Peanut AllergyPhase 2ARC001NCT01987817
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
A Phase 2 study testing AR101 powder provided in capsules in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 8 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals. Read more about this study
- Who is it for?
- Ages 4 to 26 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- AR101 powder provided in capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Feb 2014to 7 Jan 2015
- Phase
- Phase 2
- 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 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 4 through 26 years, inclusive
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut >3 mm compared to control
- Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
- Use of birth control by females of child-bearing potential
Who cannot join
- History of Cardiovascular disease
- History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
- History of other chronic disease
- History of eosinophilic gastrointestinal disease
- Severe asthma
- Mild or moderate asthma if uncontrolled
Show all 11Show fewer
- Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy
- Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)
- Pregnancy, lactation
- Having the same place of residence as another study subject
- Participation in an interventional clinical trial 30 days prior to randomization
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mount Sinai Medical Center
New York, New York, 10029
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UC San Diego
San Diego, California, 92123
About this study
Official title: Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
Read the detailed description
This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.
- Conditions
- Peanut Allergy
- Being tested
- AR101 powder provided in capsules, Placebo powder provided in capsules
- Keywords
- Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Allergy, Peanut Allergy, Peanut-Allergic Children, Children, Peanut-Allergic Adults
- 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.
AR101 powder provided in capsulesBiological
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsulesBiological
Study product formulated to contain only inactive ingredients for use as defined in the protocol
| Study group | Role | What they receive |
|---|---|---|
| AR101 powder provided in capsules | Experimental | Study product provided as peanut protein in pull-apart capsules Receives: Biological: AR101 powder provided in capsules |
| Placebo powder provided in capsules | Placebo comparator | Placebo formulation in pull-apart capsules containing only inactive ingredients Receives: Biological: Placebo powder provided in capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
Measured: 6-9 Months
Secondary outcomes (5)
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
Measured: 6-9 months
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Measured: 6-9 months
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Measured: 6-9 months
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Measured: 6-9 months
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Measured: Baseline, 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start6 Feb 2014
- Primary completion7 Jan 2015
- Study completion7 Jan 2015
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director of Regulatory Affairs, Study chair, Aimmune Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987817
- Sponsor's protocol ID
- ARC001
- Acronym
- ARC001
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2013
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
- ClinicalTrials.gov ID
- NCT01987817
- Acronym / sponsor ID
- ARC001 / ARC001
- Conditions
- Peanut Allergy
- Keywords
- Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Allergy, Peanut Allergy, Peanut-Allergic Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aimmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 7 Jan 2015 (actual)
- Study completion
- 7 Jan 2015 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
Detailed description
This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR101 powder provided in capsules | Experimental | Biological: AR101 powder provided in capsulesStudy product provided as peanut protein in pull-apart capsules |
| Placebo powder provided in capsules | Placebo comparator | Biological: Placebo powder provided in capsulesPlacebo formulation in pull-apart capsules containing only inactive ingredients |
Who may qualify
- Ages
- 4 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 4 through 26 years, inclusive
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut >3 mm compared to control
- Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
- Use of birth control by females of child-bearing potential
Key exclusion criteria (11 listed)
- History of Cardiovascular disease
- History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
- History of other chronic disease
- History of eosinophilic gastrointestinal disease
- Severe asthma
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 |
|---|---|---|
| AR101 powder provided in capsulesStudy product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Biological | AR101 powder provided in capsules |
| Placebo powder provided in capsulesStudy product formulated to contain only inactive ingredients for use as defined in the protocol | Biological | Placebo powder provided in capsules |
Primary outcome
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
Time frame: 6-9 Months
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
5 secondary outcomes
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
Time frame: 6-9 months
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Time frame: 6-9 months
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Time frame: Baseline, 6-9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 chair
Aimmune Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR101 powder provided in capsules in people with Peanut Allergy, run by Aimmune Therapeutics, Inc. at 8 sites in United States.
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 5 inclusion and 11 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Nov 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?
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC (time frame: 6-9 Months). 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 NCT01987817, which also lists 1 linked publication.
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 30 Nov 2021.