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A phase 2 randomized controlled trial using biologics to improve multi OIT outcomes (COMBINE): design, rationale, and
A J Long1, S Sindher1, K Martinez1
1Department of Pathology, Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, CA, United States.
This study investigates combining biologics like omalizumab and dupilumab with multi-food oral immunotherapy (mOIT) to improve food allergy treatment. The goal is to enhance desensitization and reduce side effects for better patient outcomes.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Pharmacology
Background:
- Food allergy is a significant health issue impacting quality of life.
- Oral immunotherapy (OIT) shows efficacy but is limited by side effects.
- Biologics like omalizumab and dupilumab are being explored to improve OIT.
Purpose of the Study:
- To evaluate the safety and efficacy of omalizumab and/or dupilumab with multi-food oral immunotherapy (mOIT).
- To assess if combining biologics with mOIT improves desensitization and reduces adverse events.
- To test the hypothesis that dupilumab enhances omalizumab-facilitated mOIT for sustained unresponsiveness.
Main Methods:
- Phase 2, randomized, double-blind, placebo-controlled, multi-center study.
- Participants (4-55 years) with multi-food allergy (including peanut) randomized to three arms.
- Treatment involves mOIT combined with omalizumab and/or dupilumab or placebos.
- Efficacy assessed by double-blind placebo-controlled food challenges (DBPCFCs) at Week 32 and Week 44.
Main Results:
- N/A - Results not yet available in the abstract.
Conclusions:
- The trial aims to determine if combined biologic and mOIT therapy is superior to mOIT alone.
- Investigating the potential for increased sustained unresponsiveness and decreased adverse events.
- Evaluating the role of omalizumab and dupilumab in advancing food allergy immunotherapy.
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