ARC001: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Sponsor
Aimmune Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01987817
Collaborator
(none)
56
8
2
11
7
0.6
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
Actual Study Start Date
:
Feb 6, 2014
Actual Primary Completion Date
:
Jan 7, 2015
Actual Study Completion Date
:
Jan 7, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AR101 powder provided in capsules Study product provided as peanut protein in pull-apart capsules |
Biological: AR101 powder provided in capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
| Placebo Comparator: Placebo powder provided in capsules Placebo formulation in pull-apart capsules containing only inactive ingredients |
Biological: Placebo powder provided in capsules
Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
Outcome Measures
Primary Outcome Measures
- 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 [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)
Secondary Outcome Measures
- Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC [6-9 months]
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
- Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC [6-9 months]
- Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC [6-9 months]
- Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC [6-9 months]
- Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline [Baseline, 6-9 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
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:
-
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202 |
| 2 | UC San Diego | San Diego | California | United States | 92123 |
| 3 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 4 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 5 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 6 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 7 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | Children's Medical Center Dallas | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- Aimmune Therapeutics, Inc.
Investigators
- Study Chair: Director of Regulatory Affairs, Aimmune Therapeutics, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01987817
Other Study ID Numbers:
- ARC001
First Posted:
Nov 19, 2013
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aimmune Therapeutics, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 67 subjects signed the informed consent and went through the screening process. 11 subjects failed screening, resulting in 56 subjects being enrolled and initially randomized. The randomized population comprised 29 subjects in the AR101 group and 27 subjects in the placebo group. The final intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) had one fewer subject in the placebo group (n=26). |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Period Title: Overall Study | ||
| STARTED | 29 | 27 |
| COMPLETED | 23 | 26 |
| NOT COMPLETED | 6 | 1 |
Baseline Characteristics
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | Total |
|---|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol | Total of all reporting groups |
| Overall Participants | 29 | 26 | 55 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
7.0
|
8.0
|
8.0
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
31%
|
10
38.5%
|
19
34.5%
|
| Male |
20
69%
|
16
61.5%
|
36
65.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
29
100%
|
26
100%
|
55
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
3.8%
|
1
1.8%
|
| Asian |
1
3.4%
|
1
3.8%
|
2
3.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
3.4%
|
2
7.7%
|
3
5.5%
|
| White |
26
89.7%
|
20
76.9%
|
46
83.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
3.4%
|
2
7.7%
|
3
5.5%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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) |
| Time Frame | 6-9 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| Count of Participants [Participants] |
23
79.3%
|
5
19.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101 Powder Provided in Capsules, Placebo Powder Provided in Capsules |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 60.0 | |
| Confidence Interval |
(2-Sided) 95% 35 to 79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC |
|---|---|
| Description | The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| Least Squares Mean (95% Confidence Interval) [Change from baseline in MTD (log10 mg)] |
1.254
|
0.341
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101 Powder Provided in Capsules, Placebo Powder Provided in Capsules |
|---|---|---|
| Comments | MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption. | |
| Method | ANCOVA | |
| Comments | Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment & MTD at baseline (log10 mg). | |
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | 0.912 | |
| Confidence Interval |
(2-Sided) 95% 0.5184 to 1.3065 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC |
|---|---|
| Description | |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| 0.3 mg |
0
0%
|
1
3.8%
|
| 3 mg |
2
6.9%
|
2
7.7%
|
| 10 mg |
3
10.3%
|
7
26.9%
|
| 30 mg |
1
3.4%
|
5
19.2%
|
| 100 mg |
0
0%
|
6
23.1%
|
| 300 mg |
5
17.2%
|
5
19.2%
|
| 600 mg |
18
62.1%
|
0
0%
|
| Title | Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC |
|---|---|
| Description | |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group. |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| Peanut-Specific IgE, Baseline |
32.571
|
53.839
|
