Evidence map›Paper›PMID 27859546›Full record

Trial reportBritish journal of clinical pharmacology2017

First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis.

Sophie Glatt, Eric Helmer, Birgit Haier, Foteini Strimenopoulou, Graham Price, Pavan Vajjah, Olivier A Harari, John Lambert, Stevan Shaw

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02529956 (A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis), which is not on this map. Cited by 58 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 4 pooled it
5.8field-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.

NCT02529956 phase1completednot on this map

A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis

TypeinterventionalSponsorUCB CelltechRan2012 to 2014Enrolled39ConditionsMild to Moderate PsoriasisArmsUCB4940, Placebo
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 4 syntheses or guidelines pooled it, 140 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

9 authors at 3 institutions in 2 countries.

Sophie GlattUCB Pharma, Slough, UK.
Eric HelmerUCB Pharma, Slough, UK.
Birgit HaierUCB Pharma, Monheim, Germany.
Foteini StrimenopoulouUCB Pharma, Slough, UK.
Graham PriceUCB Pharma, Slough, UK.
Pavan VajjahUCB Pharma, Slough, UK.
Olivier A HarariUCB Pharma, Slough, UK.
John LambertPAREXEL International, Middlesex, UK.
Stevan ShawUCB Pharma, Slough, UK.
UCB Pharma (United Kingdom) · GBPAREXEL International (United Kingdom) · GBUCB Pharma (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess safety, pharmacokinetics (PK) and clinical efficacy of bimekizumab (formerly UCB4940), a novel humanized monoclonal antibody and dual inhibitor of interleukin (IL)-17A and IL-17F, in subjects with mild plaque psoriasis.

methodsRandomized, double-blind, first-in-human study of bimekizumab in 39 subjects who received single-dose intravenous bimekizumab (8-640 mg) or placebo (NCT02529956).

resultsBimekizumab demonstrated dose-proportional linear PK and was tolerated across the dose range assessed. No subject discontinued due to treatment-emergent adverse events and no severe adverse events were reported. Bimekizumab demonstrated fast onset of clinically-meaningful effects on skin of patients with mild psoriasis as early as Week 2. Maximal improvements (100% or near 100% reductions from baseline) in all measures of disease activity were observed between Weeks 8-12 in subjects receiving 160-640 mg bimekizumab. The duration of effect at doses ≥160 mg was evident up to Weeks 12-20 after a single intravenous dose, dependent on endpoint.

conclusionsThis is the first study to demonstrate the safety, tolerability and clinical efficacy of a dual IL-17A and IL-17F inhibitor, in subjects with mild psoriasis. Bimekizumab showed fast onset of clinically-meaningful efficacy by Week 2, with a maximal or near-maximal magnitude of response that was maintained up to study Weeks 12-20. These findings support the continued clinical development of bimekizumab for diseases mediated by both IL-17A and IL-17F, including psoriasis.

Indexed as

Administration, IntravenousAdultAgedAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInterleukin-17MaleMiddle AgedPsoriasisSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedbimekizumabIL17A protein, humanIL17F protein, humanInterleukin-17anti-IL17Aanti-IL17Fbimekizumabinterleukin-17psoriasisUCB4940

Identifiers

PMID27859546
PMCPMC5401985
OpenAlexW2550814440

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.