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Allergy Immunotherapy

Active treatment for Peanut Allergy

Phase 1

Waitlist Available

Research Sponsored by Intrommune Therapeutics

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up forty-eight weeks

Awards & highlights

Study Summary

This trial is testing a new peanut allergy treatment to see if it is safe and effective. People with peanut allergies will be given either the treatment or a placebo, and the effects will be monitored.

Eligible Conditions

Peanut Allergy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ forty-eight weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~forty-eight weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and forty-eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.

Secondary outcome measures

To determine the maximally tolerated dose during the up-dosing phase for adults.

To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.

Other outcome measures

Therapeutic procedure

To explore changes in peanut-specific IgG4, IgA, and IgE levels in participants (exploratory outcome).

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active treatmentActive Control1 Intervention

INT301 dosing as determined by cohort assignment

Group II: PlaceboPlacebo Group1 Intervention

Placebo as determined by cohort assignment

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Intrommune TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Active treatment obtained regulatory approval from the FDA?

"Active treatment currently receives a score of 1, as safety has only been evaluated in one phase and efficacy is yet to be established."

Answered by AI

May I partake in this experiment?

"This clinical trial necessitates 32 volunteers between the ages of eighteen and fifty-five who are confirmed to have a peanut allergy. To be eligible, they must also sign an informed consent form that includes compliance with related restrictions and protocols, present negative serum beta HCG pregnancy test results (for female participants), pass SPT or IgE tests, prove their history of allergic reactions to peanuts over the previous three months by failing OFC tests containing less than 100mgs of peanut protein, as well as agree to participate actively in all assessments required throughout this study."

Answered by AI

Is the elderly population being included in this investigation?

"The eligibility criteria for this clinical trial stipulate that participants must be between 18-55 years old."

Answered by AI

Is this experiment open to recruitment at the moment?

"According to clinicaltrials.gov, this medical trial is not presently accepting patients for participation. Initially posted on May 15th 2021 and last updated October 14th 2022, the study has yet to begin recruitment efforts despite there being 259 other active trials looking for volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

2021. "OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04603300.