A Single-Arm Study to Evaluate Administration of Lebrikizumab by Participants or Caregivers in the Home Setting



Status:Not yet recruiting
Conditions:Asthma, Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:9/26/2015
Start Date:September 2015
End Date:June 2016
Contact:Reference Study ID Number: WB29906 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. Only)

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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.


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
We found this trial at
39
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