Trial Outcomes & Findings for Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy (NCT NCT04056299)
NCT ID: NCT04056299
Last Updated: 2022-03-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
9-12 months
Results posted on
2022-03-10
Participant Flow
Participant milestones
| Measure |
AR201 Powder
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules
|
Placebo Powder
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder: Placebo powder provided in capsules
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
AR201 Powder
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules
|
Placebo Powder
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder: Placebo powder provided in capsules
|
|---|---|---|
|
Overall Study
Sponsor discontinued study
|
3
|
3
|
Baseline Characteristics
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Baseline characteristics by cohort
| Measure |
AR201 Powder
n=9 Participants
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules
|
Placebo Powder
n=6 Participants
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder: Placebo powder provided in capsules
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.0 years
n=5 Participants
|
5.5 years
n=7 Participants
|
7.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9-12 monthsPopulation: The study was prematurely terminated due to difficulties in meeting enrollment goals due to the Coronavirus Disease 2019 (COVID-19) pandemic. As a consequence, all prespecified efficacy endpoint analysis were not performed, and the exit DBPCFC was optional and limited to subjects who completed at least 9 months of study treatment including at least 4 weeks at 300 mg/day, and tolerated the 300 mg/day dose for approximately 2 consecutive weeks before the exit DBPCFC.
Outcome measures
| Measure |
AR201 Powder
n=9 Participants
Study product provided as dried egg white in pull-apart capsules.
AR201 powder in capsules: AR201 powder (Hen Egg allergen formulation) formulated to contain dried egg white at different dosage strengths.
|
Placebo Powder
n=6 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Placebo powder formulated to match the color and texture of dried egg white.
|
|---|---|---|
|
Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9-12 monthsPopulation: The study was prematurely terminated due to difficulties in meeting enrollment goals due to the COVID-19 pandemic. As a consequence, all prespecified efficacy endpoint analysis were not performed, and the exit DBPCFC was optional and limited to subjects who completed at least 9 months of study treatment including at least 4 weeks at 300 mg/day, and tolerated the 300 mg/day dose for approximately 2 consecutive weeks before the exit DBPCFC.
Outcome measures
| Measure |
AR201 Powder
n=9 Participants
Study product provided as dried egg white in pull-apart capsules.
AR201 powder in capsules: AR201 powder (Hen Egg allergen formulation) formulated to contain dried egg white at different dosage strengths.
|
Placebo Powder
n=6 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Placebo powder formulated to match the color and texture of dried egg white.
|
|---|---|---|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
None
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
1 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
3 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
10 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
30 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
100 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
300 mg
|
2 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
600 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
1000 mg
|
0 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
2000 mg
|
1 Participants
|
0 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Did not have an exit DBPCFC
|
6 Participants
|
6 Participants
|
Adverse Events
AR201 Powder
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Powder
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR201 Powder
n=9 participants at risk
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules
|
Placebo Powder
n=6 participants at risk
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder: Placebo powder provided in capsules
|
|---|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
Other adverse events
| Measure |
AR201 Powder
n=9 participants at risk
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
AR201 powder: AR201 powder (Hen Egg allergen formulation) provided in capsules
|
Placebo Powder
n=6 participants at risk
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Placebo powder: Placebo powder provided in capsules
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
55.6%
5/9 • Approximately 9 months
|
33.3%
2/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Approximately 9 months
|
50.0%
3/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Lip pruritus
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Oral pruritus
|
11.1%
1/9 • Approximately 9 months
|
33.3%
2/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Tongue pruritus
|
11.1%
1/9 • Approximately 9 months
|
33.3%
2/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
44.4%
4/9 • Approximately 9 months
|
33.3%
2/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Approximately 9 months
|
50.0%
3/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Infections and infestations
Otitis media
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • Approximately 9 months
|
33.3%
2/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Eye disorders
Conjunctival hyperaemia
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Eye disorders
Eye pruritus
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Eye disorders
Blepharitis
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
General disorders
Malaise
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
General disorders
Fatigue
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Concussion
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Immune system disorders
Hypersensitivity
|
11.1%
1/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Psychiatric disorders
Merycism
|
11.1%
1/9 • Approximately 9 months
|
0.00%
0/6 • Approximately 9 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Approximately 9 months
|
16.7%
1/6 • Approximately 9 months
|
Additional Information
Director of Regulatory Affairs
Aimmune Therapeutics, Inc.
Phone: 650-409-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. * 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
- Publication restrictions are in place
Restriction type: OTHER