Asthma
Conditions
Keywords
Asthma, Severe Uncontrolled Asthma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALTezepelumab (APFS)
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
BIOLOGICALTezepelumab (AI)
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
Sponsors
Amgen
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized 1:1 to either an accessorized pre-filled syringe or an autoinjector. Both will be administered 210 mg tezepelumab subcutaneously.
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 12 to 80 years. * Documented physician-diagnosed asthma for at least 12 months. * Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 ≥ 12% AND ≥200 mL (15-60 min after administration of 4 puffs of albuterol/salbutamol), documented either: in the previous 12 months prior to V1, OR demonstrated at V1, V1A, or at V2. * Documented history of current treatment with medium- or high-dose ICS for at least 6 months and at least one additional asthma controller medication according to standard practice of care. ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. * Morning pre-BD FEV1 of \>50% predicted normal at Visit 1, Visit 1A, or Visit 2.
Exclusion criteria
* Clinically important pulmonary or systemic diseases other than asthma. * History of cancer except basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma of the cervix within 12 months prior to Visit 1. * Acute upper or lower respiratory infection requiring antibiotics or antiviral medications finalized \<2 weeks before Visit 1 or during screening/run-in period. * A helminth parasitic infection diagnosed within 6 months that is untreated or is unresponsive to the standard of care. * Smoking history of ≥10 pack years, (includes vaping and e-cigarettes) * History of chronic alcohol or drug abuse. * Tuberculosis requiring treatment within 12 months prior to V1. * History of HIV, Hepatitis B or Hepatitis C. * Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives. * Bronchial thermoplasty in 24 months prior to V1. * Anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) to any biologic therapy. * Evidence of active liver disease (e.g. jaundice, AST, ALT or ALP \>2 times upper limit of normal), ongoing liver disease or inexplicably elevated liver chemistry values. * Pregnant, breastfeeding or lactating women. * Non-leukocyte depleted whole blood transfusion in 120 days prior to visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | 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. |
| Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | 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. |
| Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24 | 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. |
| Serum Trough Concentrations | Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT) | PK serum samples were collected pre-dose on dosing visits |
| Anti-drug Antibodies (ADA) | Pre-treatment on dosing days until end of follow-up (Week 36) per protocol | 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 |
Countries
Canada, Japan, Poland, United States
Participant flow
Recruitment details
216 subjects randomized in the study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Teze 210 mg Q4W Via APFS Accessorized pre-filled syringe every 4 weeks administered subcutaneously | 111 |
| Teze 210 mg Q4W Via AI Autoinjector every 4 weeks administered subcutaneously | 105 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Teze 210 mg Q4W Via AI | Teze 210 mg Q4W Via APFS |
|---|---|---|---|
| Age, Continuous | 47.2 Years STANDARD_DEVIATION 18.2 | 45.8 Years STANDARD_DEVIATION 18.3 | 48.5 Years STANDARD_DEVIATION 18.1 |
| Age, Customized Adolescents (>=12 to <18 years) | 24 Participants | 11 Participants | 13 Participants |
| Age, Customized Adults (>=18 to <65 years) | 152 Participants | 73 Participants | 79 Participants |
| Age, Customized Adults (>=18 years) | 192 Participants | 94 Participants | 98 Participants |
| Age, Customized Adults (>=65 years) | 40 Participants | 21 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian | 31 Participants | 15 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 25 Participants | 13 Participants | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 191 Participants | 92 Participants | 99 Participants |
| Race/Ethnicity, Customized White | 169 Participants | 82 Participants | 87 Participants |
| Sex: Female, Male Female | 108 Participants | 52 Participants | 56 Participants |
| Sex: Female, Male Male | 108 Participants | 53 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 105 |
| other Total, other adverse events | 29 / 111 | 29 / 105 |
| serious Total, serious adverse events | 5 / 111 | 4 / 105 |
Outcome results
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.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 20 (in clinic) | 105 Participants |
