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Pulmonology CM-INS-033 // MARCH 2026

Asthma Clinical Trials 2026: Biologics for Severe Asthma & New Treatments

Medical Notice

This article is for informational purposes only and does not constitute medical advice. Clinical trial eligibility and availability vary. Always consult a qualified healthcare professional before making any medical decisions or considering participation in a clinical trial.

Summary

Asthma affects over 260 million people globally, and while most achieve good control with inhaled therapies, approximately 5–10% have severe asthma with frequent exacerbations despite maximum inhaler treatment. Biologic therapies targeting specific inflammatory pathways have transformed care for severe asthma. In 2026, trials are extending biologics to moderate asthma, exploring oral alternatives, and investigating whether biologic treatment can induce long-term remission.

Approved Biologics and What's Being Studied

Five biologics are approved for severe asthma: mepolizumab, benralizumab, reslizumab (anti-IL-5), dupilumab (anti-IL-4/13), and tezepelumab (anti-TSLP). Current trials are focused on:

  • Head-to-head comparisons: Which biologic is best for which patient — eosinophil count, FeNO, atopy, and other biomarkers guide selection in trials
  • Biologic discontinuation: Can patients in remission safely stop biologics? PONENTE and similar trials are addressing this
  • Moderate asthma trials: Extending biologics from severe to moderate uncontrolled asthma
  • Combination biologics: Dual pathway targeting for patients who fail single biologics

Itepekimab and Next-Generation Approaches

Itepekimab (anti-IL-33) showed particular benefit in ex-smokers with asthma — a population underserved by current biologics. Phase 3 trials are ongoing. Astegolimab (anti-IL-33 from Roche) has Phase 3 data showing exacerbation reduction across eosinophil levels — potentially useful for non-eosinophilic ("T2-low") asthma where current biologics are less effective.

Bronchial Thermoplasty and Device Trials

Bronchial thermoplasty (BT) is an FDA-approved bronchoscopic procedure using radiofrequency energy to reduce smooth muscle mass in the airways, decreasing bronchoconstriction. Long-term follow-up (10 years) shows sustained benefit. Second-generation BT devices with improved delivery systems are in Phase 2 trials. Metered cryospray and other ablative approaches are also being studied.

Who Qualifies for Asthma Trials

Biologic trials for severe asthma typically require: documented asthma diagnosis ≥12 months, current controller therapy (ICS/LABA ± LAMA ± OCS), ≥2 exacerbations in the past year or continuous oral corticosteroid use, and a specific inflammatory biomarker profile (eosinophil count, FeNO, total IgE). Most trials require stable asthma at screening (no exacerbation within 4 weeks) and exclusion of other diagnoses like EGPA or hypereosinophilic syndrome.

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