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This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 to 3.0 mg/kg of AK002 | Experimental | Subjects in this arm will receive 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK002 | Drug | AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Adverse events assessed using the CTCAE version 4.03 | Through study completion, up to 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Paterson, MD | Allakos Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenician Centers for Research and Innovation | Phoenix | Arizona | 85021 | United States | ||
| Mayo Clinic Arizona |
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The participants who were enrolled in and completed the study NCT03496571 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 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. |
| 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 | Oct 18, 2021 |
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| AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months) |
| Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline | Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline | AK002-003 Baseline to Day 547 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Ventura Clinical Trials | Ventura | California | 93003 | United States |
| Advanced Research Institute | New Port Richey | Florida | 34653 | United States |
| Northwestern | Chicago | Illinois | 60611 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| NIH | Bethesda | Maryland | 20892 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Avant Research Associates | Austin | Texas | 78704 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 | Adverse events assessed using the CTCAE version 4.03 | Posted | Count of Participants | Participants | Through study completion, up to 28 months |
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| Secondary | Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline | 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. | Posted | Mean | Standard Deviation | Percentage of change | AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months) |
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| Secondary | Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline | Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline | Posted | Mean | Standard Deviation | Percentage of change | AK002-003 Baseline to Day 547 |
|
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Through study completion, up to 28 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 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. | 0 | 21 | 2 | 21 | 20 | 21 |
| EG001 | 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. | 0 | 37 | 9 | 37 | 32 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal hiernia | Gastrointestinal disorders | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutrophilia | Blood and lymphatic system disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis eosinophilic | Gastrointestinal disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | 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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| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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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 |
| Jan 17, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C535952 | Eosinophilic enteropathy |
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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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 |
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| More than one race |
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| Unknown or Not Reported |
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| Subjects with an adverse event leading to study discontinuation |
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| Subjects with ≥1 serious adverse events |
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| Subjects with ≥1 treatment-related serious adverse events |
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