VITESSE Phase 3: VIASKIN® Peanut patch 250 µg in peanut-allergic children aged 4–7 years
Trial setup
- Study: VITESSE (NCT05741476), Phase 3, randomized, double-blind, placebo-controlled. - Population: children age 4–7 years with peanut allergy. - Randomization: 2:1 active (VIASKIN Peanut patch 250 µg) vs placebo. - Duration: 12-month double-blind treatment period, then optional open-label extension. - Primary endpoint: difference in % of treatment responders at Month 12 (active minus placebo). - Responder definition (DBPCFC eliciting dose, ED): - baseline ED ≤ 30 mg and Month-12 ED ≥ 300 mg, OR - baseline ED = 100 mg and Month-12 ED ≥ 600 mg.
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Resolution
DBV Technologies reported that the pivotal Phase 3 VITESSE trial in peanut-allergic children aged 4–7 years met its primary endpoint at 12 months: responder rates were 46.6% on VIASKIN® Peanut patch vs 14.8% on placebo (difference 31.8%; 95% CI 24.5% to 39.0%), exceeding the prespecified 15% lower-bound threshold. Safety was described as consistent with prior VIASKIN Peanut experience, with discontinuations due to TEAEs of 3.2% (active) vs 0.5% (placebo). The press release reported no treatment-related serious adverse events and treatment-related anaphylaxis of 0.5% (n=2), with both children continuing treatment. Overall compliance was reported as 96.2%.