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Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 91 of 91 sites
    v44
  2. Study sites: 90 to 91v43
  3. Site details revised at 1 of 90 sitesv42
  4. Site details revised at 1 of 90 sitesv41
  5. Study sites: 89 to 90v40
Show 38 earlier versionsHide 38 earlier versions
  1. Site details revised at 1 of 89 sitesv39
  2. Site details revised at 1 of 89 sitesv38
  3. Site details revised at 1 of 89 sitesv37
  4. Site details revised at 1 of 89 sitesv36
  5. Site details revised at 4 of 89 sitesv35
  6. Site details revised at 1 of 89 sitesv34
  7. Site details revised at 1 of 89 sitesv33
  8. Site details revised at 2 of 89 sitesv32
  9. Site details revised at 2 of 89 sitesv31
  10. Study sites revised (89)v30
  11. Site details revised at 3 of 89 sitesv29
  12. Site details revised at 2 of 89 sitesv28
  13. Site details revised at 3 of 89 sitesv27
  14. Site details revised at 3 of 89 sitesv26
  15. Site details revised at 6 of 89 sitesv25
  16. Site details revised at 3 of 89 sitesv24
  17. Site details revised at 3 of 89 sitesv23
  18. Site details revised at 1 of 89 sitesv22
  19. Site details revised at 5 of 89 sitesv21
  20. Study sites revised (89)v20
  21. Site details revised at 2 of 89 sitesv19
  22. Site details revised at 4 of 89 sitesv18
  23. Site details revised at 4 of 89 sitesv17
  24. Study sites: 72 to 89v16
  25. Study sites: 60 to 72v15
  26. Study sites: 58 to 60v14
  27. Site details revised at 1 of 58 sitesv13
  28. Site details revised at 1 of 58 sitesv12
  29. Site details revised at 1 of 58 sitesv11
  30. Site details revised at 2 of 58 sitesv10
  31. Site details revised at 3 of 58 sitesv9
  32. Site details revised at 1 of 58 sitesv8
  33. Study sites: 56 to 58v7
  34. Site details revised at 1 of 56 sitesv6
  35. Study sites revised (56)v5
  36. Study sites: 1 to 56v4
  37. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2025 to Jun 24, 2025
    v3
  38. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
Trial Details
NCT Number NCT07003919
Lead Sponsor DBV Technologies
Conditions
(from sponsor)		 Allergy, Peanut Allergy
Related terms Food Hypersensitivity, Hypersensitivity, Nut and Peanut Hypersensitivity, Peanut Hypersensitivity
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov