Evidence map›Paper›PMID 34969771›Full record

ArticleBMJ open respiratory research2021

Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA

Tamera J Corte, Lisa Lancaster, Jeffrey J Swigris, Toby M Maher, Jonathan G Goldin, Scott M Palmer, Takafumi Suda, Takashi Ogura, Anne Minnich, Xiaojiang Zhan and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04308681 (A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT04308681 phase2completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis

TypeinterventionalSponsorBristol-Myers SquibbRan2020 to 2023Enrolled403ConditionsPulmonary FibrosisArmsBMS-986278 Placebo, BMS-986278
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  18. Lysophosphatidic acid receptor 1 inhibition: a potential treatment target for pulmonary fibrosis.European respiratory review : an official journal of the European Respiratory Society · 2024
    Review
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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

17 authors at 9 institutions in 3 countries.

Tamera J CorteDepartment of Respiratory Medicine, Royal Prince Alfred Hospital and Medical School, University of Sydney, Sydney, New South Wales, Australia.
Lisa LancasterDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jeffrey J SwigrisDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, Colorado, USA.ORCID 0000-0002-2643-8110
Toby M MaherDivision of Pulmonary, Critical Care and Sleep Medicine, University of Southern California, Los Angeles, California, USA.ORCID 0000-0001-7192-9149
Jonathan G GoldinDepartment of Radiological Sciences, University of California Los Angeles, Los Angeles, California, USA.
Scott M PalmerDepartment of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.
Takafumi SudaSecond Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Takashi OguraDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
Anne MinnichBristol Myers Squibb, Princeton, New Jersey, USA.
Xiaojiang ZhanBristol Myers Squibb, Princeton, New Jersey, USA.
Giridhar S TirucheraiBristol Myers Squibb, Princeton, New Jersey, USA.
Brandon ElpersBristol Myers Squibb, Princeton, New Jersey, USA.
Hong XiaoBristol Myers Squibb, Princeton, New Jersey, USA.
Hideaki WatanabeBristol Myers Squibb, Princeton, New Jersey, USA.
R Adam SmithBristol Myers Squibb, Princeton, New Jersey, USA.
Edgar D CharlesBristol Myers Squibb, Princeton, New Jersey, USA.
Aryeh FischerBristol Myers Squibb, Princeton, New Jersey, USA Aryeh.Fischer@bms.com.
Bristol-Myers Squibb (United States) · USClinical Research Institute · USHamamatsu University School of Medicine · JPKanagawa Cardiovascular and Respiratory Center · JPNational Jewish Health · USThe University of Sydney · AUUniversity of California, Los Angeles · USUniversity of Southern California · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIdiopathic pulmonary fibrosis (IPF) and non-IPF, progressive fibrotic interstitial lung diseases (PF-ILD), are associated with a progressive loss of lung function and a poor prognosis. Treatment with antifibrotic agents can slow, but not halt, disease progression, and treatment discontinuation because of adverse events is common. Fibrotic diseases such as these can be mediated by lysophosphatidic acid (LPA), which signals via six LPA receptors (LPA METHODS AND ANALYSIS: This phase 2, randomised, double-blind, placebo-controlled, parallel-group, international trial will include adults with IPF or PF-ILD. The trial will consist of a 42-day screening period, a 26-week placebo-controlled treatment period, an optional 26-week active-treatment extension period, and a 28-day post-treatment follow-up. Patients in both the IPF (n=240) and PF-ILD (n=120) cohorts will be randomised 1:1:1 to receive 30 mg or 60 mg BMS-986278, or placebo, administered orally two times per day for 26 weeks in the placebo-controlled treatment period. The primary endpoint is rate of change in per cent predicted forced vital capacity from baseline to week 26 in the IPF cohort. ETHICS AND DISSEMINATION: This study 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 NUMBER: NCT04308681.

Indexed as

Idiopathic Pulmonary FibrosisReceptors, Lysophosphatidic AcidAdultClinical Trials, Phase II as TopicHumansLysophospholipidsRandomized Controlled Trials as TopicVital Capacitylysophosphatidic acidLysophospholipidsReceptors, Lysophosphatidic Acidinterstitial fibrosis

Identifiers

PMID34969771
PMCPMC8718498
OpenAlexW4200203068

What Socratic 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 Socratic graph.