Evidence map›Paper›PMID 34292606›Full record

Trial reportBritish journal of clinical pharmacology2022

A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma.

Dave Singh, Rainard Fuhr, Nicholas P Bird, Sarah Mole, Kelly Hardes, Yau Lun Man, Anthony Cahn, Steven W Yancey, Isabelle J Pouliquen

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03287310 (A Randomised Double-blind), which is not on this map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
3.8field-weighted citation impact, top 5% 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.

NCT03287310 phase1completednot on this map

A Randomised Double-blind (Sponsor Open), Placebo Controlled, Single Ascending Dose, First Time in Human Study in Participants With Mild to Moderate Asthma to Assess Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3511294 Administered Subcutaneously

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2019Enrolled50ConditionsAsthmaArmsGSK3511294, Placebo, Salbutamol/albuterol
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 55 citations in OpenAlex.

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  12. Emerging Systemic Treatments for Asthma and Allergic Diseases: New Tricks, Same Dog?The journal of allergy and clinical immunology. In practice · 2026
    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

9 authors at 7 institutions in 3 countries.

Dave SinghMedicines Evaluation Unit, Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK.ORCID 0000-0001-8918-7075
Rainard FuhrEarly Phase, Parexel International, Berlin, Germany.
Nicholas P BirdBiostatistics, GSK, Stevenage, UK.ORCID 0000-0002-5977-2561
Sarah MoleDiscovery Medicine, GSK, Stevenage, Hertfordshire, UK.
Kelly HardesGlobal Clinical Science and Delivery, GSK, Brentford, Middlesex, UK.
Yau Lun ManDiscovery Medicine, GSK, Stevenage, Hertfordshire, UK.
Anthony CahnDiscovery Medicine, GSK, Stevenage, Hertfordshire, UK.
Steven W YanceyRespiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
Isabelle J PouliquenAffiliation at time of study: Clinical Pharmacology Modelling & Simulation, GSK, Brentford, Middlesex, UK.
North Hertfordshire College · GBAge UK · GBGlaxoSmithKline (Germany) · DEManchester University NHS Foundation Trust · GBMiddlesex University · GBPAREXEL International (United Kingdom) · GBResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsGSK3511294 is a humanized anti-interleukin (IL)-5 monoclonal antibody (mAb) engineered for extended half-life and improved IL-5 affinity versus other anti-IL-5 mAbs. This study examined its safety, tolerability, pharmacokinetics (PK) and effect on blood eosinophil counts.

methodsThis was a double-blind, parallel-group, single-ascending-dose, multicenter, Phase 1 study (205 722;NCT03287310) in patients with asthma and a blood eosinophil count ≥200 cells μL

resultsForty-eight patients received the study drug and completed the study. Adverse events (AEs) occurred in 92% of placebo-treated and 81% of GSK3511294-treated patients. There were no AEs leading to study withdrawal or serious AEs; hypersensitivity (one event in one patient) and injection-site reaction (three events in two patients) occurred infrequently. Marked reductions (>48%) in blood eosinophil count were seen from 24 hours post-dose with all GSK3511294 doses but not placebo; suppression was maintained for longer with increasing dose (82% and 83% adjusted reductions vs placebo with 100 and 300 mg, respectively, at week 26). PK were linear and dose proportional over the dose range; terminal half-life was 38-53 days.

conclusionsGSK3511294 was well tolerated, with linear and dose proportional PK, extended half-life and blood eosinophil count reduction, supporting less frequent dosing versus other anti-IL-5 mAbs.

Indexed as

AsthmaInterleukin-5Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodEosinophilsHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedInterleukin-5anti-interleukin-5biologic therapyeosinophilic asthmaextended pharmacologysafety

Identifiers

PMID34292606
PMCPMC9290054
OpenAlexW3186027099

What OpenQuestion holds

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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.