Protocol for a multinational, investigator-initiated, parallel group, randomised, double-blind, placebo-controlled phase 3b superiority trial assessing the effect of dupilumab on inducing clinical remission outcomes in at-risk type-2 inflammatory asthma (HOTHOT)

Key Points

• Assess the effect of dupilumab on inducing clinical remission in at-risk individuals with type-2 inflammatory asthma.
• Multinational, investigator-initiated design
• Parallel group randomised trial
• Double-blind and placebo-controlled setup
• Adheres to SPIRIT 2025 guidelines
• Results will be reported at international meetings
• Findings will be published in peer-reviewed journals