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NCT02999711

Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

Completed Phase 1 Last updated 12 December 2018
What this trial tests

Phase 1 trial testing REGN3500 in Asthma in 23 participants. Completed in 10 September 2018.

Timeline
3 February 2017
Primary endpoint
30 August 2018
10 September 2018

Quick facts

Lead sponsorRegeneron Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment23
Start date3 February 2017
Primary completion30 August 2018
Estimated completion10 September 2018
Sites3 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

Adults 18 to 60, any sex, with Asthma or Moderate Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.
    Chinthrajah S, Cao S, Liu C, Lyu SC, et al · · 2019 · cited 127× · PMID 31723064 · DOI 10.1172/jci.insight.131347
  2. Anti-alarmins in asthma: targeting the airway epithelium with next-generation biologics.
    Porsbjerg CM, Sverrild A, Lloyd CM, Menzies-Gow AN, et al · · 2020 · cited 113× · PMID 32586879 · DOI 10.1183/13993003.00260-2020
  3. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials.
    Kosloski MP, Kalliolias GD, Xu CR, Harel S, et al · · 2022 · cited 38× · PMID 34523807 · DOI 10.1111/cts.13157
  4. IL33 and Mast Cells-The Key Regulators of Immune Responses in Gastrointestinal Cancers?
    Eissmann MF, Buchert M, Ernst M. · · 2020 · cited 31× · PMID 32719677 · DOI 10.3389/fimmu.2020.01389
  5. Targeting the Epithelium-Derived Innate Cytokines: From Bench to Bedside.
    Ham J, Shin JW, Ko BC, Kim HY. · · 2022 · cited 21× · PMID 35291657 · DOI 10.4110/in.2022.22.e11
  6. Turning off the alarm - Targeting alarmins and other epithelial mediators of allergic inflammation with biologics.
    Albrecht M. · · 2021 · cited 11× · PMID 33615121 · DOI 10.5414/alx02194e
  7. Regulation of Airway Epithelial-Derived Alarmins in Asthma: Perspectives for Therapeutic Targets.
    Hansi RK, Ranjbar M, Whetstone CE, Gauvreau GM. · · 2024 · cited 7× · PMID 39457624 · DOI 10.3390/biomedicines12102312

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing