Evidence map›Paper›PMID 39884759›Full record

Trial reportThe European respiratory journal2025

A proof-of-mechanism trial in asthma with lunsekimig, a bispecific NANOBODY molecule.

Annemie Deiteren, Emmanuel Krupka, Lieselot Bontinck, Karine Imberdis, Griet Conickx, Selcuk Bas, Naimish Patel, Heribert W Staudinger, Benjamin T Suratt

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05366764 (A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SAR443765 in Healthy Adult Participants and of a Single Dose of SAR443765 in Participants With Mild-to-moderate Asthma), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT05366764 phase1completednot on this map

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SAR443765 in Healthy Adult Participants and of a Single Dose of SAR443765 in Participants With Mild-to-moderate Asthma

TypeinterventionalSponsorSanofiRan2022 to 2023Enrolled36ConditionsAsthmaArmsSAR443765, Placebo, Salbutamol or levosalbutamol
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review
  7. Nanobodies targeting SARS-CoV-2 variants.Acta pharmaceutica Sinica. B · 2026
    Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Annemie DeiterenSanofi, Ghent, Belgium annemie.deiteren@sanofi.com.
Emmanuel KrupkaSanofi, Montpellier, France.
Lieselot BontinckSanofi, Ghent, Belgium.
Karine ImberdisSanofi, Montpellier, France.
Griet ConickxSanofi, Ghent, Belgium.
Selcuk BasCharité Research Organisation, Berlin, Germany.
Naimish PatelCRISPR Therapeutics, Boston, MA, USA.
Heribert W StaudingerSanofi, Bridgewater, NJ, USA.
Benjamin T SurattSanofi, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonovalent biologics blocking thymic stromal lymphopoietin (TSLP) or interleukin (IL)-13 have been shown to elicit pharmacodynamic responses in asthma following a single dose. Therefore, dual blockade of these cytokines may result in an enhanced response compared to single targeting and has the potential to break efficacy ceilings in asthma. This study assessed the safety and tolerability of lunsekimig, a bispecific NANOBODY molecule that blocks TSLP and IL-13, and its effect on type 2 (T2) inflammatory biomarkers and lung function in asthma.

methodsThis was a phase 1b, single-dose (subcutaneous lunsekimig 400 mg or placebo), randomised (2:1), double-blind, proof-of-mechanism study in 36 participants with mild-to-moderate asthma and elevated exhaled nitric oxide fraction (

resultsLunsekimig was well tolerated, with no serious treatment-emergent adverse events.

conclusionsA single dose of lunsekimig was well tolerated, significantly suppressed T2 inflammation and improved lung function in mild-to-moderate asthma.

Indexed as

Antibodies, BispecificAsthmaSingle-Domain AntibodiesAdultAgedBiomarkersCytokinesDouble-Blind MethodFemaleHumansInterleukin-13MaleMiddle AgedNitric OxideProof of Concept StudyThymic Stromal LymphopoietinAntibodies, BispecificBiomarkersCytokinesInterleukin-13Nitric OxideSingle-Domain AntibodiesThymic Stromal Lymphopoietin

Identifiers

PMID39884759
PMCPMC12018761

What OpenQuestion 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 OpenQuestion graph.