Trial Outcomes & Findings for Tezepelumab Home Use Study (NCT NCT03968978)

Last Updated: 2021-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

216 participants

Primary outcome timeframe

Week 0, Week 4, Week 8, Week 12, Week 16, Week 20

Results posted on

2021-07-29

Participant Flow

216 subjects randomized in the study.

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.

Participant milestones

Participant milestones
Measure	Teze 210 mg Q4W Via APFS Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI Autoinjector every 4 weeks administered subcutaneously
Overall Study STARTED	111	105
Overall Study COMPLETED	110	105
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Teze 210 mg Q4W Via APFS Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI Autoinjector every 4 weeks administered subcutaneously
Overall Study Adverse Event	1	0

Baseline Characteristics

Tezepelumab Home Use Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teze 210 mg Q4W Via APFS n=111 Participants Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 Participants Autoinjector every 4 weeks administered subcutaneously	Total n=216 Participants Total of all reporting groups
Age, Continuous	48.5 Years STANDARD_DEVIATION 18.1 • n=5 Participants	45.8 Years STANDARD_DEVIATION 18.3 • n=7 Participants	47.2 Years STANDARD_DEVIATION 18.2 • n=5 Participants
Age, Customized Adolescents (>=12 to <18 years)	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Customized Adults (>=18 years)	98 Participants n=5 Participants	94 Participants n=7 Participants	192 Participants n=5 Participants
Age, Customized Adults (>=18 to <65 years)	79 Participants n=5 Participants	73 Participants n=7 Participants	152 Participants n=5 Participants
Age, Customized Adults (>=65 years)	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	52 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Race/Ethnicity, Customized White	87 Participants n=5 Participants	82 Participants n=7 Participants	169 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	99 Participants n=5 Participants	92 Participants n=7 Participants	191 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=111 Participants Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 Participants Autoinjector every 4 weeks administered subcutaneously
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 0 (in clinic)	109 Participants	105 Participants
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 4 (in clinic)	111 Participants	102 Participants
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 8 (in clinic)	110 Participants	103 Participants
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 12 (at home)	110 Participants	104 Participants
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 16 (at home)	104 Participants	102 Participants
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type Week 20 (in clinic)	105 Participants	102 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=655 Devices Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=624 Devices Autoinjector every 4 weeks administered subcutaneously
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 12 (at home)	110 Devices	104 Devices
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 16 (at home)	104 Devices	102 Devices
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 0 (in clinic)	109 Devices	105 Devices
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 4 (in clinic)	111 Devices	103 Devices
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 8 (in clinic)	110 Devices	103 Devices
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction Week 20 (in clinic)	105 Devices	102 Devices

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=655 Devices Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=624 Devices Autoinjector every 4 weeks administered subcutaneously
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 0 (in clinic)	2 Devices	0 Devices
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 4 (in clinic)	0 Devices	3 Devices
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 8 (in clinic)	0 Devices	2 Devices
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 12 (at home)	0 Devices	0 Devices
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 16 (at home)	3 Devices	0 Devices
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) Week 20 (in clinic)	1 Devices	0 Devices

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=111 Participants Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 Participants Autoinjector every 4 weeks administered subcutaneously
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 12	1.197 Score Standard Deviation 0.751	1.143 Score Standard Deviation 0.745
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	-0.938 Score Standard Deviation 0.805
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 16	1.226 Score Standard Deviation 0.845	1.171 Score Standard Deviation 0.782
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	-0.910 Score Standard Deviation 0.867
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	2.081 Score Standard Deviation 0.625
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 4	1.629 Score Standard Deviation 0.791	1.492 Score Standard Deviation 0.715
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	-0.589 Score Standard Deviation 0.694
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 8	1.401 Score Standard Deviation 0.859	1.316 Score Standard Deviation 0.744
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	-0.765 Score Standard Deviation 0.793
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 20	1.230 Score Standard Deviation 0.832	1.238 Score Standard Deviation 0.795
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	-0.843 Score Standard Deviation 0.910
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score ACQ-6 score at Week 24	1.072 Score Standard Deviation 0.755	1.140 Score Standard Deviation 0.765
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	-0.941 Score Standard Deviation 0.775

SECONDARY outcome

Timeframe: 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).

