AsthmaPhase 3PATH-HOMENCT03968978
Tezepelumab Home Use Study
A Phase 3 study testing Tezepelumab (APFS) and Tezepelumab (AI) in people with Asthma, run by AstraZeneca at 36 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tezepelumab (APFS) and Tezepelumab (AI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 21 May 2019to 5 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States16 sites
Research Site
Cincinnati, Ohio, 45231
Research Site
Dallas, Texas, 75235
Research Site
Edmond, Oklahoma, 73034
Research Site
Gilbert, Arizona, 85234
Research Site
Hoover, Alabama, 35244
Research Site
McKinney, Texas, 75069
Research Site
Medford, Oregon, 97504
Research Site
Northfield, New Jersey, 08225
Research Site
Northridge, California, 91324
Research Site
Omaha, Nebraska, 68114
Research Site
Palm Desert, California, 92260
Research Site
San Antonio, Texas, 78221
Research Site
San Antonio, Texas, 78229
Research Site
Savannah, Georgia, 31406
Research Site
Tampa, Florida, 33607
Research Site
Westminster, California, 92683
Canada10 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Calgary, Alberta, T2N 1N4
Research Site
Mississauga, Ontario, L5A 3V4
Research Site
Montreal, Quebec, H3G 1L5
Research Site
Ottawa, Ontario, K1G 6C6
Research Site
Québec, Quebec, G1V 4G5
Research Site
Québec, Quebec, G1V 4W2
Research Site
Trois-Rivières, Quebec, G8T 7A1
Research Site
Windsor, Ontario, N8X 2G1
Poland8 sites
Research Site
Bialystok, 15-430
Research Site
Krakow, 31-011
Research Site
Poznan, 60-685
Research Site
Poznan, 60-693
Research Site
Strzelce Opolskie, 47-100
Research Site
Tarnów, 33-100
Research Site
Wieluń, 98-300
Research Site
Wroclaw, 53-301
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma (PATH-HOME)
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Tezepelumab (APFS), Tezepelumab (AI)
- Keywords
- Asthma, Severe Uncontrolled Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tezepelumab (APFS)Biological
Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
Tezepelumab (AI)Biological
Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab (AI) | Experimental | Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device. Receives: Biological: Tezepelumab (AI) |
| Tezepelumab (APFS) | Experimental | Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS). Receives: Biological: Tezepelumab (APFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Pre-treatment on dosing days until end of follow-up (Week 36) per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start21 May 2019
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Sady A Alpizar, MD, Principal investigator, Clinical Research Trials of Florida, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968978
- Sponsor's protocol ID
- D5180C00011
- Acronym
- PATH-HOME
- Status last verified
- Jul 2021
- First submitted
- 30 Apr 2019
- Last updated
- 29 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33907423
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma (PATH-HOME)
- ClinicalTrials.gov ID
- NCT03968978
- Acronym / sponsor ID
- PATH-HOME / D5180C00011
- Conditions
- Asthma
- Keywords
- Asthma, Severe Uncontrolled Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 21 May 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 29 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab (AI) | Experimental | Biological: Tezepelumab (AI)Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device. |
| Tezepelumab (APFS) | Experimental | Biological: Tezepelumab (APFS)Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS). |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tezepelumab (APFS)Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS). | Biological | Tezepelumab (APFS) |
| Tezepelumab (AI)Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device. | Biological | Tezepelumab (AI) |
Primary outcome
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type
Time frame: 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.
5 secondary outcomes
Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
Serum Trough Concentrations
Time frame: Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
Anti-drug Antibodies (ADA)
Time frame: Pre-treatment on dosing days until end of follow-up (Week 36) per protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33907423Alpizar 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.
- Statistical Analysis Plan (SAP)Link provided by the sponsor.
- ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sady A Alpizar, MD principal investigator
Clinical Research Trials of Florida, Inc.
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tezepelumab (APFS) and Tezepelumab (AI) in people with Asthma, run by AstraZeneca at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, Poland, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type (time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.