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 4 (in clinic) | 111 Participants |
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 8 (in clinic) | 110 Participants |
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 12 (at home) | 110 Participants |
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 16 (at home) | 104 Participants |
| Teze 210 mg Q4W Via APFS | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 0 (in clinic) | 109 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 16 (at home) | 102 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 0 (in clinic) | 105 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 12 (at home) | 104 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 4 (in clinic) | 102 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 20 (in clinic) | 102 Participants |
| Teze 210 mg Q4W Via AI | Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type | Week 8 (in clinic) | 103 Participants |
95% CI: [93.67, 99.5]Score CI
95% CI: [96.65, 100]Score CI
95% CI: [96.63, 100]Score CI
95% CI: [96.63, 100]Score CI
95% CI: [89.71, 98.02]Score CI
95% CI: [90.94, 98.56]Score CI
95% CI: [96.47, 100]Score CI
95% CI: [91.93, 99.02]Score CI
95% CI: [93.32, 99.48]Score CI
95% CI: [94.8, 99.83]Score CI
95% CI: [91.93, 99.02]Score CI
95% CI: [91.93, 99.02]Score CI
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
Time frame: Pre-treatment on dosing days until end of follow-up (Week 36) per protocol
Population: Safety analysis set - Includes all subjects who received at least one dose of tezepelumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | Treatment-induced ADA positive | 2 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | ADA transiently positive | 1 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | TE-ADA positive (ADA incidence) | 2 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | Only baseline ADA positive | 0 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | Treatment-boosted ADA positive | 0 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | Both baseline and at least one post-baseline ADA positive | 0 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | ADA persistently positive | 1 Participants |
| Teze 210 mg Q4W Via APFS | Anti-drug Antibodies (ADA) | ADA positive at baseline and/or post-baseline (ADA prevalence) | 2 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | Treatment-boosted ADA positive | 0 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | ADA positive at baseline and/or post-baseline (ADA prevalence) | 11 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | TE-ADA positive (ADA incidence) | 8 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | Treatment-induced ADA positive | 8 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | ADA persistently positive | 7 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | ADA transiently positive | 3 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | Only baseline ADA positive | 1 Participants |
| Teze 210 mg Q4W Via AI | Anti-drug Antibodies (ADA) | Both baseline and at least one post-baseline ADA positive | 2 Participants |
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.
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 4 | -0.598 Score | Standard Deviation 0.702 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 16 | 1.226 Score | Standard Deviation 0.845 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 8 | -0.826 Score | Standard Deviation 0.833 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 16 | -0.986 Score | Standard Deviation 0.893 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 4 | 1.629 Score | Standard Deviation 0.791 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 20 | 1.230 Score | Standard Deviation 0.832 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 12 | 1.197 Score | Standard Deviation 0.751 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 20 | -0.978 Score | Standard Deviation 0.866 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 8 | 1.401 Score | Standard Deviation 0.859 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 24 | 1.072 Score | Standard Deviation 0.755 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 12 | -1.011 Score | Standard Deviation 0.805 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 24 | -1.141 Score | Standard Deviation 0.845 |
