Evidence map›Paper›PMID 32415720›Full record

Trial reportBritish journal of clinical pharmacology2020

The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis.

Ivo Nnane, Bart Frederick, Zhenling Yao, Donald Raible, Cathye Shu, Philipp Badorrek, Maarten van den Boer, Patrick Branigan, Karen Duffy, Frédéric Baribaud and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02345928 (A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT02345928 phase1completednot on this map

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2017Enrolled108ConditionsAsthma, Atopic Dermatitis, HealthyArmsPart 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2 (Atopic Dermatitis): CNTO 7160, Part 1 and Part 2: Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 36 citations in OpenAlex.

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  7. IL-31/33 Axis in Atopic Dermatitis.International journal of molecular sciences · 2025
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  10. Targeting alarmins in asthma: From bench to clinic.The Journal of allergy and clinical immunology · 2025
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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

13 authors at 4 institutions in 3 countries.

Ivo NnaneJanssen Research & Development, LLC, Spring House, PA, USA.
Bart FrederickJanssen Research & Development, LLC, Spring House, PA, USA.
Zhenling YaoJanssen Research & Development, LLC, Spring House, PA, USA.
Donald RaibleJanssen Research & Development, LLC, Spring House, PA, USA.
Cathye ShuJanssen Research & Development, LLC, Spring House, PA, USA.
Philipp BadorrekFraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Clinical Airway Research, Nikolai-Fuchs-Strasse 1, Hannover, 30625, Germany.
Maarten van den BoerJanssen Research & Development, LLC, Merksem, Belgium.
Patrick BraniganJanssen Research & Development, LLC, Spring House, PA, USA.
Karen DuffyJanssen Research & Development, LLC, Spring House, PA, USA.
Frédéric BaribaudJanssen Research & Development, LLC, Spring House, PA, USA.
Damien FinkJanssen Research & Development, LLC, Spring House, PA, USA.
Tong-Yuan YangJanssen Research & Development, LLC, Spring House, PA, USA.
Zhenhua XuJanssen Research & Development, LLC, Spring House, PA, USA.
Janssen (United States) · USSpringhouse · USFraunhofer Institute for Toxicology and Experimental Medicine · DEJanssen (Belgium) · BE

Funding

Janssen Research and Development
6 · The paper itself

Abstract

aimsTo assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of CNTO 7160, an anti-interleukin-33 receptor (IL-33R) monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis (AD).

methodsIn Part 1 of this Phase I, randomized, double-blind, placebo-controlled study, healthy subjects (n = 68) received single ascending intravenous (IV) CNTO 7160 dose (0.001 to 10 mg/kg) or placebo. In Part 2, patients with mild asthma (n = 24) or mild AD (n = 15) received 3 biweekly IV CNTO 7160 doses (3 or 10 mg/kg) or placebo.

resultsCNTO 7160 was generally well tolerated, with 1 serious adverse event of severe cellulitis reported (AD, CNTO 7160, 3 mg/kg). CNTO 7160 exhibited nonlinear PK (0.01-10 mg/kg). Mean clearance decreased with increasing dose (2.43 to 18.03 mL/d/kg). CNTO 7160 PK was similar between healthy subjects and patients with asthma or AD (3 or 10 mg/kg). Free sIL-33R suppression was rapid and dose dependent. Ex vivo inhibition of p38 phosphorylation of basophils was dose-dependent (1-10 mg/kg) and sustained inhibition (≥75%) was observed at higher doses (3 or 10 mg/kg). PK/PD modelling and simulation suggests that 1 mg/kg IV every 2 weeks provides adequate systemic drug exposure for sustained inhibition of p38 phosphorylation of basophils. Despite confirmation of target engagement, no apparent CNTO 7160 clinical activity was observed in patients (asthma or AD).

conclusionThis first-in-human study provides PK, PD and safety data, supporting further clinical investigation of CNTO 7160 in patients with asthma and AD.

Indexed as

Antibodies, MonoclonalAsthmaDermatitis, AtopicInterleukin-1 Receptor-Like 1 ProteinDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansAntibodies, MonoclonalInterleukin-1 Receptor-Like 1 Proteinasthmaatopic dermatitisCNTO 7160interleukin-33 receptormonoclonal antibodypharmacodynamics

Identifiers

PMID32415720
PMCPMC7688540
OpenAlexW3025842931

What OpenQuestion holds

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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.