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

NCT ID: NCT02546869

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2016-06-29

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.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lebrikizumab

Participants will receive lebrikizumab SC using prefilled syringes (PFS), q4w up to Week 12.

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: DRUG

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

Prefilled Syringes

Intervention Type: DEVICE

Interventions

Lebrikizumab

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

Intervention Type: DRUG

Prefilled Syringes

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

WB29906

Identifier Type: -

Identifier Source: org_study_id