Phase 3
Completed N=216
Tezepelumab Home Use Study
Source: ClinicalTrials.gov NCT03968978 ↗Enrolled (actual)
216
Serious AEs
4.2%
Results posted
Jul 2021
Primary outcomePrimary: Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type — 109; 105; 111; 102 Participants
◆ Published Evidence
Established
24citations · ~5 / year
Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma.
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.
Linked Publications
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Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type |
109; 105; 111; 102; 110; 103 | — |
| SECONDARY Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction |
109; 105; 111; 103; 110; 103 | — |
| SECONDARY Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints) |
2; 0; 0; 3; 0; 2 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score |
2.227; 2.081; 1.629; 1.492; -0.598; -0.589 | — |
| SECONDARY Serum Trough Concentrations |
NA; NA; 10.9764; 10.5690; 18.9653; 20.3206 | — |
| SECONDARY Anti-drug Antibodies (ADA) |
2; 11; 2; 8; 2; 8 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03968978) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.