Allergic Rhinitis Immunotherapy DF19001: Phase 2b/3 IND Submission for 336 Patients
Phase 2b/3 IND submission for allergic rhinitis immunotherapy DF19001, targeting 336 patients (3 arms, 112 per arm)
52-week, multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety in house dust mite allergic rhinitis patients
Primary endpoint: average daily combined symptom-medication score for rhinitis; IDMC will perform interim analysis after 2b phase to recalculate Phase 3 sample size
Conducted at Severance Hospital, expected duration ~52 months from IRB approval; additional disclosure upon IND approval
KOSDAQ Filing Information
Filing: Major Management Matters Related to Investment Decision(Clinical Trial Plan Approval Application) (Application for Approval of Clinical Trial Plan (IND) for Allergy Rhinitis Immunotherapy DF19001 Phase 2b/3)