Peanut SLIT-Tablet for Peanut Allergy

Recruiting at 41 trial locations

Overseen By Clinical Project Manager

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ALK-Abelló A/S

Must not be taking: Systemic corticosteroids

Disqualifiers: Eosinophilic esophagitis, Uncontrolled asthma, Cardiovascular disease, others

Compensation: Varies

Number of Visits: 1

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing peanut allergies using a daily peanut SLIT-tablet, which dissolves under the tongue. The goal is to assess the safety and effectiveness of this treatment for individuals with a history of allergic reactions to peanuts. The trial includes various groups—adults, adolescents, and children—and examines their responses to the treatment over time. It may suit those who have documented peanut allergies and continue to experience symptoms despite avoiding peanuts. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking allergy management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications listed by the trial. If you are on allergy immunotherapy, you must not be in the up-dosing phase, but maintenance doses of non-peanut immunotherapy are allowed.

Is there any evidence suggesting that the peanut SLIT-tablet is likely to be safe for humans?

Research has shown that the peanut SLIT-tablet is generally safe for people with peanut allergies. In earlier studies, less than 5% of doses caused side effects, which were mostly mild, such as a brief itch in the mouth. Another study found that at different dose levels, the side effects were mostly mild and short-lived. This suggests that most people can tolerate the peanut SLIT-tablet well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peanut allergy?

Unlike traditional treatments for peanut allergies, which often involve strict avoidance, emergency epinephrine, or injectable immunotherapy, the peanut SLIT-tablet offers a novel approach. This treatment uses sublingual immunotherapy, where a small tablet is placed under the tongue, potentially making it easier and less invasive for patients. Researchers are excited because this method could desensitize the immune system to peanuts, reducing allergic reactions over time. Additionally, the tablet format is convenient and may improve adherence compared to injections.

What evidence suggests that the Peanut SLIT-tablet might be an effective treatment for peanut allergy?

Research shows that the peanut SLIT-tablet, which participants in this trial will receive, can help people with peanut allergies become less sensitive to peanuts. Studies have found that this treatment reduces allergic reactions and increases tolerance over time. Specifically, children treated for 48 months showed clear improvement in handling more peanuts without reacting. The treatment is considered safe, with most side effects being mild and short-lasting. Overall, this method offers a promising way to reduce peanut allergy symptoms in both children and adults. ^{1 2 5 6 7}

Who Is on the Research Team?

Edwin Kim, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 4 and 65 years old.

Peanut-specific serum IgE ≥ 0.7 kUA/L at screening measured at central laboratory

I had severe reactions to peanut protein during a test.

Exclusion Criteria

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

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

I am not increasing my dose of any allergy shots, except for peanut allergy treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person)

Part 1: Dose Determination

Subjects receive a peanut SLIT-tablet with one of five doses once daily for 2 weeks to determine the entry dose for the up-dosing regimen

2 weeks

Part 2: Up-dosing Regimen

Subjects receive a series of increasing doses of the peanut SLIT-tablet, each taken once daily for 2 weeks, to characterize tolerability

10 weeks

Part 3: Maintenance Treatment

Subjects receive maintenance doses of the peanut SLIT-tablet once daily for 24 weeks, or corresponding placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peanut SLIT-tablet

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 3: Maintenance B Experimental Treatment 1 Intervention

UDR B + maintenance dose B

Group II: Part 3: Maintenance A Experimental Treatment 1 Intervention

UDR A + maintenance dose A

Group III: Part 2: Cohort 9 Experimental Treatment 1 Intervention

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

Group IV: Part 2: Cohort 8 Experimental Treatment 1 Intervention

Children - UDR with once daily peanut SLIT-tablet

Group V: Part 2: Cohort 7 Experimental Treatment 1 Intervention

Adolescents - UDR with once daily peanut SLIT-tablet

Group VI: Part 2: Cohort 6 Experimental Treatment 1 Intervention

Adults - UDR with once daily peanut SLIT-tablet

Group VII: Part 2: Cohort 10 Experimental Treatment 1 Intervention

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

Group VIII: Part 1: Cohort 5 Experimental Treatment 1 Intervention

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Group IX: Part 1: Cohort 4 Experimental Treatment 1 Intervention

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Group X: Part 1: Cohort 3 Experimental Treatment 1 Intervention

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Group XI: Part 1: Cohort 2 Experimental Treatment 1 Intervention

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Group XII: Part 1: Cohort 1 Experimental Treatment 1 Intervention

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Group XIII: Part 3: Placebo Placebo Group 1 Intervention

Placebo UDR + placebo maintenance

Who Is Running the Clinical Trial?

