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Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure

Study acronym: PREDICT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Dec 2025 → Dec 2028
See other at-risk trials from Medical University of Graz

Record History

  1. Primary completion pushed from Dec 2025 to Dec 2028 Completion pushed from Mar 2026 to Mar 2029 · Eligibility criteria expanded, about 2 words Show 2 more changesShow less
    • Completion pushed from Mar 2026 to Mar 2029
    • Eligibility criteria expanded, about 2 words
  2. Study sites: 1 to 3v8
  3. 2 versions Re-verified since Mar 12, 2024, no change to tracked fieldsv6-v7
  4. Primary completion date: Dec 2022 to Dec 2025 Completion date: Mar 2023 to Mar 2026v5 Show 1 more changeShow less
    • Completion date: Mar 2023 to Mar 2026
  5. 3 versions Re-verified since Feb 7, 2020, no change to tracked fieldsv2-v4
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Venom immunotherapy (VIT) is an established treatment for Hymenoptera venom allergy and provides long-term protection from further generalized reactions in almost all patients. However, it is still unclear why bee VIT is less effective than vespid VIT. The preliminary data show that not only predominant Api m 10 sensitization but also other predominant sensitizations may be relevant as risk factors for treatment failure. Interestingly, all patients with a predominant Api m 10 sensitization who received bee VIT with a venom preparation with a supposed lack of Api m 10 tolerated sting challenges. Therefore, a multicenter study with a sufficient number of patients with treatment failure is urgently required, to clarify if predominant sensitization to a bee venom allergen is a risk factor for treatment failure. If predominant sensitization is a risk factor and caused by underrepresented components in bee venom preparations used for VIT, bee venom preparations may be optimized in the future and patients would benefit from a more effective VIT.
Trial Details
NCT Number NCT04259359
Lead Sponsor Medical University of Graz
Conditions Bee Venom Allergy
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov