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Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

108 Participants Needed

Biologics for Food Allergies

Recruiting at 3 trial locations

Overseen BySNP Center Inquiry

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Immunomodulators, Beta-blockers, ACE inhibitors, others

Disqualifiers: Cardiovascular disease, Severe anaphylaxis, Severe asthma, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as immunomodulator therapy (except corticosteroids), beta-blockers, ACE inhibitors, ARBs, and calcium channel blockers. If you are on these medications, you may need to discuss alternatives with your doctor before participating.

What data supports the effectiveness of the drug Dupilumab (Dupixent) or Omalizumab for treating food allergies?

The research mentions that Omalizumab, an anti-IgE antibody, does not increase serum IgE levels, which suggests it might help manage allergic reactions. Additionally, other studies on food-specific immunotherapy show effectiveness in desensitizing allergies, indicating potential for similar treatments.¹ ² ³ ⁴ ⁵

Is the treatment generally safe for humans?

Biologics like omalizumab have been used to improve the safety of food allergy treatments by reducing allergic reactions. However, food allergy immunotherapies can still cause allergic side effects, including serious reactions like anaphylaxis (a severe allergic reaction).³ ⁶ ⁷ ⁸ ⁹

How does the placebo treatment differ from other treatments for food allergies?

The placebo treatment, also known as a dummy treatment, is used as a control in clinical trials to compare the effects of new treatments, like biologics, which target the immune system to prevent allergic reactions. Unlike biologics, the placebo does not contain active ingredients and does not provide therapeutic effects, serving instead to help researchers understand the true efficacy of the tested treatment.⁵ ¹⁰ ¹¹ ¹² ¹³

What is the purpose of this trial?

This trial tests omalizumab and dupilumab with oral immunotherapy in people aged 4 to 55 who have multiple food allergies, including peanut. The treatments aim to reduce allergic reactions and help the body build tolerance to allergens. Omalizumab has shown potential in speeding up the process and making it safer.

Research Team

Rebecca S Chinthrajah, M.D.

Principal Investigator

Sean N Parker Center for Allergy and Asthma Center at Stanford

Eligibility Criteria

The COMBINE study is for people aged 4-55 with multiple food allergies, including peanut. Participants must have a confirmed allergy through specific tests and react to small amounts of allergens in a controlled challenge. They should not be severely asthmatic, pregnant, or on certain heart or immune-modifying medications.

Inclusion Criteria

You have a history of being allergic to peanuts and one or two other foods from a list that includes milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. If you cannot eat both cooked and uncooked forms of milk and egg, it is considered an allergy.

Positive allergy test determined by: ImmunoCAP serum IgE level >4 kUA/L for each allergen within the past 12 months OR Skin prick test (SPT) ≥6 mm wheal diameter to each allergen

Subject and/or parent guardian must be able to understand and provide informed consent

See 7 more

Exclusion Criteria

I am currently receiving immunotherapy for allergies or venom.

Pregnancy or lactation

I have had issues like severe acid reflux, trouble swallowing, or unexplained stomach problems.

See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omalizumab or placebo for 8 weeks, followed by 24 weeks of treatment with either placebo or dupilumab, along with multifood allergen oral immunotherapy

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

Dupilumab
Omalizumab
Placebo

Trial Overview This trial is testing the effectiveness of Omalizumab and Dupilumab—two biologic drugs—in improving outcomes for patients undergoing oral immunotherapy (OIT) for multiple food allergies compared to a placebo group.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort C: DupilumabExperimental Treatment2 Interventions

Participants will be treated with placebo for 8 weeks, followed by 24 weeks of treatment with dupilumab.

Group II: Cohort B: Omalizumab/DupilumabExperimental Treatment2 Interventions

Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.

Group III: Cohort A: OmalizumabExperimental Treatment2 Interventions

Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Food Allergy Research & Education

Collaborator

Trials

Recruited

31,100+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

Peanut sublingual immunotherapy (SLIT) demonstrated a favorable long-term safety profile, with 98% of doses tolerated without severe reactions, and no use of epinephrine required during the study.

After 3 years of treatment, only 10.8% of participants achieved full desensitization to peanuts, indicating modest efficacy, while over 50% of subjects discontinued therapy before the study's conclusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.Burks, AW., Wood, RA., Jones, SM., et al.[2022]

Oral immunotherapy (OIT) for food allergies carries a risk of adverse reactions, including anaphylaxis, which is a significant barrier to its clinical use.

There is a need for an international consensus on safety reporting in OIT studies to better understand its safety profile and develop safer, individualized treatment pathways for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn.Vázquez-Cortés, S., Jaqueti, P., Arasi, S., et al.[2020]

References

1.United Statespubmed.ncbi.nlm.nih.gov

Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial. [2022]

2.Denmarkpubmed.ncbi.nlm.nih.gov

Randomized immunotherapy trial in dual-allergic patients using "active allergen placebo" as control. [2021]

3.United Statespubmed.ncbi.nlm.nih.gov

Objective approach for fending off the sublingual immunotherapy placebo effect in subjects with pollenosis: double-blinded, placebo-controlled trial. [2015]

4.Denmarkpubmed.ncbi.nlm.nih.gov

Intranasal administration of allergen increases specific IgE whereas intranasal omalizumab does not increase serum IgE levels-A pilot study. [2021]

5.United Statespubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. [2022]

6.United Statespubmed.ncbi.nlm.nih.gov

Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn. [2020]

7.United Statespubmed.ncbi.nlm.nih.gov

Enhancing the Safety and Efficacy of Food Allergy Immunotherapy: a Review of Adjunctive Therapies. [2018]

8.United Statespubmed.ncbi.nlm.nih.gov

Novel Therapies for Treatment of Food Allergy. [2020]

9.Germanypubmed.ncbi.nlm.nih.gov

[Immunotherapy of allergies: current status]. [2020]