Asthma
Conditions
Brief summary
This multi-center, single-arm study is designed to evaluate clinical experience of participants (or caregivers) administering lebrikizumab at home in participants with asthma. Eligible participants will receive four doses of subcutaneous (SC) lebrikizumab every 4 weeks (q4w) up to Week 12. Primary analysis visit occurs at Week 13. After study treatment, all participants will complete a 12 week safety follow up. All participants will get training for the administartion of lebrikizumab using the device.
Interventions
DRUGLebrikizumab
Lebrikizumab will be administered SC using PFS, q4w up to Week 12.
DEVICEPrefilled Syringes
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 to 75 years at Week -1 * Asthma diagnosis for greater than or equal to (\>=) 12 months prior to Week -1 * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) of \>=40% predicted at Week -1 or Week 0 (Day 1; prior to entering treatment phase), based on an established spirometry reference equations * Competent and willing, as determined by the investigator, to independently administer lebrikizumab at home. The investigator needs to confirm that the participant (or caregiver) will be able to follow the instructions to administer lebrikizumab * Able and willing to take home the pre-filled syringes of lebrikizumab at the conclusion of Week 0 (Day 1) and store these according to the requirements highlighted within the Instructions for Use (IFU) document.
Exclusion criteria
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection * Hospitalization for any reason, including acute exacerbation event, within 4 weeks prior to Week -1 or during the screening period * Infection that required hopitalization, treatment with intravenous (IV) or intramuscular antibiotics within 4 weeks and oral antibiotics within 2 weeks prior to Week -1 or during screening * Taken part in a previous clinical trial of lebrikizumab and discontinued from the trial prematurely or discontinued study drug prematurely due to an adverse event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with adherence to each planned home administration | up to Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who reported device complaints | up to Week 13 |
| Serum lebrikizumab concentration at Weeks 13 and 24 | Week 13 and 24 |
Outcome results
None listed