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Investigating Dupilumab's Effect in Asthma by Genotype

Study acronym: IDEA
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 2026 to Jan 2027
    • Site details revised at 6 of 6 sites
    v27
  2. Re-verified, no change to tracked fieldsv26
  3. Site contacts updated at 2 of 6 sitesv25
  4. Study sites: 7 to 6v24
  5. 2 versions Re-verified since Nov 22, 2024, no change to tracked fieldsv22-v23
Show 20 earlier versionsHide 20 earlier versions
  1. Site contacts updated at 1 of 7 sitesv21
  2. Site contacts updated at 1 of 7 sitesv20
  3. Site contacts updated at 2 of 7 sitesv19
  4. Primary completion date: Sep 2023 to Sep 2026
    • Study completion date: Mar 2024 to Mar 2027
    v18
  5. Site details revised at 1 of 7 sitesv17
  6. Site details revised at 2 of 7 sitesv16
  7. Site details revised at 2 of 7 sitesv15
  8. Study sites: 4 to 7
    • Collaborators revised (5)
    v14
  9. Collaborators: 1 to 5v13
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Sep 8, 2021
    • Site details revised at 4 of 4 sites
    v12
  11. Start date: Jul 2021 to Sep 2021
    • Primary completion date: Aug 2023 to Sep 2023
    • Study completion date: Feb 2024 to Mar 2024
    • Site contacts updated at 1 of 4 sites
    v11
  12. Secondary endpoints: details revised at 2 of 2 entriesv10
  13. Enrollment target: 126 to 150v9 Show 9 more changesShow less
    • Study sites: 1 to 4
    • Primary completion date: Oct 2023 to Aug 2023
    • Study completion date: Oct 2023 to Feb 2024
    • Start date: Jun 2021 to Jul 2021
    • Eligibility criteria shortened, about 264 words
    • Secondary endpoints: 1 to 2
    • Study description revised
    • Collaborators expanded, about 8 words
    • Study title shortened, about 7 words
  14. Start date: Jun 2020 to Jun 2021v8
  15. Start date: Oct 2019 to Jun 2020v7
  16. Eligibility criteria expanded, about 216 wordsv6
  17. Phase: Phase 2 to Phase 4v5
  18. Eligibility criteria expanded, about 20 words
    • Study title expanded, about 2 words
    v4
  19. Primary endpoint revisedv3
  20. Interventions: Dupilumab (Drug) to Dupilumab (Drug), Placebo (Other)
    • Eligibility criteria shortened, about 20 words
    • Study description shortened, about 11 words
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.
Trial Details
NCT Number NCT03694158
Lead Sponsor Boston Children's Hospital
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Regeneron Pharmaceuticals, HealthBeacon Plc, Merck Sharp & Dohme LLC, Sanofi
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov