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This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.0 mg/kg of Lirentelimab (AK002) | Experimental | Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lirentelimab | Drug | Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Adverse events assessed using the CTCAE version 5.0. | Through study completion, up to 21 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Tissue Eosinophil Responders | 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. | At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET) |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Patterson, MD | Allakos Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allakos Investigational Site 216-068 | Birmingham | Alabama | 35209 | United States | ||
| Allakos Investigational Site 216-002 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2022 |
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|
| Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline | 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. | Main Study Baseline to Extension Weeks 71-72 |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| Allakos Investigational Site 216-035 | Phoenix | Arizona | 85018 | United States |
| Allakos Investigational Site 216-032 | Chula Vista | California | 91910 | United States |
| Allakos Investigational Site 216-014 | Santa Monica | California | 90404 | United States |
| Allakos Investigational Site 216-038 | Tustin | California | 92780 | United States |
| Allakos Investigational Site 216-049 | Walnut Creek | California | 94598 | United States |
| Allakos Investigational Site 216-034 | Aurora | Colorado | 80045 | United States |
| Allakos Investigational Site 216-063 | Brandon | Florida | 33511 | United States |
| Allakos Investigational Site 216-027 | Edgewater | Florida | 32132 | United States |
| Allakos Investigational Site 216-056 | Jacksonville | Florida | 32256 | United States |
| Allakos Investigational Site 216-013 | Miami | Florida | 33176 | United States |
| Allakos Investigational Site 216-053 | New Port Richey | Florida | 34653 | United States |
| Allakos Investigational Site 216-007 | Chicago | Illinois | 60611 | United States |
| Allakos Investigational Site 216-001 | Crowley | Louisiana | 70526 | United States |
| Allakos Investigational Site 216-026 | Boston | Massachusetts | 02111 | United States |
| Allakos Investigational Site 216-052 | Boston | Massachusetts | 02115 | United States |
| Allakos Investigational Site 216-051 | Boston | Massachusetts | 02215 | United States |
| Allakos Investigational Site 216-005 | Rochester | Minnesota | 55905 | United States |
| Allakos Investigational Site 216-042 | Kansas City | Missouri | 64108 | United States |
| Allakos Investigational Site 216-045 | Reno | Nevada | 89511 | United States |
| Allakos Investigational Site 216-025 | New York | New York | 10029 | United States |
| Allakos Investigational Site 216-020 | Chapel Hill | North Carolina | 27599 | United States |
| Allakos Investigational Site 216-048 | Durham | North Carolina | 27710 | United States |
| Allakos Investigational Site 216-050 | Winston-Salem | North Carolina | 27157 | United States |
| Allakos Investigational Site 216-031 | Cincinnati | Ohio | 45229 | United States |
| Allakos Investigational Site 216-028 | Cincinnati | Ohio | 45236 | United States |
| Allakos Investigational Site 216-044 | Mentor | Ohio | 44060 | United States |
| Allakos Investigational Site 216-021 | Philadelphia | Pennsylvania | 19104 | United States |
| Allakos Investigational Site 216-006 | Chattanooga | Tennessee | 37343 | United States |
| Allakos Investigational Site 216-003 | Chattanooga | Tennessee | 37404 | United States |
| Allakos Investigational Site 216-011 | Chattanooga | Tennessee | 37421 | United States |
| Allakos Investigational Site 216-062 | Kingsport | Tennessee | 37663 | United States |
| Allakos Investigational Site 216-022 | Austin | Texas | 78742 | United States |
| Allakos Investigational Site 216-039 | Ogden | Utah | 84405 | United States |
| Allakos Investigational Site 216-030 | Salt Lake City | Utah | 84132 | United States |
| Allakos Investigational Site 216-055 | Sandy City | Utah | 84092 | United States |
| Allakos Investigational Site 216-064 | Spokane | Washington | 99202 | United States |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 | Adverse events assessed using the CTCAE version 5.0. | Posted | Count of Participants | Participants | Through study completion, up to 21 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Proportion of Tissue Eosinophil Responders | 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. | Safety Population | Posted | Count of Participants | Participants | At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET) |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in PRO Total System Score (TSS) From AK002-016/AK002-012 Baseline | 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. | Number of participants with available data within Safety Population | Posted | Mean | Standard Deviation | score on a scale | Main Study Baseline to Extension Weeks 71-72 |
|
Through study completion, up to 21 months
NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 5.0 or most current version
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 75 | 6 | 75 | 52 | 75 |
| EG001 | 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. | 1 | 84 | 14 | 84 | 57 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Volvulus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Meningitis viral | Infections and infestations | Systematic Assessment |
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| Pelvic abscess | Infections and infestations | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Radial nerve palsy | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aortic thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroenteritis eosinophilic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Corona virus infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Coronavirus test positive | Investigations | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Allakos | 650-597-5002 | medinfo@allakos.com |
| Mar 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C535952 | Eosinophilic enteropathy |
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| ID | Term |
|---|---|
| C000654568 | AK002 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| No. of Subjects with >=1 Serious Adverse Events |
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| No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation |
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| No. of Subjects with >=1 Treatment-Related Serious Adverse Events |
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