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Immunotherapy

Long-term AR101 for Peanut Allergy

Phase 3

Waitlist Available

Research Sponsored by Aimmune Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following 3-5 years of ar101 treatment

Awards & highlights

Study Summary

This trial will test a new allergy drug to see if it is safe and effective when taken for a long period of time.

Eligible Conditions

Peanut Allergy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following 3-5 years of ar101 treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following 3-5 years of ar101 treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and following 3-5 years of ar101 treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events including serious adverse events (Safety and Tolerability)

Secondary outcome measures

Peanut allergy desensitization through extended maintenance dosing of AR101

Side effects data

From 2018 Phase 3 trial • 506 Patients • NCT03126227

53%

Abdominal pain

46%

Throat irritation

41%

Abdominal discomfort

39%

Vomiting

37%

Pruritus

34%

Nausea

33%

Cough

27%

Headache

26%

Urticaria

24%

Nasal congestion

22%

Abdominal pain upper

22%

Upper respiratory tract infection

20%

Sneezing

19%

Rhinorrhoea

19%

Pyrexia

15%

Oral pruritus

15%

Oropharyngeal pain

14%

Paraesthesia oral

13%

Diarrhoea

12%

Wheezing

12%

Rash

11%

Nasopharyngitis

11%

Anaphylactic reaction

11%

Lip pruritus

10%

Tongue pruritus

10%

Throat tightness

Influenza

Dyspepsia

Flushing

Eye pruritus

Erythema

Viral infection

Dyspnoea

Lip swelling

Pharyngitis streptococcal

Ear pruritus

Asthma

Chest discomfort

Gastroenteritis viral

Rhinitis allergic

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Powder

AR101 Powder Provided in Capsules

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment Pathway 1, 2, 3, 4, 5Experimental Treatment1 Intervention

Subjects will be assigned to one of five treatment pathways when first enrolled into ARC008, which is dependent on the treatment received (AR101 or placebo) during the parent study and their tolerance of this treatment regimen (e.g., daily or non-daily schedule).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AR101

2017

Completed Phase 3

~2200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aimmune Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

2,280 Total Patients Enrolled

Jen GarciaStudy ChairDirector, Clinical Operations

Sharon VadherStudy ChairDirector, Clinical Operations

Media Library

AR101 (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03292484 — Phase 3

Peanut Allergy Research Study Groups: Treatment Pathway 1, 2, 3, 4, 5

Peanut Allergy Clinical Trial 2023: AR101 Highlights & Side Effects. Trial Name: NCT03292484 — Phase 3

AR101 (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03292484 — Phase 3

Frequently Asked Questions

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

Does this study allow people who are over 50 years old to participate?

"The age range for patients eligible to enroll in this clinical trial is 1 year old to 55 years old. Out of the 246 similar trials, 84 exclude patients under 18 and 162 have an upper limit of 65+."

Answered by AI

Are there many hospitals in North America participating in this research?

"Enrollment for this study is currently happening at 69 different sites, with locations in Denver, Clackamas, Hamilton and other places. If you are interested in enrolling, try to choose a site near your home to limit travel."

Answered by AI

How can I sign up to help with this research project?

"In order to participate in this experiment, potential volunteers must have a peanut allergy and be between 1 Year old and 55. Up to 950 people will be accepted into the trial."

Answered by AI

Are we currently looking for volunteers for this experiment?

"The clinical trial in question is not currently looking for new participants. Based on the information available on clinicaltrials.gov, this study was initially posted on October 11th, 2017 and updated as recently as February 24th, 2022. Even though this particular trial has completed recruitment, there are 266 other trials that patients can participate in."

Answered by AI

What are the odds of experiencing negative side effects from AR101?

"AR101's safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, which suggests that there is evidence of efficacy as well as multiple reports affirming its safety."

Answered by AI

Recent research and studies

The Journal of Allergy and Clinical Immunology: In PracticeJournal

Onset of Eosinophilic Esophagitis During a Clinical Trial Program of Oral Immunotherapy for Peanut Allergy

Nilsson, Caroline, Amy M. Scurlock, Evan S. Dellon, Joshua M. Brostoff, Trinh Pham, Robert Ryan, Kari R. Brown, Daniel C. Adelman, and Seema S. Aceves. 2021. “Onset of Eosinophilic Esophagitis During a Clinical Trial Program of Oral Immunotherapy for Peanut Allergy”. The Journal of Allergy and Clinical Immunology: In Practice. Elsevier BV. doi:10.1016/j.jaip.2021.07.048.

AllergyJournal

Open‐label Follow‐on Study Evaluating the Efficacy, Safety, and Quality of Life with Extended Daily Oral Immunotherapy in Children with Peanut Allergy

Fernandez‐Rivas, Montserrat, Andrea Vereda, Brian P. Vickery, Vibha Sharma, Caroline Nilsson, Antonella Muraro, Jonathan O'B. Hourihane, et al.. 2021. “Open‐label Follow‐on Study Evaluating the Efficacy, Safety, and Quality of Life with Extended Daily Oral Immunotherapy in Children with Peanut Allergy”. Allergy. Wiley. doi:10.1111/all.15027.

clinicaltrials.govStudy

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

2017. "Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03292484.