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Be Part of Research - Trial Details - A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma

A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Participants With Uncontrolled Asthma

Completed

Open to: ALL

Age: 18.0 - 75.0

9.1 Mile Away

Medical Conditions

Asthma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2014 Oct 2016

Publications

"Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4."; "32909660"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.

Intervention Arm Group : Lebrikizumab;

Intervention Type : DRUG
Intervention Description : Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.

Intervention Arm Group : Lebrikizumab;Placebo;

Intervention Type : DRUG
Intervention Description : Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.

Intervention Arm Group : Lebrikizumab;Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Mary's Hospital
    London
    W2 1NY
  • Glenfield Hospital
    Leicester
    LE3 9QP
  • Queen's University Belfast; NICRN Respiratory Research Office
    Belfast
    BT9 7AB
  • The Medicines Evaluation Unit
    Manchester
    M23 9QZ


The study is sponsored by Hoffmann-La Roche




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Read full details for Trial ID: NCT02099656
Last updated 04 September 2017

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