| Teze 210 mg Q4W Via APFS | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Baseline (Week 0) | 2.227 Score | Standard Deviation 0.732 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 24 | -0.941 Score | Standard Deviation 0.775 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Baseline (Week 0) | 2.081 Score | Standard Deviation 0.625 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 4 | 1.492 Score | Standard Deviation 0.715 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 4 | -0.589 Score | Standard Deviation 0.694 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 8 | 1.316 Score | Standard Deviation 0.744 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 8 | -0.765 Score | Standard Deviation 0.793 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 12 | 1.143 Score | Standard Deviation 0.745 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 12 | -0.938 Score | Standard Deviation 0.805 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 16 | 1.171 Score | Standard Deviation 0.782 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 16 | -0.910 Score | Standard Deviation 0.867 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 20 | 1.238 Score | Standard Deviation 0.795 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | Change from Baseline of ACQ-6 score at Week 20 | -0.843 Score | Standard Deviation 0.91 |
| Teze 210 mg Q4W Via AI | Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score | ACQ-6 score at Week 24 | 1.140 Score | Standard Deviation 0.765 |
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.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 0 (in clinic) | 2 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 4 (in clinic) | 0 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 8 (in clinic) | 0 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 12 (at home) | 0 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 16 (at home) | 3 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 20 (in clinic) | 1 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 16 (at home) | 0 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 0 (in clinic) | 0 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 12 (at home) | 0 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 4 (in clinic) | 3 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 20 (in clinic) | 0 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) | Week 8 (in clinic) | 2 Devices |
95% CI: [0, 3.37]Score CI
95% CI: [0.5, 6.33]Score CI
95% CI: [0, 3.35]Score CI
95% CI: [0, 3.37]Score CI
95% CI: [0.96, 7.92]Score CI
95% CI: [0.17, 5.15]Score CI
95% CI: [0, 3.53]Score CI
95% CI: [0.97, 7.99]Score CI
95% CI: [0.52, 6.68]Other CI
95% CI: [0, 3.56]Score CI
95% CI: [0, 3.63]Score CI
95% CI: [0, 3.63]Score CI
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.
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 0 (in clinic) | 109 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 4 (in clinic) | 111 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 8 (in clinic) | 110 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 12 (at home) | 110 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 16 (at home) | 104 Devices |
| Teze 210 mg Q4W Via APFS | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 20 (in clinic) | 105 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 16 (at home) | 102 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 0 (in clinic) | 105 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 12 (at home) | 104 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 4 (in clinic) | 103 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 20 (in clinic) | 102 Devices |
| Teze 210 mg Q4W Via AI | Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction | Week 8 (in clinic) | 103 Devices |
95% CI: [93.67, 99.5]Score CI
95% CI: [96.65, 100]Score CI
95% CI: [96.63, 100]Score CI
95% CI: [96.63, 100]Score CI
95% CI: [92.8, 99.04]Score CI
95% CI: [94.85, 99.83]Score CI
95% CI: [96.46, 100]Score CI
95% CI: [93.38, 99.48]Score CI
95% CI: [93.32, 99.48]Other CI
95% CI: [96.44, 100]Score CI
95% CI: [96.37, 100]Score CI
95% CI: [96.37, 100]Score CI
Secondary
Serum Trough Concentrations
PK serum samples were collected pre-dose on dosing visits
Time frame: Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Teze 210 mg Q4W Via APFS | Serum Trough Concentrations | Baseline (Week 0) | NA µg/mL | — |
| Teze 210 mg Q4W Via APFS | Serum Trough Concentrations | Week 4 | 10.9764 µg/mL | Geometric Coefficient of Variation 48.3948 |
| Teze 210 mg Q4W Via APFS | Serum Trough Concentrations | Week 20 | 18.9653 µg/mL | Geometric Coefficient of Variation 69.0785 |
| Teze 210 mg Q4W Via APFS | Serum Trough Concentrations | Week 24 (EOT) | 19.6274 µg/mL | Geometric Coefficient of Variation 58.266 |
| Teze 210 mg Q4W Via AI | Serum Trough Concentrations | Week 24 (EOT) | 19.9264 µg/mL | Geometric Coefficient of Variation 54.3198 |
| Teze 210 mg Q4W Via AI | Serum Trough Concentrations | Baseline (Week 0) | NA µg/mL | — |
| Teze 210 mg Q4W Via AI | Serum Trough Concentrations | Week 20 | 20.3206 µg/mL | Geometric Coefficient of Variation 56.5858 |
| Teze 210 mg Q4W Via AI | Serum Trough Concentrations | Week 4 | 10.5690 µg/mL | Geometric Coefficient of Variation 57.0076 |