40 Participants NeededMy employer runs this trial

MOON101 for Peanut Allergy

(SURVEYOR Trial)

Recruiting at 4 trial locations
SP
MC
Overseen ByMichelle C Widmann

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of a new treatment called MOON101 for individuals with peanut allergies. Researchers aim to determine if MOON101, which delivers tiny amounts of peanut allergen through the skin, causes any side effects and to identify the highest dose that can be tolerated without severe reactions. Participants will receive both MOON101 and a placebo (a treatment with no active ingredient) to compare effects. Individuals with a doctor-confirmed peanut allergy who react quickly after consuming peanuts might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. You cannot use β-blockers, ACE inhibitors, ARBs, or calcium channel blockers during the trial. You also need to temporarily stop antihistamines and topical steroids before specific tests.

Is there any evidence suggesting that MOON101 is likely to be safe for humans?

Research shows that MOON101 remains in the early stages of human safety testing. Detailed safety information from completed studies is not yet available. However, because the trial is in its first phase, researchers prioritize safety and closely monitor the treatment for any side effects. MOON101 is a small patch with tiny needles that introduces small amounts of peanut allergen into the skin, potentially reducing allergy sensitivity over time.

Participants in the trial will receive doses ranging from 1 microgram to 100 micrograms to determine the highest dose that does not cause significant symptoms. The trial focuses on how well participants tolerate these doses and records any treatment-related side effects. Although specific safety data from past studies is unavailable, this trial aims to identify potential side effects and their frequency to ensure future safety.12345

Why do researchers think this study treatment might be promising?

Unlike the current standard treatments for peanut allergies, which often include oral immunotherapy and avoidance strategies, MOON101 introduces a unique delivery method using microneedle stamps. This innovative approach allows for direct application of peanut protein to the skin, potentially reducing the risk of severe reactions seen with oral treatments. Researchers are excited because this method could offer a safer, more controlled way to desensitize individuals to peanuts, with the potential for varying dosages (1ug to 100ug) to cater to different sensitivity levels. This could lead to more personalized and less invasive treatment options for those with peanut allergies.

What evidence suggests that MOON101 might be an effective treatment for peanut allergy?

Research has shown that MOON101, a treatment for peanut allergies, has promising results in animal studies. It uses a tiny needle patch to deliver small amounts of peanut allergens directly into the skin. This method aims to reduce the allergic reaction to peanuts over time. Early studies have found MOON101 to be as effective as treatments like EpiPen in managing peanut allergies. Although researchers are still studying its effectiveness in people, these early results are encouraging. Participants in this trial will receive different doses of MOON101 to evaluate its effectiveness and safety.12678

Who Is on the Research Team?

SP

Samir Patel, PhD

Principal Investigator

Moonlight Therapeutics, Inc.

BP

Brian P Vickery, MD

Principal Investigator

Professor of Pediatrics, Emory University

Are You a Good Fit for This Trial?

This trial is for adults, teens, and children who have a peanut allergy. Participants must be able to safely take part in the study as determined by the researchers.

Inclusion Criteria

I am between 4 and 55 years old.
A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut
A peanut SPT with mean wheal diameter as defined by age
See 1 more

Exclusion Criteria

I have lab results showing liver or kidney disease.
I have used biologic or immunosuppressive therapies (not steroids) in the past 6 months.
Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive up to 5 escalating doses of MOON101 and placebo, with each dose administered every 7 days

5 weeks
5 visits (in-person), 5 follow-up phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up phone call and an in-clinic visit

2 weeks
1 visit (in-person), 1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

  • MOON101

Trial Overview

The study tests different single doses of MOON101 (which contains peanut allergen) compared to a placebo (no peanut allergen). Each participant receives both MOON101 and placebo at separate times to see which dose is safest.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose EExperimental Treatment1 Intervention
Group II: Dose DExperimental Treatment1 Intervention
Group III: Dose CExperimental Treatment1 Intervention
Group IV: Dose BExperimental Treatment1 Intervention
Group V: Dose AExperimental Treatment1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Moonlight Therapeutics, Inc.

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Citations

Moonlight Therapeutics Receives Clinical Trial Grant to ...

The approach has shown promising results in animal models of peanut and other allergies; data from these studies have been published in peer- ...

Moonlight's MOON-101 for peanut allergy gains IND approval

The treatment is designed for at-home self-administration and has shown promising results in preclinical studies of peanut allergy. In addition, ...

FDA Clears Moonlight Therapeutics to Begin Clinical Trial ...

MOON101 utilizes Moonlight's proprietary intradermal allergen immunotherapy platform to desensitize individuals with a food allergy. This ...

Safety of MOON101 for the Treatment of Peanut Allergy

This study is designed as an open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut ...

Scale-up manufacturing of microneedle stamp for peanut ...

It will set the stage to evaluate the efficacy of MOON101 to treat peanut allergy in a Phase 2 clinical trial and begin to address treatment of multiple food ...

Safety of MOON101 for the Treatment of Peanut Allergy

Safety of MOON101 for the Treatment of Peanut Allergy · Study identification · Conditions and interventions · Eligibility (public fields only).

FDA clears IND application for MOON101, a peanut allergy ...

MOON101 is an intradermal treatment for peanut allergy that utilizes a skin stamp. This significant milestone means that Moonlight Therapeutics ...

Moonlight Therapeutics Receives FDA Clearance of IND ...

Moonlight is developing MOON101 as a treatment for peanut allergy and has received clearance from the FDA to proceed clinical testing of ...