Peanut AllergyPhase 3NCT02993107

PALISADE Follow-on Study (ARC004)

A Phase 3 study testing AR101 in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 65 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study. Read more about this study

Who is it for?: Ages 4 to 55 years
Conditions the study is for: Peanut Allergy
What is being tested?: AR101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 388 participants
Where: 65 sitesin 9 countries
Study dates: 29 Dec 2016to 31 May 2019
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 55 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Completion of the ARC003 study
Written informed consent and/or assent from subjects/guardians as appropriate
Use of effective birth control by sexually active female subjects of child-bearing potential

Who cannot join

Early discontinuation from the ARC003 study
Meets any longitudinally applicable ARC003 study exclusion criteria
(Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Trial locations and contacts

65 sites in 9 countries.

Country

City, postcode or hospital

65 sites in 9 countries

United States47 sites

Michigan Medicine, Michigan Clinical Research Unit
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
'Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas, 78723
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Nebraska Medical Research Institute Inc.
Bellevue, Nebraska, 68123
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital, Div. of Allergy & Immunology
Boston, Massachusetts, 02115
IU North Riley Children's Specialist
Carmel, Indiana, 46032
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado, 80122
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599
National Allergy and Asthma Research, LLC
Charleston, South Carolina, 29407
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Health
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
Idaho Allergy and Research, dba Idaho Research
Eagle, Idaho, 83616
Western Sky Medical Research
El Paso, Texas, 79903
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
Children's Mercy on Broadway
Kansas City, Missouri, 64111
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia, 30060
Le Bonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, 38105
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
Mountain View, California, 94040
Central Texas Health Research
New Braunfels, Texas, 78130
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York, 10029
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441
Baker Allergy, Asthma & Dermatology
Portland, Oregon, 97223
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California, 92123
Rady Children's Hospital, San Diego
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94158
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
Sarasota Clinical Research
Sarasota, Florida, 34239
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
Seattle, Washington, 98101
Asthma Inc Clinical Research Center
Seattle, Washington, 98115
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa, Florida, 33613
Banner University of Arizona Medical Center
Tucson, Arizona, 85724
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Canada5 sites

Triple A Lab
Hamilton, Ontario, L8S 1G5
Cheema Research Inc.
Mississauga, Ontario, L5A 3V4
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Ottawa Allergy Research Corp
Ottawa, Ontario, K1G 6C6
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario, M4V 1R2

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Spain3 sites

Hospital Gregorio Marañón
Madrid, 28007
H. Infantil Universitario Niño Jesús
Madrid, 28009
Hospital Clinico San Carlos
Madrid, 28040

Other trials in Spain

United Kingdom3 sites

Guy & St Thomas' NHS foundation Trust
London, SE1 7EH
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, M13 9WL
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, M23 9LT

Other trials in United Kingdom

Germany2 sites

Charité Universitaetsmedizin Berlin
Berlin, 13353
University of Frankfurt
Frankfurt am Main, 60590

Other trials in Germany

Netherlands2 sites

Beatrix Children's Hospital, University Medical Center Groningen
Groningen, 9700 RB
University Medical Center Groningen
Groningen, 9713 GZ

Other trials in Netherlands

Ireland1 site

Cork University Hospital
Cork, T12 DC4A

Other trials in Ireland

Italy1 site

Azienda Ospedaliera di Padova
Padova, 35128

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Sweden1 site

Sachsska Children and Youth Hospital
Stockholm, 118 83

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About this study

Official title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study

Read the detailed description

This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Conditions: Peanut Allergy
Being tested: AR101
Keywords: AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults, Desensitization, PALISADE
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 provided in capsules \& sachets

Study groups in NCT02993107
Study group	Role	What they receive
Group 1 (Placebo Crossovers)	Other	Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC). Receives: Biological: AR101
Group 2 (Active Rollovers)	Other	Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval. Receives: Biological: AR101

What is being measured

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

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
Measured: Up to 126 weeks

Secondary outcomes (1)

Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
Measured: Up to 126 weeks

Timeline

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

29 Dec 201631 May 2019

First posted15 Dec 2016 (estimated)
Study start29 Dec 2016
Primary completion31 May 2019
Study completion31 May 2019

