VE416 for Peanut Allergy

Overseen By Jannat Gill, BDS, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts General Hospital

Must not be taking: Beta blockers, ACE inhibitors, MAO inhibitors

Disqualifiers: Severe anaphylaxis, Severe asthma, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests VE416, a capsule with friendly bacteria, combined with an antibiotic and peanut flour, to help people with peanut allergies. The bacteria activate in the intestines and may help prevent allergic reactions. The goal is to see if this combination is safe and effective.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as beta blockers, angiotensin converting enzyme inhibitors, and monoamine oxidase inhibitors. Additionally, you should not have used systemic immunomodulatory treatments or biologics with an immune target in the past 6 months.

Research Team

Wayne G Shreffler, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people aged 12-55 with a confirmed peanut allergy, who can swallow capsules and are not pregnant or breastfeeding. They shouldn't have immune deficiencies, severe anaphylaxis history, poorly-controlled asthma, or be on certain heart medications or other immunomodulatory treatments.

Inclusion Criteria

People of any race, gender, or ethnicity between the ages of 12 and 55 who have a medical record showing they are allergic to peanuts.

Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE _5 kU/L at screening visit

Ara h 2 specific IgE >0.35 kU/L at screening visit

Exclusion Criteria

You are unable to swallow a small-sized pill.

You have a weakened immune system from birth.

You have used other treatments that affect your immune system within the past 6 months, including allergy shots or certain medications that target the immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive treatment to assess safety and treatment-related adverse events

7 weeks

Phase II Treatment

Participants receive VE416 in combination with vancomycin and peanut oral immunotherapy to evaluate the maximum tolerated dose of peanut protein

23 weeks

Post-Phase II Maintenance

Participants continue with maintenance treatment following Phase II

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

54 weeks

Treatment Details

Interventions

• VE416

Trial Overview The study tests VE416 as either a pretreatment or alongside low-dose peanut oral immunotherapy (PNOIT). Participants will be randomly assigned to one of four groups: some getting the real treatment plus PNOIT and others getting placebo versions.

Participant Groups

Group I: vancomycin plus VE416 before PNOIT Experimental Treatment 1 Intervention

active vancomycin plus VE416 before PNOIT

Group II: Vancomycin plus VE416 with PNOIT Experimental Treatment 1 Intervention

active vancomycin plus active VE416 with active PNOIT

Group III: Placebo plus VE416 with PNOIT Experimental Treatment 1 Intervention

placebo vancomycin plus active VE416 with active VE416

Group IV: Placebo plus placebo with PNOIT Active Control 1 Intervention

placebo vancomycin and placebo VE416 with active peanut oral immunotherapy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Vedanta Biosciences, Inc.

Industry Sponsor

Trials

7

Recruited

1,200+