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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02546869
Collaborator
(none)
0
Enrollment
1
Arm
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Sep 29, 2015
Anticipated Primary Completion Date :
Jun 29, 2016
Anticipated Study Completion Date :
Jun 29, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lebrikizumab

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

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

Device: Prefilled Syringes

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants with adherence to each planned home administration [up to Week 13]

Secondary Outcome Measures

  1. Percentage of participants who reported device complaints [up to Week 13]

  2. Serum lebrikizumab concentration at Weeks 13 and 24 [Week 13 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02546869
Other Study ID Numbers:
  • WB29906
First Posted:
Sep 11, 2015
Last Update Posted:
Apr 25, 2018
Last Verified:
Apr 1, 2018

Study Results

No Results Posted as of Apr 25, 2018