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.
Publications (2)Papers the sponsor has linked to this study.
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: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02993107
Sponsor's protocol ID: ARC004
Status last verified: Mar 2022
First submitted: 8 Dec 2016
Last updated: 17 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
PubMed 36915184
Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
PubMed 34389504

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

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All Peanut Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2022. 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 Adults (PALISADE) Follow-on Study
ClinicalTrials.gov ID: NCT02993107
Acronym / sponsor ID: ARC004
Conditions: Peanut Allergy
Keywords: AR101, Characterized Peanut Allergen, CPNA (Characterized Peanut Allergen), OIT (oral immunotherapy), Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 29 Dec 2016 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 15 Dec 2016 (estimated)
Results: Posted 15 Dec 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 (Placebo Crossovers)	Other	Biological: AR101Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
Group 2 (Active Rollovers)	Other	Biological: AR101Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.

Who may qualify

Ages: 4 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Completion of the ARC003 study
Written informed consent and/or assent from subjects/guardians as appropriate
Use of effective birth control by sexually active female subjects of child-bearing potential

Key exclusion criteria (4 listed)

Early discontinuation from the ARC003 study
Meets any longitudinally applicable ARC003 study exclusion criteria
(Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

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 provided in capsules \& sachets	Biological	Group 1 (Placebo Crossovers), Group 2 (Active Rollovers)

Primary outcome

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Time frame: Up to 126 weeks
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).

1 secondary outcome

Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
Time frame: Up to 126 weeks

Results and safety

Results posted to the registry on 15 Dec 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 (Placebo Crossovers)	113	62
Group 2: Cohort 1 (Active Rollovers)	120	107
Group 2: Cohort 2 (Active Rollovers)	50	39
Group 2: Cohort 3A (Active Rollovers)	35	29
Group 2: Cohort 3B (Active Rollovers)	34	22
Group 2: Cohort 3C (Active Rollovers)	36	21

Primary outcome: Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)

Time frame: Up to 126 weeks. Count of participants. Unit: Participants

Measure	Group 1 (Overall) n = 100	Group 2: Cohort 1 (QD) n = 109	Group 2: Cohort 2 (Overall) n = 46	Group 2: Cohort 3A (QD) n = 31	Group 2: Cohort 3B (Overall) n = 31	Group 2: Cohort 3C (Overall) n = 34
All AEs	98	90	36	27	28	33
SAEs	0	1	0	0	1	1
Grade 1: Mild	37	58	22	15	13	12
Grade 2: Moderate	58	29	14	12	15	18
Grade 3: Severe	3	3	0	0	0	3
Grade 4: Life-Threatening	0	0	0	0	0	0
Grade 5: Death	0	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 28 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Age 4-17 Overall)	0 of 100 (0%)	98 of 100 (98%)	0 of 100
Group 2: Cohort 1 (Age 4-17 QD)	1 of 109 (0.9%)	90 of 109 (82.6%)	0 of 109
Group 2: Cohort 2 (Age 4-17 Overall)	0 of 46 (0%)	36 of 46 (78.3%)	0 of 46
Group 2: Cohort 3A (Age 4-17 QD)	0 of 31 (0%)	27 of 31 (87.1%)	0 of 31
Group 2: Cohort 3B (Age 4-17 Overall)	1 of 31 (3.2%)	28 of 31 (90.3%)	0 of 31
Group 2: Cohort 3C (Age 4-17 Overall)	1 of 34 (2.9%)	33 of 34 (97.1%)	0 of 34
Group 1 (Age 18-55 Overall)	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11
Group 2: Cohort 1 (Age 18-55 QD)	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Group 2: Cohort 2 (Age 18-55 Overall)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Group 2: Cohort 3A (Age 18-55 QD)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Group 2: Cohort 3B (Age 18-55 Overall)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Group 2: Cohort 3C (Age 18-55 Overall)	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36915184Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
Derived from this study: PubMed 34389504Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.
Individual participant dataSharing planned: No

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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 Regulatory Affairs

65 sites in 9 countries: 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 65 sites in 9 countries.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada, Spain, United Kingdom, Germany and 4 more countries. 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 15 Dec 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?

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) (time frame: Up to 126 weeks). 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 NCT02993107, which also lists 2 linked publications.

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 17 Mar 2022.