Peanut SLIT-Tablet for Peanut Allergy

Recruiting at27 trial locations

Overseen by Edwin Kim, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: ALK-Abelló A/S

Must not be taking: Systemic corticosteroids

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the Peanut SLIT-tablet treatment for peanut allergy?

Research shows that sublingual immunotherapy (SLIT) tablets can help improve allergic conditions like rhinitis and asthma, and studies specifically on peanut SLIT have shown modest desensitization in children with peanut allergies over a year. Extended treatment may offer additional benefits. ^{1 2 3 4 5}

Is the Peanut SLIT-Tablet safe for humans?

The Peanut SLIT-Tablet has shown a favorable safety profile in clinical trials, with fewer and less severe side effects compared to other treatments. It is generally well-tolerated, though it may cause local reactions or, rarely, systemic allergic reactions. ^{1 2 5 6 7}

How is the Peanut SLIT-tablet treatment different from other treatments for peanut allergy?

The Peanut SLIT-tablet is unique because it is a sublingual immunotherapy, meaning it is placed under the tongue to help the body become less sensitive to peanuts. This method is generally well-tolerated and has fewer and less severe side effects compared to other treatments, like oral immunotherapy, making it a safer option for many patients. ^{1 2 4 5 6}

Research Team

Edwin Kim, MD

Principal Investigator

University of North Carolina

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Peanut SLIT-tablet (Immunotherapy)

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.

Participant Groups

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+

Costa Panagos

Syneos Health

Chief Executive Officer

Bachelor's degree in a relevant field (specific details not available)

Suma Ramadas

Syneos Health

Chief Medical Officer since 2022

PhD in a relevant field (specific details not available)

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term sublingual immunotherapy for peanut allergy in children: Clinical and immunologic evidence of desensitization. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Allergen Release Profiles of Fast-Dissolving Freeze-Dried Orodispersible Sublingual Allergy Immunotherapy Tablets. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Sublingual immunotherapy for food allergy and its future directions. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sublingual allergen immunotherapy. [2022]