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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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This is a multicenter, randomized, open-label, parallel-group study designed to assess healthcare provider and subject/caregiver reported functionality and performance of a single-use accessorized pre-filled syringe (APFS) or autoinjector (AI) with a fixed 210 mg dose of tezepelumab administered subcutaneously in the clinic and in an at-home setting.
The study will consist of a screening/run-in period of up to 2 weeks and a treatment period of 24 weeks, followed by a post-treatment follow-up period of 12 weeks. During the treatment period, one dose of 210 mg tezepelumab will be administered via a single-use APFS or AI subcutaneously (SC) every 4 weeks (Q4W) starting at Visit 2 (Week 0) until Visit 7 (Week 20). Subjects will be administered tezepelumab at the site during Visits 2 (Week 0), 3 (Week 4), 4 (Week 8) and 7 (Week 20). At-home administration of tezepelumab will occur during Visit 5 (Week 12) and Visit 6 (Week 16). Each device will be assessed separately using descriptive presentations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tezepelumab (AI) | Experimental | Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device. |
|
| Tezepelumab (APFS) | Experimental | Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tezepelumab (APFS) | Biological | Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Successful administration is defined as an injection completed, based on a used/returned (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned/evaluated devices. | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Devices that passed functional tests and visual inspection and showed no evidence of malfunction will be evaluated as functional. Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sady A Alpizar, MD | Clinical Research Trials of Florida, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hoover | Alabama | 35244 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33907423 | Derived | Alpizar S, Megally A, Chen C, Raj A, Downie J, Colice G. Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma. J Asthma Allergy. 2021 Apr 19;14:381-392. doi: 10.2147/JAA.S305114. eCollection 2021. |
| Label | URL |
|---|---|
| Statistical Analysis Plan (SAP) | View source |
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216 subjects randomized to tezepelumab 210 mg Q4W via APFS and tezepelumab 210 mg Q4W via AI. All randomized subjects were treated. 111 (51.4%) were randomized to tezepelumab 210 mg Q4W via APFS and 105 (48.6%) were randomized to tezepelumab 210 mg Q4W via AI.
216 subjects randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teze 210 mg Q4W Via APFS | Accessorized pre-filled syringe every 4 weeks administered subcutaneously |
| FG001 | Teze 210 mg Q4W Via AI | Autoinjector every 4 weeks administered subcutaneously |
| 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 | Yes | No | No | Study Protocol | Jul 3, 2019 | May 21, 2021 |
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Subjects will be randomized 1:1 to either an accessorized pre-filled syringe or an autoinjector. Both will be administered 210 mg tezepelumab subcutaneously.
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| Tezepelumab (AI) | Biological | Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device. |
|
| Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 |
| Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Performance is measured by the proportion of APFS or AI devices that have been reported as malfunctioning (i.e. via Product Complaints). Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4. | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 |
| Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. | Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 |
| Serum Trough Concentrations | PK serum samples were collected pre-dose on dosing visits | Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT) |
| Anti-drug Antibodies (ADA) | Anti-drug antibodies (ADA) responses at baseline and/or post baseline. Treatment-induced ADA positive is defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive is defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following IP administration. Treatment-emergent ADA (TE-ADA) positive is defined as either treatment-induced ADA positive or treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. Persistently positive is defined as ADA positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive | Pre-treatment on dosing days until end of follow-up (Week 36) per protocol |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Research Site | Northridge | California | 91324 | United States |
| Research Site | Palm Desert | California | 92260 | United States |
| Research Site | Westminster | California | 92683 | United States |
| Research Site | Tampa | Florida | 33607 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Northfield | New Jersey | 08225 | United States |
| Research Site | Cincinnati | Ohio | 45231 | United States |
| Research Site | Edmond | Oklahoma | 73034 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Dallas | Texas | 75235 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | San Antonio | Texas | 78221 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Calgary | Alberta | T2N 1N4 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Mississauga | Ontario | L5A 3V4 | Canada |
| Research Site | Ottawa | Ontario | K1G 6C6 | Canada |
| Research Site | Windsor | Ontario | N8X 2G1 | Canada |
| Research Site | Montreal | Quebec | H3G 1L5 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Research Site | Chūōku | 103-0027 | Japan |
| Research Site | Fukuoka | 811-1394 | Japan |
| Research Site | Bialystok | 15-430 | Poland |
| Research Site | Krakow | 31-011 | Poland |
| Research Site | Poznan | 60-685 | Poland |
| Research Site | Poznan | 60-693 | Poland |
| Research Site | Strzelce Opolskie | 47-100 | Poland |
| Research Site | Tarnów | 33-100 | Poland |
| Research Site | Wieluń | 98-300 | Poland |
| Research Site | Wroclaw | 53-301 | Poland |
| Protocol | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Teze 210 mg Q4W Via APFS | Accessorized pre-filled syringe every 4 weeks administered subcutaneously |
| BG001 | Teze 210 mg Q4W Via AI | Autoinjector every 4 weeks administered subcutaneously |
