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Study Complete
Sponsor ID
D5180C00011

Tezepelumab Home Use StudyPATH-HOME

Sponsor ID
D5180C00011
Clinicaltrials.gov ID
NCT03968978
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
216
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportions of HCPs and Subjects/Caregivers Who Successfully Administered Tezepelumab in Clinic or at Home by Device Type

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

Secondary Outcome Measures

Proportions of Used/Returned Devices That Pass Functional Tests and Visual Inspection and Showed no Evidence of Malfunction

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

Proportions of Devices That Have Been Reported as Malfunctioning (Product Complaints)

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

Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score

Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24

Serum Trough Concentrations

Timeframe: Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)

Anti-drug Antibodies (ADA)

Timeframe: Pre-treatment on dosing days until end of follow-up (Week 36) per protocol

Study Documents

Protocol
Available Language(s): English
Download Document(s)
Statistical Analysis Plan
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Hoover, Alabama, United States, 35244
Status
N/A
Location
Research Site
Gilbert, Arizona, United States, 85234
Status
N/A
Location
Research Site
Northridge, California, United States, 91324
Status
N/A
Location
Research Site
Palm Desert, California, United States, 92260
Status
N/A
Location
Research Site
Westminster, California, United States, 92683
Status
N/A
Location
Research Site
Tampa, Florida, United States, 33607
Status
N/A
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Study Info
Age
12 - 80 Years
Condition
  • Asthma
    • Sex
    All
    Trial Dates
    May 2019 - Jun 2020
    Inclusion and Exclusion 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 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.