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Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Study acronym: VITESSE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Nov 2025 to Nov 6, 2025
    • Site details revised at 16 of 87 sites
    v17
  2. Study sites: 86 to 87v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 2026 to Nov 2025
    • Study completion date: May 2029 to Oct 2029
    • Site details revised at 86 of 86 sites
    v15
  4. Primary completion date: Mar 2025 to Sep 2026v14 Show 9 more changesShow less
    • Primary endpoint revised
    • Study sites: 87 to 86
    • Study completion date: Mar 2025 to May 2029
    • Start date: Mar 22, 2023 to Feb 21, 2023
    • Interventions: DBV712 (Drug), Placebo (Other) to DBV712 (Drug), DBV712 (Drug), Placebo (Other)
    • Eligibility criteria expanded, about 180 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 61 words
    • Study arms: 2 to 3
  5. Site details revised at 8 of 87 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 58 to 87v12
  2. Study sites: 61 to 58v11
  3. Site details revised at 5 of 61 sitesv10
  4. Study sites: 60 to 61v9
  5. Site details revised at 6 of 60 sitesv8
  6. Study sites: 57 to 60v7
  7. Study sites: 56 to 57v6
  8. Study sites: 54 to 56v5
  9. Start date changed from estimate of Mar 15, 2023 to Mar 22, 2023
    • Site details revised at 5 of 54 sites
    v4
  10. Site details revised at 1 of 54 sitesv3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 54
    • Start date: Feb 2023 to Mar 15, 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
Trial Details
NCT Number NCT05741476
Lead Sponsor DBV Technologies
Conditions
(from sponsor)		 Allergy, Peanut
Related terms Food Hypersensitivity, Nut and Peanut Hypersensitivity, Peanut Hypersensitivity
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov