ARTEMIS Peanut Allergy In Children
Sponsor
Aimmune Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03201003
Collaborator
(none)
175
18
2
20.1
9.7
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
Study Design
Study Type:
Interventional
Actual Enrollment
:
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
AR101 Trial in Europe Measuring Oral Immunotherapy Success in Peanut Allergic Children (ARTEMIS)
Actual Study Start Date
:
Jun 12, 2017
Actual Primary Completion Date
:
Feb 15, 2019
Actual Study Completion Date
:
Feb 15, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AR101 AR101 powder provided in capsules & sachets |
Biological: AR101 powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
| Placebo Comparator: Placebo Placebo powder provided in capsules & sachets |
Other: Placebo powder provided in capsules & sachets
Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
Outcome Measures
Primary Outcome Measures
- The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. [Approximately 9 months]
The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Secondary Outcome Measures
- Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge [Approximately 9 months]
The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
- Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. [Approximately 9 months]
The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
- Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge [Approximately 9 months]
The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower)
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Age 4 to 17 years, inclusive
-
Clinical history of allergy to peanuts
-
Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
-
Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
-
Written informed consent from the subject's parent/guardian
-
Written assent from the subject as appropriate (per local regulatory requirements)
-
Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
-
History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
-
History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
-
History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
-
History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
-
History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
-
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon | Bordeaux Cedex | France | 33076 | |
| 2 | Hopital Saint Vincent de Paul, Service d'Allergologie | Lille Cedex | France | 59020 | |
| 3 | Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital | Lille cedex | France | 59037 | |
| 4 | Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg | Strasbourg Cedex | France | 67091 | |
| 5 | Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie | Berlin | Germany | 13353 | |
| 6 | University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose | Frankfurt am Main | Germany | 60590 | |
| 7 | UCC Dept. of Paediatrics and Child, Cork University Hospital | Cork | Ireland | ||
| 8 | National Children's Research Centre, Our Lady's Children's Hospital Crumlin | Dublin | Ireland | D12 V004 | |
| 9 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 10 | Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46 | Madrid | Spain | 28007 | |
| 11 | H. Infantil Universitario Niño Jesús, Servicio de Alergia | Madrid | Spain | 28009 | |
| 12 | Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 13 | Sachsska Children and Youth Hospital | Stockholm | Sweden | 118 83 | |
| 14 | James Paget University Hospital | Gorleston-on-Sea | Norfolk | United Kingdom | NR31 6LA |
| 15 | Guy & St Thomas' Hospital, NHS Foundation Trust | London | United Kingdom | SE1 7EH | |
| 16 | St. Mary's Hospital | London | United Kingdom | W2 1NY | |
| 17 | Royal Manchester Children's Hospital | Manchester | United Kingdom | M13 9WL | |
| 18 | University Hospitals Southampton Foundation NHS Trust | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Aimmune Therapeutics, Inc.
Investigators
- Study Director: Director of Regulatory Affairs, Aimmune Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03201003
Other Study ID Numbers:
- ARC010
First Posted:
Jun 28, 2017
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 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
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Aimmune Therapeutics, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AR101 | Placebo |
|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| Period Title: Overall Study | ||
| STARTED | 132 | 43 |
| COMPLETED | 106 | 40 |
| NOT COMPLETED | 26 | 3 |
Baseline Characteristics
| Arm/Group Title | AR101 | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. | Total of all reporting groups |
| Overall Participants | 132 | 43 | 175 |
| Age, Customized (Count of Participants) | |||
| Children (4-11 years) |
97
73.5%
|
30
69.8%
|
127
72.6%
|
| Adolescents (12-17 years) |
35
26.5%
|
13
30.2%
|
48
27.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
64
48.5%
|
16
37.2%
|
80
45.7%
|
| Male |
68
51.5%
|
27
62.8%
|
95
54.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
1.5%
|
0
0%
|
2
1.1%
|
| Not Hispanic or Latino |
119
90.2%
|
39
90.7%
|
158
90.3%
|
| Unknown or Not Reported |
11
8.3%
|
4
9.3%
|
15
8.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
0.8%
|
1
2.3%
|
2
1.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
106
80.3%
|
34
79.1%
|
140
80%
|
| More than one race |
2
1.5%
|
1
2.3%
|
3
1.7%
|
| Unknown or Not Reported |
23
17.4%
|
7
16.3%
|
30
17.1%
|
| Region of Enrollment (participants) [Number] | |||
| Sweden |
8
6.1%
|
3
7%
|
11
6.3%
|
| Ireland |
20
15.2%
|
6
14%
|
26
14.9%
|
| United Kingdom |
46
34.8%
|
13
30.2%
|
59
33.7%
|
| Italy |
5
3.8%
|
3
7%
|
8
4.6%
|
| France |
12
9.1%
|
5
11.6%
|
17
9.7%
|
| Germany |
21
15.9%
|
7
16.3%
|
28
16%
|
| Spain |
20
15.2%
|
6
14%
|
26
14.9%
|
Outcome Measures
| Title | The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. |
|---|---|
| Description | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. |
| Time Frame | Approximately 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AR101 | Placebo |
|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| Measure Participants | 132 | 43 |
| Count of Participants [Participants] |
77
58.3%
|
1
2.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101, Placebo |
|---|---|---|
| Comments | Treatment difference at 1000 mg | |
| 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 | 56.0 | |
| Confidence Interval |
(2-Sided) 95% 44.1 to 65.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge |
|---|---|
| Description | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. |
| Time Frame | Approximately 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AR101 | Placebo |
|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| Measure Participants | 132 | 43 |
| Count of Participants [Participants] |
90
68.2%
|
4
9.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101, Placebo |
|---|---|---|
| Comments | Treatment difference at 600 mg | |
| 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 | 58.9 | |
| Confidence Interval |
(2-Sided) 95% 44.2 to 69.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. |
|---|---|
| Description | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. |
| Time Frame | Approximately 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AR101 | Placebo |
|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| Measure Participants | 132 | 43 |
| Count of Participants [Participants] |
97
73.5%
|
7
16.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101, Placebo |
|---|---|---|
| Comments | Treatment difference at 300 mg | |
| 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 | 57.2 | |
| Confidence Interval |
(2-Sided) 95% 41.2 to 69.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge |
|---|---|
| Description | The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower) |
| Time Frame | Approximately 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AR101 | Placebo |
|---|---|---|
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| Measure Participants | 132 | 43 |
| None |
47
35.6%
|
0
0%
|
| Mild |
55
41.7%
|
16
37.2%
|
| Moderate |
24
18.2%
|
20
46.5%
|
| Severe or higher |
6
4.5%
|
7
16.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AR101, Placebo |
|---|---|---|
| Comments | Treatment difference in Maximum Severity | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country | |
Adverse Events
| Time Frame | Approximately 9 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | AR101 | Placebo | ||
| Arm/Group Description | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. | ||
All Cause Mortality |
||||
| AR101 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/132 (0%) | 0/43 (0%) | ||
Serious Adverse Events |
||||
| AR101 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/132 (0.8%) | 2/43 (4.7%) | ||
| Infections and infestations | ||||
| Bronchitis bacterial | 0/132 (0%) | 0 | 1/43 (2.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Intentional overdose | 1/132 (0.8%) | 1 | 0/43 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchospasm | 0/132 (0%) | 0 | 1/43 (2.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| AR101 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 130/132 (98.5%) | 42/43 (97.7%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 8/132 (6.1%) | 10 | 1/43 (2.3%) | 1 |
| Ear and labyrinth disorders | ||||
| Ear pain | 14/132 (10.6%) | 21 | 0/43 (0%) | 0 |
| Motion sickness | 4/132 (3%) | 5 | 3/43 (7%) | 4 |
| Eye disorders | ||||
| Eye pruritus | 24/132 (18.2%) | 37 | 8/43 (18.6%) | 12 |
| Eye swelling | 11/132 (8.3%) | 18 | 3/43 (7%) | 7 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 88/132 (66.7%) | 835 | 19/43 (44.2%) | 126 |
| Nausea | 58/132 (43.9%) | 437 | 11/43 (25.6%) | 31 |
| Paraesthesia oral | 52/132 (39.4%) | 961 | 9/43 (20.9%) | 49 |
| Vomiting | 53/132 (40.2%) | 120 | 10/43 (23.3%) | 17 |
| Oral pruritus | 28/132 (21.2%) | 236 | 1/43 (2.3%) | 1 |
| Lip swelling | 20/132 (15.2%) | 112 | 4/43 (9.3%) | 6 |
| Lip pruritus | 16/132 (12.1%) | 97 | 2/43 (4.7%) | 2 |
| Abdominal discomfort | 17/132 (12.9%) | 120 | 2/43 (4.7%) | 3 |
| Tongue pruritus | 12/132 (9.1%) | 133 | 5/43 (11.6%) | 11 |
| Lip oedema | 7/132 (5.3%) | 20 | 1/43 (2.3%) | 2 |
| Diarrhoea | 16/132 (12.1%) | 26 | 8/43 (18.6%) | 19 |
| Abdominal pain upper | 14/132 (10.6%) | 44 | 5/43 (11.6%) | 6 |
| Lip pain | 7/132 (5.3%) | 21 | 0/43 (0%) | 0 |
| General disorders | ||||
| Pyrexia | 29/132 (22%) | 41 | 14/43 (32.6%) | 19 |
| Fatigue | 13/132 (9.8%) | 36 | 5/43 (11.6%) | 5 |
| Malaise | 8/132 (6.1%) | 12 | 3/43 (7%) | 3 |
| Chest discomfort | 7/132 (5.3%) | 15 | 1/43 (2.3%) | 1 |
| Immune system disorders | ||||
| Systemic allergic reaction | 16/132 (12.1%) | 22 | 1/43 (2.3%) | 2 |
| Seasonal allergy | 10/132 (7.6%) | 20 | 2/43 (4.7%) | 2 |
| Infections and infestations | ||||
| Conjunctivitis | 15/132 (11.4%) | 31 | 5/43 (11.6%) | 25 |
| Nasopharyngitis | 44/132 (33.3%) | 77 | 12/43 (27.9%) | 21 |
| Rhinitis | 20/132 (15.2%) | 51 | 7/43 (16.3%) | 17 |
| Viral infection | 18/132 (13.6%) | 24 | 7/43 (16.3%) | 10 |
| Upper respiratory tract infection | 17/132 (12.9%) | 21 | 11/43 (25.6%) | 12 |
| Gastroenteritis | 12/132 (9.1%) | 13 | 5/43 (11.6%) | 6 |
| Gastroenteritis viral | 7/132 (5.3%) | 8 | 0/43 (0%) | 0 |
| Influenza | 4/132 (3%) | 4 | 3/43 (7%) | 3 |
| Respiratory tract infection | 3/132 (2.3%) | 4 | 3/43 (7%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Pain in extremity | 11/132 (8.3%) | 15 | 1/43 (2.3%) | 1 |
| Nervous system disorders | ||||
| Headache | 46/132 (34.8%) | 128 | 19/43 (44.2%) | 65 |
| Dizziness | 4/132 (3%) | 4 | 3/43 (7%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Throat irritation | 57/132 (43.2%) | 659 | 8/43 (18.6%) | 25 |
| Sneezing | 43/132 (32.6%) | 157 | 7/43 (16.3%) | 24 |
| Cough | 66/132 (50%) | 166 | 24/43 (55.8%) | 53 |
| Rhinorrhoea | 34/132 (25.8%) | 89 | 10/43 (23.3%) | 22 |
| Nasal congestion | 23/132 (17.4%) | 63 | 8/43 (18.6%) | 12 |
| Dyspnoea | 15/132 (11.4%) | 40 | 3/43 (7%) | 11 |
| Wheezing | 22/132 (16.7%) | 45 | 3/43 (7%) | 8 |
| Throat tightness | 10/132 (7.6%) | 31 | 1/43 (2.3%) | 8 |
| Nasal pruritus | 11/132 (8.3%) | 19 | 3/43 (7%) | 3 |
| Oropharyngeal pain | 37/132 (28%) | 99 | 12/43 (27.9%) | 18 |
| Pharyngeal paraesthesia | 7/132 (5.3%) | 37 | 2/43 (4.7%) | 3 |
| Asthma | 7/132 (5.3%) | 12 | 3/43 (7%) | 7 |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 67/132 (50.8%) | 300 | 14/43 (32.6%) | 62 |
| Urticaria | 48/132 (36.4%) | 156 | 9/43 (20.9%) | 27 |
| Erythema | 34/132 (25.8%) | 69 | 5/43 (11.6%) | 5 |
| Rash | 21/132 (15.9%) | 38 | 8/43 (18.6%) | 18 |
| Angioedema | 13/132 (9.8%) | 87 | 4/43 (9.3%) | 7 |
| Eczema | 12/132 (9.1%) | 25 | 11/43 (25.6%) | 18 |
| Dry skin | 6/132 (4.5%) | 8 | 4/43 (9.3%) | 5 |
| Dermatitis atopic | 3/132 (2.3%) | 3 | 4/43 (9.3%) | 5 |
| Vascular disorders | ||||
| Flushing | 15/132 (11.4%) | 42 | 1/43 (2.3%) | 3 |
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:
NCT03201003
Other Study ID Numbers:
- ARC010
First Posted:
Jun 28, 2017
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021