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

Asthma Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02546869
• Other study ID #: WB29906
• Status: Withdrawn
• Phase: Phase 3
• First received: September 7, 2015
• Last updated: April 23, 2018
• Start date: September 29, 2015
• Est. completion date: June 29, 2016

Study information

• Verified date: April 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 29, 2016
• Est. primary completion date: June 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Lebrikizumab
Lebrikizumab will be administered SC using PFS, q4w up to Week 12.

Device:
• Prefilled Syringes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adherence to each planned home administration		up to Week 13
Secondary	Percentage of participants who reported device complaints		up to Week 13
Secondary	Serum lebrikizumab concentration at Weeks 13 and 24		Week 13 and 24