Intention-to-treat
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro- duodenoscopy (EGD)
Outcome measures
| Measure |
1 mg/kg of AK002
n=22 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Combined AK002
n=43 Participants
Combined group of 1 mg/kg of AK002 and 3 mg/kg of AK002.
|
Placebo
n=22 Participants
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|---|
|
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From Baseline
|
-79 Percentage of Change
Interval -95.0 to -59.0
|
-92 Percentage of Change
Interval -100.0 to -81.0
|
-86 Percentage of Change
Interval -94.0 to -71.0
|
9 Percentage of Change
Interval -15.0 to 31.0
|
SECONDARY outcome
Timeframe: On Days 85-99 and Day 99, respectivelyPopulation: Intention-to-treat
Treatment Responders defined by \>30% improvement in TSS and a reduction of \>75% in eosinophils in gastric and/or duodenal mucosa. The eosinophil count is obtained on Day 99 and the TSS score is the average of the daily scores from Days 85-99.
Outcome measures
| Measure |
1 mg/kg of AK002
n=22 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Combined AK002
n=43 Participants
Combined group of 1 mg/kg of AK002 and 3 mg/kg of AK002.
|
Placebo
n=22 Participants
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Treatment Responders
|
13 Participants
|
14 Participants
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Days 85-99Population: Intention-to-treat
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. TSS score at the End of Study is the average of the daily scores from Days 85-99.
Outcome measures
| Measure |
1 mg/kg of AK002
n=22 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 Participants
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Combined AK002
n=43 Participants
Combined group of 1 mg/kg of AK002 and 3 mg/kg of AK002.
|
Placebo
n=22 Participants
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|---|
|
Percent Change in PRO Total Symptom Score (TSS) From Baseline
|
-42 Percentage of Change
Interval -56.0 to -28.0
|
-55 Percentage of Change
Interval -70.0 to -40.0
|
-48 Percentage of Change
Interval -58.0 to -39.0
|
-22 Percentage of Change
Interval -37.0 to -7.0
|
Adverse Events
1 mg/kg of AK002
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
3 mg/kg of AK002
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg/kg of AK002
n=22 participants at risk
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 participants at risk
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Placebo
n=22 participants at risk
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Blood and lymphatic system disorders
Iron def anemia
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
General disorders
Chest pain
|
4.5%
1/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
Other adverse events
| Measure |
1 mg/kg of AK002
n=22 participants at risk
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 1 mg/kg, and a fourth dose of 1 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
3 mg/kg of AK002
n=21 participants at risk
Subjects in this arm will receive 4 monthly doses of AK002: a first dose of 0.3 mg/kg, a second dose of 1 mg/kg, a third dose of 3 mg/kg, and a fourth dose of 3 mg/kg.
AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
|
Placebo
n=22 participants at risk
Subjects in this arm will receive 4 monthly doses of placebo.
Placebo: Placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
72.7%
16/22 • Baseline up to Day 113
|
47.6%
10/21 • Baseline up to Day 113
|
22.7%
5/22 • Baseline up to Day 113
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • Baseline up to Day 113
|
9.5%
2/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • Baseline up to Day 113
|
9.5%
2/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Baseline up to Day 113
|
9.5%
2/21 • Baseline up to Day 113
|
13.6%
3/22 • Baseline up to Day 113
|
|
General disorders
Fatigue
|
13.6%
3/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22 • Baseline up to Day 113
|
9.5%
2/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
1/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Gastroenteritis viral
|
4.5%
1/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • Baseline up to Day 113
|
4.8%
1/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Infections and infestations
Influenza
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Investigations
White blood cell count increased
|
0.00%
0/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
9.1%
2/22 • Baseline up to Day 113
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
2/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Investigations
Blood glucose increased
|
9.1%
2/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • Baseline up to Day 113
|
9.5%
2/21 • Baseline up to Day 113
|
0.00%
0/22 • Baseline up to Day 113
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.1%
2/22 • Baseline up to Day 113
|
0.00%
0/21 • Baseline up to Day 113
|
4.5%
1/22 • Baseline up to Day 113
|
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