Evidence map›Paper›PMID 32909660›Full record

Trial reportClinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2020

A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER).

Cary D Austin, Melissa Gonzalez Edick, Ronald E Ferrando, Margaret Solon, Miriam Baca, Kathryn Mesh, Peter Bradding, Gail M Gauvreau, Kaharu Sumino, J Mark FitzGerald and 17 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02099656 (A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02099656 phase2completednot on this map

A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2016Enrolled64ConditionsAsthmaArmsLebrikizumab, Placebo, Inhaled corticposteroids (ICS), Second Asthma Controller Medication
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  7. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER).Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2020
    Trial
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  16. Promising treatment biomarkers in asthma.Frontiers in drug safety and regulation · 2023
    Review
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  18. Asthma remission: what is it and how can it be achieved?The European respiratory journal · 2022
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  19. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 9 institutions in 5 countries.

Cary D AustinGenentech, Inc., South San Francisco, CA, USA.ORCID 0000-0002-5388-7413
Melissa Gonzalez EdickGenentech, Inc., South San Francisco, CA, USA.
Ronald E FerrandoGenentech, Inc., South San Francisco, CA, USA.
Margaret SolonGenentech, Inc., South San Francisco, CA, USA.
Miriam BacaGenentech, Inc., South San Francisco, CA, USA.
Kathryn MeshGenentech, Inc., South San Francisco, CA, USA.
Peter BraddingUniversity of Leicester and Glenfield Hospital, Leicester, UK.
Gail M GauvreauMcMaster University, Hamilton, ON, Canada.ORCID 0000-0002-6187-2385
Kaharu SuminoWashington University School of Medicine in St. Louis, St Louis, MO, USA.
J Mark FitzGeraldUniversity of British Columbia, Vancouver, BC, Canada.
Elliot IsraelBrigham and Women's Hospital, Boston, MA, USA.
Lief BjermerSkåne University Hospital, Lund, Sweden.
Arnaud BourdinCHU de Montpellier, Montpellier, France.ORCID 0000-0002-4645-5209
Joseph R ArronGenentech, Inc., South San Francisco, CA, USA.
David F ChoyGenentech, Inc., South San Francisco, CA, USA.
Julie K OlssonGenentech, Inc., South San Francisco, CA, USA.
Francis AbreuGenentech, Inc., South San Francisco, CA, USA.
Monet HowardGenentech, Inc., South San Francisco, CA, USA.
Kit WongGenentech, Inc., South San Francisco, CA, USA.
Fang CaiGenentech, Inc., South San Francisco, CA, USA.
Kun PengGenentech, Inc., South San Francisco, CA, USA.
Wendy S PutnamGenentech, Inc., South San Francisco, CA, USA.
Cécile T J HolwegGenentech, Inc., South San Francisco, CA, USA.
John G MatthewsGenentech, Inc., South San Francisco, CA, USA.
Monica KraftUniversity of Arizona College of Medicine, Tucson, AZ, USA.
Prescott G WoodruffSan Francisco Medical Center, University of California, San Francisco, CA, USA.
CLAVIER Investigators
Brigham and Women's Hospital · USCentre Hospitalier Universitaire de Montpellier · FRMcMaster University · CASkåne University Hospital · SEUniversity of Arizona · USUniversity of British Columbia · CAUniversity of California, San Francisco · USUniversity of Leicester · GBWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe anti-interleukin 13 (IL-13) monoclonal antibody lebrikizumab improves lung function in patients with moderate-to-severe uncontrolled asthma, but its effects on airway inflammation and remodelling are unknown. CLAVIER was designed to assess lebrikizumab's effect on eosinophilic inflammation and remodelling.

objectiveTo report safety and efficacy results from enrolled participants with available data from CLAVIER.

methodsWe performed bronchoscopy on patients with uncontrolled asthma before and after 12 weeks of randomized double-blinded treatment with lebrikizumab (n = 31) or placebo (n = 33). The pre-specified primary end-point was relative change in airway subepithelial eosinophils per mm

resultsThere was a baseline imbalance in tissue eosinophils and high variability between treatment groups. There was no discernible change in adjusted mean subepithelial eosinophils/mm CONCLUSIONS & CLINICAL RELEVANCE: We did not observe reduced tissue eosinophil numbers in association with lebrikizumab treatment. However, in pre-specified exploratory analyses, lebrikizumab treatment was associated with reduced degree of subepithelial fibrosis, a feature of airway remodelling, as well as improved lung function and reduced key pharmacodynamic biomarkers in bronchial tissues. These results reinforce the importance of IL-13 in airway pathobiology and suggest that neutralization of IL-13 may reduce asthmatic airway remodelling. CLINICAL

trial registrationNCT02099656.

Indexed as

AdolescentAdultAgedAirway RemodelingAnti-Asthmatic AgentsAntibodies, MonoclonalAsthmaDouble-Blind MethodEosinophilsFemaleHumansInterleukin-13LungMaleMiddle AgedSignal TransductionAnti-Asthmatic AgentsAntibodies, MonoclonalIL13 protein, humanInterleukin-13lebrikizumab

Identifiers

PMID32909660
PMCPMC7756263
OpenAlexW3085699414

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.