Peanut AllergyPhase 3NCT03703791

Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 11 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years. Read more about this study

Who is it for?: Ages 4 to 17 years
Conditions the study is for: Peanut Allergy
What is being tested?: AR101
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 11 sitesSpain
Study dates: 24 Oct 2018to 23 Nov 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 4 through 17 years
History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
Positive SPT for peanut
Positive serum IgE to peanut
Written informed consent from the subject's parent/guardian
Written assent from the subject as appropriate
Use of effective birth control by sexually active female subjects of childbearing potential

Who cannot join

Uncertain clinical diagnosis of peanut allergy
History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
Severe persistent asthma or uncontrolled mild or moderate asthma
History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Spain11 sites

Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 8916
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Infantil Universitario Niño Jesus
Madrid, 28009
Hospital Universitario Infanta Leonor
Madrid, 28032
Hospital Clinico San Carlos
Madrid, 28040
Complejo Hospitalario de Navarra
Pamplona, 31008
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026

Other trials in Spain

About this study

Official title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study

Read the detailed description

This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.

Conditions: Peanut Allergy
Being tested: AR101
Keywords: AR101, Characterized Peanut Allergen (CPNA), (Characterized Peanut Allergen) OIT, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adolescents, Desensitization, Quality of Life, OIT (oral immunotherapy), CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)
Medical subject headings: Peanut Hypersensitivity, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR101Biological
AR101 powder

Study groups in NCT03703791
Study group	Role	What they receive
Group 1 (AR101 Treatment + standard of care)	Active comparator	Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance. Receives: Biological: AR101
Group 2 (Standard of Care Treatment)	No intervention	Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.

What is being measured

The primary outcome is the main question the study is designed to answer.

Health-related Quality of Life
The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form).
Measured: 18 months per subject, approximately 30 months for the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201823 Nov 2018

First posted12 Oct 2018
Study start24 Oct 2018
Primary completion23 Nov 2018
Study completion23 Nov 2018

Why it stopped: Sponsor terminated study; no impact on overall benefit risk evaluation of AR101

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peanut AllergyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03703791
Sponsor's protocol ID: ARC009
Other IDs: 2018-000326-58, 2018
Status last verified: Jun 2021
First submitted: 9 Oct 2018
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
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Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
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RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut

All Peanut Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
ClinicalTrials.gov ID: NCT03703791
Acronym / sponsor ID: ARC009
Conditions: Peanut Allergy
Keywords: AR101, Characterized Peanut Allergen (CPNA), (Characterized Peanut Allergen) OIT, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adolescents, Desensitization
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor terminated study; no impact on overall benefit risk evaluation of AR101
Enrolment: 1 participants (actual)
Lead sponsor: Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 24 Oct 2018 (actual)
Primary completion: 23 Nov 2018 (actual)
Study completion: 23 Nov 2018 (actual)
First posted: 12 Oct 2018 (actual)
Results: Posted 13 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 (AR101 Treatment + standard of care)	Active comparator	Biological: AR101Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
Group 2 (Standard of Care Treatment)	No intervention	–Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Age 4 through 17 years
History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
Positive SPT for peanut
Positive serum IgE to peanut
Written informed consent from the subject's parent/guardian

Key exclusion criteria (7 listed)

Uncertain clinical diagnosis of peanut allergy
History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
Severe persistent asthma or uncontrolled mild or moderate asthma
History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AR101AR101 powder	Biological	Group 1 (AR101 Treatment + standard of care)

Primary outcome

Health-related Quality of Life
Time frame: 18 months per subject, approximately 30 months for the study
The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form).

Results and safety

Results posted to the registry on 13 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (AR101 Treatment + Standard of Care)	0	0
Group 2 (Standard of Care Treatment)	1	0

Primary outcome: Health-related Quality of Life

Time frame: 18 months per subject, approximately 30 months for the study

Population analysed: No HRQOL, efficacy, or safety measurements were collected due to the sponsor's decision to terminate the study early.

Adverse events

Time frame: No HRQOL, efficacy, or safety assessments were performed due to the sponsor's decision to terminate the study early.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (AR101 Treatment + Standard of Care)	0 of 0	0 of 0	0
Group 2 (Standard of Care Treatment)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Peanut Allergy

Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
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Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Director of Regulatory Affairs study director

Aimmune Therapeutics

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 11 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related Quality of Life (time frame: 18 months per subject, approximately 30 months for the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.