Evidence map›Paper›PMID 34523807›Full record

Trial reportClinical and translational science2022

Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials.

Matthew P Kosloski, George D Kalliolias, Christine R Xu, Sivan Harel, Ching-Ha Lai, Wenjun Zheng, John D Davis, Mohamed A Kamal

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 46 citations in OpenAlex.

  1. Trial
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  5. Article
  6. Review
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  8. A translational view of airway epithelial dysfunction in COPD.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review
  9. Targeting alarmins in asthma: From bench to clinic.The Journal of allergy and clinical immunology · 2025
    Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Exploratory pharmacodynamics and efficacy of PF-06817024 in a Phase 1 study of patients with chronic rhinosinusitis and atopic dermatitis.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Article
  18. Article
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  20. Article
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

8 authors at 2 institutions in 1 country.

Matthew P KosloskiRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
George D KallioliasRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Christine R XuSanofi, Bridgewater, New Jersey, USA.
Sivan HarelRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Ching-Ha LaiRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Wenjun ZhengRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
John D DavisRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Mohamed A KamalRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Regeneron (United States) · USSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Itepekimab is a monoclonal antibody that targets interleukin (IL-33) and has been shown to reduce airway inflammation and associated tissue damage in preclinical studies. We assessed the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamic profiles of single-ascending and multiple-ascending doses of itepekimab in two randomized, double-blind, placebo-controlled phase I studies. Healthy adults (N = 40) were randomized to the single-dose study and patients with moderate asthma (N = 23) to the multiple-dose study. Itepekimab was administered intravenously (0.3, 1, 3, or 10 mg/kg infusion) or subcutaneously (150 mg) in the single-dose study and subcutaneously (75 or 150 mg weekly for 4 weeks) in the multiple-dose study. Itepekimab exhibited linear PKs across studies and dose-proportional increases in mean maximum concentration in serum and area under the concentration-time curve following single intravenous or multiple subcutaneous doses. Itepekimab demonstrated mean subcutaneous bioavailability of 59-73% and a long terminal half-life (30.0-31.6 days). IL-33 concentrations in most healthy participants and patients with asthma were undetectable at baseline. Following administration of itepekimab in both studies, total IL-33 concentrations increased and blood eosinophils decreased, both with durable effect. Itepekimab was well-tolerated in both studies with no detection of treatment-emergent anti-drug antibody responses.

Indexed as

AsthmaAdministration, IntravenousAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeditepekimab

Identifiers

PMID34523807
PMCPMC8841494
OpenAlexW3199064513

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.