ALK-Abelló A/S

Lead Sponsor

Trials

77

Recruited

328,000+

Peter Halling

ALK-Abelló A/S

Chief Executive Officer since 2024

M.Sc. from Copenhagen Business School

Bertil Lindmark

ALK-Abelló A/S

Chief Medical Officer since 2022

MD

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Published Research Related to This Trial

Sublingual immunotherapy (SLIT)-tablets have demonstrated consistent clinical efficacy for treating allergic rhinoconjunctivitis (ARC) in large, double-blind, placebo-controlled trials, benefiting both monosensitized and polysensitized patients.

SLIT-tablets are generally safer than subcutaneous immunotherapy, with no new safety concerns reported after treatment interruptions, making them a promising option for managing allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sublingual allergen immunotherapy. DuBuske, L.[2022]

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]

The freeze-dried sublingual allergy immunotherapy tablets (SLIT-tablets) rapidly disintegrate and release major allergens within 1 second, ensuring effective allergen exposure for the immune system.

The study demonstrated that the tree SLIT-tablet achieved full T-cell activation at just 30 seconds, indicating that these tablets are designed for quick and efficient allergen delivery, which is crucial for effective allergy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergen Release Profiles of Fast-Dissolving Freeze-Dried Orodispersible Sublingual Allergy Immunotherapy Tablets. Yamamoto, T., Ohashi-Doi, K., Matsuhara, H., et al.[2022]

In a study of 21 children aged 7 to 13 with peanut allergy, oral immunotherapy (OIT) was found to be significantly more effective than sublingual immunotherapy (SLIT), with a greater than 10-fold increase in challenge threshold after 12 months, particularly in the OIT group (141-fold vs. 22-fold).

While OIT showed superior efficacy, it was also associated with more adverse reactions, including moderate reactions that required medication, indicating a trade-off between effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy. Narisety, SD., Frischmeyer-Guerrerio, PA., Keet, CA., et al.[2018]

Sublingual immunotherapy (SLIT) tablets for treating allergies are generally well tolerated, with no reports of life-threatening events or serious systemic allergic reactions in pooled analyses of multiple clinical trials involving timothy grass, short ragweed, and house dust mite.

The most common side effects are mild oral site reactions that typically start on the first day of treatment, last less than two weeks, and resolve quickly, indicating that while some reactions can occur, they are manageable and not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice. Bernstein, DI., Bardelas, JA., Svanholm Fogh, B., et al.[2017]

Extended peanut sublingual immunotherapy (SLIT) for up to 5 years resulted in significant desensitization in children with peanut allergies, with 67% of participants able to consume 750 mg or more of peanut protein without symptoms during food challenges.

The treatment demonstrated a favorable safety profile, with only 4.8% of doses causing side effects, primarily mild oropharyngeal itching, and no serious reactions requiring epinephrine, indicating that long-term SLIT is both effective and safe for managing peanut allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization. Kim, EH., Yang, L., Ye, P., et al.[2020]

Sublingual immunotherapy (SLIT) for food allergies, particularly peanut allergy, has shown promising results in Phase II studies, significantly increasing the tolerated dose of peanuts with fewer and less severe side effects compared to other treatment methods.

SLIT involves daily placement of glycerinated allergen under the tongue to achieve desensitization, and ongoing research is exploring its mechanisms and potential for broader applications in oral mucosal immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual immunotherapy for food allergy and its future directions. Schworer, SA., Kim, EH.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4527157/

Sublingual immunotherapy for peanut allergy: Long-term ... Peanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile.

2. ir.alk.net ir.alk.net/news-releases/news-release-details/positive-results-advance-peanut-tablet-phase-ii-development

Positive results advance peanut tablet to phase II ... For all dose levels, the tablet was shown to be safe and tolerable. The vast majority of treatment-emergent side effects were transient, mild to ...

3. trials.foodallergy.org trials.foodallergy.org/trials/NCT05440643

Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment ... This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy ...

4. jacionline.org jacionline.org/article/S0091-6749(23)00218-X/fulltext

Open-label study of the efficacy, safety, and durability ... In our study of peanut SLIT in 1- to 11-year-old children treated for 48 months, we showed improved desensitization with peanut SLIT compared ...

5. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(24)00198-3/fulltext

Safety and Effectiveness of Bypassing Oral Immunotherapy ... Open-label study of the efficacy, safety, and durability of peanut sublingual immunotherapy in peanut-allergic children. J Allergy Clin Immunol.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10257751/

Open-label study of the efficacy, safety and durability ... Peanut SLIT appears safe with <5% of doses causing side effects and most being transient mouth itch. Introduction: Food allergy continues to be ...

7. trialx.com trialx.com/clinical-trials/listings/282789/peanut-sublingual-immunotherapy-slit-tablet-for-treatment-of-peanut-allergy/?&geo_lat=27.9961&geo_lng=-82.582&radius=10&place=Tampa&user_country=United%20States

Peanut Sublingual Immunotherapy (SLIT)-Tablet for ... Overview. This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet.