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

NCT02546869 | Withdrawn Phase 3

• 1 other identifier: WB29906
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adherence to each planned home administration

  up to Week 13

Secondary Outcomes (2)

• Percentage of participants who reported device complaints

  up to Week 13

• Serum lebrikizumab concentration at Weeks 13 and 24

  Week 13 and 24

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

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

Drug: Lebrikizumab; Device: Prefilled Syringes

Interventions

Lebrikizumab DRUG

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

Lebrikizumab

Prefilled Syringes DEVICE

Lebrikizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Asthma

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 11, 2015
• Study Start: September 29, 2015
• Primary Completion: June 29, 2016
• Study Completion: June 29, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04