PK serum samples were collected pre-dose on dosing visits

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=111 Participants Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 Participants Autoinjector every 4 weeks administered subcutaneously
Serum Trough Concentrations Baseline (Week 0)	NA µg/mL Geometric Coefficient of Variation NA \<LLOQ (Lower Limit of Quantification)	NA µg/mL Geometric Coefficient of Variation NA \<LLOQ (Lower Limit of Quantification)
Serum Trough Concentrations Week 4	10.9764 µg/mL Geometric Coefficient of Variation 48.3948	10.5690 µg/mL Geometric Coefficient of Variation 57.0076
Serum Trough Concentrations Week 20	18.9653 µg/mL Geometric Coefficient of Variation 69.0785	20.3206 µg/mL Geometric Coefficient of Variation 56.5858
Serum Trough Concentrations Week 24 (EOT)	19.6274 µg/mL Geometric Coefficient of Variation 58.2660	19.9264 µg/mL Geometric Coefficient of Variation 54.3198

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Teze 210 mg Q4W Via APFS n=111 Participants Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 Participants Autoinjector every 4 weeks administered subcutaneously
Anti-drug Antibodies (ADA) ADA positive at baseline and/or post-baseline (ADA prevalence)	2 Participants	11 Participants
Anti-drug Antibodies (ADA) TE-ADA positive (ADA incidence)	2 Participants	8 Participants
Anti-drug Antibodies (ADA) Treatment-induced ADA positive	2 Participants	8 Participants
Anti-drug Antibodies (ADA) Treatment-boosted ADA positive	0 Participants	0 Participants
Anti-drug Antibodies (ADA) ADA persistently positive	1 Participants	7 Participants
Anti-drug Antibodies (ADA) Both baseline and at least one post-baseline ADA positive	0 Participants	2 Participants
Anti-drug Antibodies (ADA) ADA transiently positive	1 Participants	3 Participants
Anti-drug Antibodies (ADA) Only baseline ADA positive	0 Participants	1 Participants

Adverse Events

Teze 210 mg Q4W Via APFS

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

Teze 210 mg Q4W Via AI

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Teze 210 mg Q4W Via APFS n=111 participants at risk Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 participants at risk Autoinjector every 4 weeks administered subcutaneously
Gastrointestinal disorders Gastritis	0.00% 0/111 • From first dose till end of study (Week 36)	0.95% 1/105 • Number of events 1 • From first dose till end of study (Week 36)
Gastrointestinal disorders Pancreatitis acute	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Infections and infestations Diverticulitis	1.8% 2/111 • Number of events 2 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Infections and infestations Escherichia urinary tract infection	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Infections and infestations Genitourinary tract infection	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Infections and infestations Pneumonia escherichia	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Infections and infestations Varicella	0.00% 0/111 • From first dose till end of study (Week 36)	0.95% 1/105 • Number of events 1 • From first dose till end of study (Week 36)
Nervous system disorders Psychogenic seizure	0.00% 0/111 • From first dose till end of study (Week 36)	0.95% 1/105 • Number of events 1 • From first dose till end of study (Week 36)
Renal and urinary disorders Renal colic	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/111 • From first dose till end of study (Week 36)	2.9% 3/105 • Number of events 4 • From first dose till end of study (Week 36)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.90% 1/111 • Number of events 1 • From first dose till end of study (Week 36)	0.00% 0/105 • From first dose till end of study (Week 36)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/111 • From first dose till end of study (Week 36)	0.95% 1/105 • Number of events 1 • From first dose till end of study (Week 36)

Other adverse events

Other adverse events
Measure	Teze 210 mg Q4W Via APFS n=111 participants at risk Accessorized pre-filled syringe every 4 weeks administered subcutaneously	Teze 210 mg Q4W Via AI n=105 participants at risk Autoinjector every 4 weeks administered subcutaneously
Infections and infestations Nasopharyngitis	10.8% 12/111 • Number of events 13 • From first dose till end of study (Week 36)	14.3% 15/105 • Number of events 15 • From first dose till end of study (Week 36)
Infections and infestations Pharyngitis	3.6% 4/111 • Number of events 4 • From first dose till end of study (Week 36)	3.8% 4/105 • Number of events 6 • From first dose till end of study (Week 36)
Infections and infestations Upper respiratory tract infection	8.1% 9/111 • Number of events 11 • From first dose till end of study (Week 36)	7.6% 8/105 • Number of events 9 • From first dose till end of study (Week 36)
Respiratory, thoracic and mediastinal disorders Asthma	5.4% 6/111 • Number of events 9 • From first dose till end of study (Week 36)	4.8% 5/105 • Number of events 5 • From first dose till end of study (Week 36)

Additional Information

Global Clinical Head

AstraZeneca

Phone: +1 877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place