What is the mechanism of action of this treatment?

The most common treatments for peanut allergy, such as sublingual immunotherapy (SLIT) and oral immunotherapy (OIT), work by gradually exposing the patient to small, controlled amounts of the peanut allergen. This exposure helps the immune system build tolerance, reducing the severity of allergic reactions over time. SLIT involves placing a tablet containing the allergen under the tongue, while OIT involves ingesting the allergen orally. These treatments are significant for peanut allergy patients as they can potentially lower the risk of life-threatening anaphylactic reactions and improve the quality of life by allowing for more dietary freedom.

What side effects are associated with this type of intervention?

Sublingual immunotherapy (SLIT) for peanut allergy commonly causes local side effects such as itching or swelling in the mouth and throat. Systemic reactions, though less frequent, can include gastrointestinal symptoms, respiratory issues, and, in rare cases, anaphylaxis. Compliance may be challenging due to these side effects, but close follow-up can help manage them.

What prior FDA approvals exist?

The FDA has approved treatments for peanut allergy that focus on building tolerance to the allergen. One notable approval is for Palforzia, an oral immunotherapy (OIT) that helps mitigate allergic reactions by gradually increasing exposure to peanut protein. While specific FDA approvals for sublingual immunotherapy (SLIT) for peanut allergy are not detailed, SLIT has been studied for its potential to build tolerance to allergens, including peanuts, by placing small doses of the allergen under the tongue. These treatments aim to reduce the severity of allergic reactions over time.

What other types of research exist?

Promising alternatives to Peanut SLIT-tablet for peanut allergy patients include Oral Immunotherapy (OIT) and Epicutaneous Immunotherapy (EPIT). OIT has shown significant desensitization rates, especially in young children, though it has a higher rate of adverse events. EPIT, which involves applying a peanut protein patch to the skin, is another emerging option with ongoing clinical trials indicating potential efficacy and a favorable safety profile.

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Immunotherapy

Peanut SLIT-Tablet for Peanut Allergy

Phase 1 & 2

Recruiting

Led By Edward Kim, MS

Research Sponsored by ALK-Abelló A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged 4 through 65 years (inclusive) on the day of enrollment for Part 2

Male or female aged 12 through 65 years (inclusive) on the day of enrollment for Part 1

Must not have

Diagnosis or history of eosinophilic esophagitis

All subjects ≥ 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.

Summary

This trial tests a tablet containing small amounts of peanut protein taken under the tongue. It aims to help people with peanut allergies become less sensitive to peanuts. Participants will take gradually increasing doses to see if their tolerance improves.

Who is the study for?

This trial is for individuals aged 4-65 with a documented history of allergic reactions to peanuts, confirmed by specific tests. They must have had symptoms at certain doses during a controlled food challenge. People with uncontrolled asthma, recent peanut immunotherapy, or severe respiratory issues can't participate.

What is being tested?

The study is examining the safety and how well people tolerate a peanut SLIT-tablet as a treatment for peanut allergies. Participants will receive this tablet under their tongue to see if it helps reduce their allergy symptoms.

What are the potential side effects?

Potential side effects may include itching in the mouth, throat irritation, nausea, stomach pain or discomfort after taking the SLIT-tablet. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 65 years old.

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I am between 12 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with or have a history of eosinophilic esophagitis.

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I am 5 or older with lung function less than 70% of what's expected.

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I am 4 years old or older and have needed asthma medication for the past 3 months.

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I have asthma with a control score of 19 or below.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 and 2: Dose tolerability response rate

Part 3: TD-600 response rate

Secondary study objectives

Part 1, 2 and 3: Treatment-emergent adverse events

Part 3: Maximum severity of symptoms at each challenge dose of peanut protein during DBPCFC

Part 3: Maximum tolerated dose of peanut protein during DBPCFC

+4 more

Trial Design

13Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3: Maintenance BExperimental Treatment1 Intervention

UDR B + maintenance dose B

Group II: Part 3: Maintenance AExperimental Treatment1 Intervention

UDR A + maintenance dose A

Group III: Part 2: Cohort 9Experimental Treatment1 Intervention

Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet

Group IV: Part 2: Cohort 8Experimental Treatment1 Intervention

Children - UDR with once daily peanut SLIT-tablet

Group V: Part 2: Cohort 7Experimental Treatment1 Intervention

Adolescents - UDR with once daily peanut SLIT-tablet

Group VI: Part 2: Cohort 6Experimental Treatment1 Intervention

Adults - UDR with once daily peanut SLIT-tablet

Group VII: Part 2: Cohort 10Experimental Treatment1 Intervention

Highly sensitized Children - UDR with once daily peanut SLIT-tablet

Group VIII: Part 1: Cohort 5Experimental Treatment1 Intervention