| Peanut-Specific IgE, Exit |
36.889
|
57.060
|
| Relative Change From Baseline of Peanut-Specific IgGE |
1.231
|
1.060
|
| Title | Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC |
|---|---|
| Description | |
| Time Frame | 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group. |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| Peanut-Specific IgG4, Baseline |
0.734
|
0.510
|
| Peanut-Specific IgG4, Exit |
3.609
|
0.540
|
| Relative Change From Baseline of Peanut-Specific IgG4 |
5.068
|
1.066
|
| Title | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline |
|---|---|
| Description | |
| Time Frame | Baseline, 6-9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) |
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol |
| Measure Participants | 29 | 26 |
| Peanut Wheal, Baseline (mm) |
14.1
|
13.7
|
| Peanut Wheal, Exit (mm) |
7.1
|
11.8
|
| Change in Peanut Wheel from Baseline (mm) |
-7.0
|
-1.8
|
Adverse Events
| Time Frame | 6-9 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | ||
| Arm/Group Description | Study product provided as peanut protein in pull-apart capsules. AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | Placebo formulation in pull-apart capsules containing only inactive ingredients Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol | ||
All Cause Mortality |
||||
| AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/26 (0%) | ||
Serious Adverse Events |
||||
| AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/29 (3.4%) | 1/26 (3.8%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/29 (3.4%) | 1/26 (3.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
| AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/29 (96.6%) | 22/26 (84.6%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 2/29 (6.9%) | 0/26 (0%) | ||
| Tympanic membrane perforation | 0/29 (0%) | 1/26 (3.8%) | ||
| Eye disorders | ||||
| Conjunctivitis allergic | 1/29 (3.4%) | 0/26 (0%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 4/29 (13.8%) | 2/26 (7.7%) | ||
| Diarrhoea | 1/29 (3.4%) | 3/26 (11.5%) | ||
| Nausea | 3/29 (10.3%) | 1/26 (3.8%) | ||
| Abdominal pain | 2/29 (6.9%) | 1/26 (3.8%) | ||
| Abdominal pain upper | 1/29 (3.4%) | 2/26 (7.7%) | ||
| Dental caries | 1/29 (3.4%) | 0/26 (0%) | ||
| Toothache | 0/29 (0%) | 1/26 (3.8%) | ||
| General disorders | ||||
| Pyrexia | 5/29 (17.2%) | 4/26 (15.4%) | ||
| Malaise | 0/29 (0%) | 2/26 (7.7%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 26/29 (89.7%) | 14/26 (53.8%) | ||
| Infections and infestations | ||||
| Upper Respiratory Tract Infection | 2/29 (6.9%) | 5/26 (19.2%) | ||
| Viral Infection | 3/29 (10.3%) | 1/26 (3.8%) | ||
| Pharyngitis streptococcal | 2/29 (6.9%) | 1/26 (3.8%) | ||
| Croup Infectious | 1/29 (3.4%) | 0/26 (0%) | ||
| Ear infection | 0/29 (0%) | 1/26 (3.8%) | ||
| Ear lobe infection | 1/29 (3.4%) | 0/26 (0%) | ||
| Gastroenteritis | 0/29 (0%) | 1/26 (3.8%) | ||
| Gastroenteritis viral | 1/29 (3.4%) | 0/26 (0%) | ||
| Molluscum contagiosum | 1/29 (3.4%) | 0/26 (0%) | ||
| Nasopharyngitis | 1/29 (3.4%) | 0/26 (0%) | ||
| Otitis externa | 1/29 (3.4%) | 0/26 (0%) | ||
| Tinea infection | 1/29 (3.4%) | 0/26 (0%) | ||
| Viral upper respiratory tract infection | 1/29 (3.4%) | 0/26 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Arthropod stings | 1/29 (3.4%) | 1/26 (3.8%) | ||
| Ligament sprain | 0/29 (0%) | 2/26 (7.7%) | ||
| Animal bite | 0/29 (0%) | 1/26 (3.8%) | ||
| Arthropod bite | 1/29 (3.4%) | 0/26 (0%) | ||
| Ankle fracture | 0/29 (0%) | 1/26 (3.8%) | ||
| Contusion | 1/29 (3.4%) | 0/26 (0%) | ||
| Excoriation | 1/29 (3.4%) | 0/26 (0%) | ||
| Forearm fracture | 0/29 (0%) | 1/26 (3.8%) | ||
| Skeletal injury | 0/29 (0%) | 1/26 (3.8%) | ||
| Upper limb fracture | 1/29 (3.4%) | 0/26 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/29 (0%) | 1/26 (3.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscle twitching | 0/29 (0%) | 1/26 (3.8%) | ||
| Nervous system disorders | ||||
| Headache | 3/29 (10.3%) | 3/26 (11.5%) | ||
| Presyncope | 1/29 (3.4%) | 1/26 (3.8%) | ||
| Somnolence | 2/29 (6.9%) | 0/26 (0%) | ||
| Dizziness | 0/29 (0%) | 1/26 (3.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Nasal congestion | 2/29 (6.9%) | 3/26 (11.5%) | ||
| Cough | 2/29 (6.9%) | 2/26 (7.7%) | ||
| Oropharyngeal pain | 3/29 (10.3%) | 1/26 (3.8%) | ||
| Asthma | 0/29 (0%) | 1/26 (3.8%) | ||
| Epistaxis | 0/29 (0%) | 1/26 (3.8%) | ||
| Rhinorrhoea | 0/29 (0%) | 1/26 (3.8%) | ||
| Throat irritation | 0/29 (0%) | 1/26 (3.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Urticaria | 3/29 (10.3%) | 2/26 (7.7%) | ||
| Dermatitis contact | 0/29 (0%) | 1/26 (3.8%) | ||
| Papule | 0/29 (0%) | 1/26 (3.8%) | ||
| Rash | 1/29 (3.4%) | 0/26 (0%) | ||
| Rash papular | 1/29 (3.4%) | 0/26 (0%) | ||
| Surgical and medical procedures | ||||
| Tooth extraction | 0/29 (0%) | 1/26 (3.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Institutions cannot publish until the multi-center sponsor publication is published Or, institutions cannot publish until 18 months after study completion And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
Results Point of Contact
| Name/Title | Director of Regulatory Affairs |
|---|---|
| Organization | Aimmune Therapeutics, Inc. |
| Phone | 650-409-5164 |
| RegulatoryAffairs@aimmune.com |
Responsible Party:
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01987817
Other Study ID Numbers:
- ARC001
First Posted:
Nov 19, 2013
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021