Evidence map›Paper›PMID 31179008›Full record

ArticleBMJ open respiratory research2019

Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2).

Toby M Maher, Michael Kreuter, David J Lederer, Kevin K Brown, Wim Wuyts, Nadia Verbruggen, Simone Stutvoet, Ann Fieuw, Paul Ford, Walid Abi-Saab and 1 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
11.0field-weighted citation impact, top 1% 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.

NCT03711162 phase3terminatednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2018 to 2021Enrolled525ConditionsIdiopathic Pulmonary FibrosisArmsGLPG1690, Placebo
NCT03733444 phase3terminatednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2018 to 2021Enrolled781ConditionsIdiopathic Pulmonary FibrosisArmsGLPG1690, Placebo
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 100 citations in OpenAlex.

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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

11 authors at 7 institutions in 5 countries.

Toby M MaherNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.ORCID 0000-0001-7192-9149
Michael KreuterCentre for Interstitial and Rare Lung Diseases, Thoraxklinik, University Hospital Heidelberg, and German Center for Lung Research, Heidelberg, Germany.
David J LedererDepartment of Medicine, Columbia University Irving Medical Center, New York City, New York, USA.
Kevin K BrownDepartment of Medicine, National Jewish Health, Denver, Colorado, USA.
Wim WuytsUnit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium.
Nadia VerbruggenGalapagos NV, Mechelen, Belgium.
Simone StutvoetGalapagos NV, Mechelen, Belgium.
Ann FieuwGalapagos NV, Mechelen, Belgium.
Paul FordGalapagos NV, Mechelen, Belgium.
Walid Abi-SaabGalapagos NV, Mechelen, Belgium.
Marlies WijsenbeekDepartment of Respiratory Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.
Galapagos (Belgium) · BEColumbia University Irving Medical Center · USErasmus MC · NLHeidelberg University · DEInterstitial Cystitis Association · USNational Jewish Health · USRoyal Brompton Hospital · GB

Funding

HSRD VA CDA 13-017
6 · The paper itself

Abstract

Introduction: While current standard of care (SOC) for idiopathic pulmonary fibrosis (IPF) slows disease progression, prognosis remains poor. Therefore, an unmet need exists for novel, well-tolerated agents that reduce lung function decline and improve quality of life. Here we report the design of two phase III studies of the novel IPF therapy, GLPG1690. Methods and analysis: Two identically designed, phase III, international, randomised, double-blind, placebo-controlled, parallel-group, multicentre studies (ISABELA 1 and 2) were initiated in November 2018. It is planned that, in each study, 750 subjects with IPF will be randomised 1:1:1 to receive oral GLPG1690 600 mg, GLPG1690 200 mg or placebo, once daily, on top of local SOC, for at least 52 weeks. The primary endpoint is rate of decline of forced vital capacity (FVC) over 52 weeks. Key secondary endpoints are week 52 composite endpoint of disease progression or all-cause mortality (defined as composite endpoint of first occurrence of ≥10% absolute decline in per cent predicted FVC or all-cause mortality at week 52); time to first respiratory-related hospitalisation until end of study; and week 52 change from baseline in the St George's Respiratory Questionnaire total score (a quality-of-life measure). Ethics and dissemination: Studies will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and local ethical and legal requirements. Results will be reported in a peer-reviewed publication. Trial registration numbers: NCT03711162; NCT03733444.

Indexed as

AdultClinical Trials, Phase III as TopicDisease ProgressionDouble-Blind MethodFemaleHumansIdiopathic Pulmonary FibrosisImidazolesLysophospholipase DMalePhosphoric Diester HydrolasesPlacebosPyrimidinesQuality of LifeRandomized Controlled Trials as TopicResearch DesignGLPG1690ImidazolesLysophospholipase DPhosphoric Diester HydrolasesPlacebosPyrimidinesinterstitial fibrosisrare lung diseases

Identifiers

PMID31179008
PMCPMC6530501
OpenAlexW2946186353

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.