| 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 | Measure analysis population description for: Full Analysis Set | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Successful administration is defined as an injection completed, based on a used/returned (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned/evaluated devices. | Full analysis set - Include all subjects randomised to study treatment who received or attempted to receive at least one dose of investigational product, irrespective of their protocol adherence and continued participation. | Posted | Count of Participants | Participants | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 |
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| Secondary | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Devices that passed functional tests and visual inspection and showed no evidence of malfunction will be evaluated as functional. Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4. | Full analysis set - Include all subjects randomised to study treatment who received or attempted to receive at least one dose of investigational product, irrespective of their protocol adherence and continued participation. | Posted | Count of Units | Devices | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | Devices | Devices |
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| Secondary | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Performance is measured by the proportion of APFS or AI devices that have been reported as malfunctioning (i.e. via Product Complaints). Percentages have been calculated by using the number of used and returned devices at specified visit as denominator. Note: A few participants had missing devices. One participant had two AI devices at Week 4. | Full analysis set - Include all subjects randomised to study treatment who received or attempted to receive at least one dose of investigational product, irrespective of their protocol adherence and continued participation. | Posted | Count of Units | Devices | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | Devices | Devices |
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| Secondary | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. | Full Analysis Set - Include all subjects randomised to study treatment who received or attempted to receive at least one dose of investigational product, irrespective of their protocol adherence and continued participation. | Posted | Mean | Standard Deviation | Score | Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 |
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| Secondary | Serum Trough Concentrations | PK serum samples were collected pre-dose on dosing visits | PK analysis set - Includes all subjects in the full analysis set who received tezepelumab treatment and had at least one sample with one detectable serum concentration from a sample collected post-treatment that is assumed not to be affected by factors such as protocol deviations (e.g. disallowed medication or incorrect study medication received). | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT) |
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| Secondary | Anti-drug Antibodies (ADA) | Anti-drug antibodies (ADA) responses at baseline and/or post baseline. Treatment-induced ADA positive is defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive is defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following IP administration. Treatment-emergent ADA (TE-ADA) positive is defined as either treatment-induced ADA positive or treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. Persistently positive is defined as ADA positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive | Safety analysis set - Includes all subjects who received at least one dose of tezepelumab. | Posted | Count of Participants | Participants | Pre-treatment on dosing days until end of follow-up (Week 36) per protocol |
|
From first dose till end of study (Week 36)
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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 | Teze 210 mg Q4W Via APFS | Accessorized pre-filled syringe every 4 weeks administered subcutaneously | 0 | 111 | 5 | 111 | 29 | 111 |
| EG001 | Teze 210 mg Q4W Via AI | Autoinjector every 4 weeks administered subcutaneously | 0 | 105 | 4 | 105 | 29 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Genitourinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia escherichia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Psychogenic seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Head | AstraZeneca | +1 877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2020 | May 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000622721 | tezepelumab |
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| Adults (>=18 years) |
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| Adults (>=18 to <65 years) |
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| Adults (>=65 years) |
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| Male |
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| Black or African American |
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| Asian |
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| Not Hispanic or Latino |
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| Week 4 (in clinic) |
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| Week 8 (in clinic) |
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| Week 12 (at home) |
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| Week 16 (at home) |
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| Week 20 (in clinic) |
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| Proportion |
| 100 |
| 2-Sided |
| 95 |
| 96.65 |
| 100 |
| Other |
| Score CI | CI for Week 8 (in clinic) | Proportion | 100.0 | 2-Sided | 95 | 96.63 | 100.00 | Other |
| Score CI | CI for Week 12 (at home) | Proportion | 100.0 | 2-Sided | 95 | 96.63 | 100.00 | Other |
| Score CI | CI for Week 16 (at home) | Proportion | 95.4 | 2-Sided | 95 | 89.71 | 98.02 | Other |
| Score CI | CI for Week 20 (in clinic) | Proportion | 96.3 | 2-Sided | 95 | 90.94 | 98.56 | Other |
| Score CI | CI for Week 0 (in clinic) | Proportion | 100.0 | 2-Sided | 95 | 96.47 | 100.00 | Other |
| Score CI | CI for Week 4 (in clinic) | Proportion | 97.1 | 2-Sided | 95 | 91.93 | 99.02 | Other |
| Score CI | CI for Week 8 (in clinic) | Proportion | 98.1 | 2-Sided | 95 | 93.32 | 99.48 | Other |
| Score CI | CI for week 12 (at home) | Proportion | 99.0 | 2-Sided | 95 | 94.80 | 99.83 | Other |
| Score CI | CI for Week 16 (at home) | Proportion | 97.1 | 2-Sided | 95 | 91.93 | 99.02 | Other |
| Score CI | CI for Week 20 (in clinic) | Proportion | 97.1 | 2-Sided | 95 | 91.93 | 99.02 | Other |
| Devices |
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