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

Phase 3

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Lebrikizumab; Device: Prefilled Syringes

• Registration Number: NCT02546869
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2015-09-29
• Primary Completion: 2016-06-29
• Study Completion: 2016-06-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lebrikizumab	Lebrikizumab	Participants will receive lebrikizumab SC using prefilled syringes (PFS), q4w up to Week 12.
Lebrikizumab	Prefilled Syringes	Participants will receive lebrikizumab SC using prefilled syringes (PFS), q4w up to Week 12.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with adherence to each planned home administration	up to Week 13

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who reported device complaints	up to Week 13
Serum lebrikizumab concentration at Weeks 13 and 24	Week 13 and 24