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Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Phase 2 trial testing AR201 powder in Hen Egg Allergy in 15 participants. Terminated before completion.
| Lead sponsor | Aimmune Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 20 August 2019 |
| Primary completion | 16 December 2020 |
| Estimated completion | 28 December 2020 |
| Sites | 11 locations across United States |
Aimmune Therapeutics, Inc. — full company profile →
Adults 4 to 26, any sex, with Hen Egg Allergy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| AR201 Powder | 1 | |
| Placebo Powder | 0 |
| Group | Value | 95% CI |
|---|---|---|
| AR201 Powder | 0 | |
| Placebo Powder | 0 | |
| AR201 Powder | 0 | |
| Placebo Powder | 0 | |
| AR201 Powder | 0 | |
| Placebo Powder | 0 | |
| AR201 Powder | 0 | |
| Placebo Powder | 0 |
Time frame: Approximately 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AR201 Powder | Placebo Powder |
|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | — | — |
| Headache | Nervous system disorders | — | — |
| Reaction | System | AR201 Powder | Placebo Powder |
|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Oral pruritus | Gastrointestinal disorders | — | — |
| Tongue pruritus | Gastrointestinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Lip pruritus | Gastrointestinal disorders | — | — |
| Oral pain | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Oral discomfort | Gastrointestinal disorders | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Petechiae | Skin and subcutaneous tissue disorders | — | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | — | — |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Conjunctivitis | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Otitis media | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hand-foot-and-mouth disease | Infections and infestations | — | — |
| Viral infection | Infections and infestations | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Asthma exercise induced | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Sneezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | — | — |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Subdural haematoma, Headache.
Data from ClinicalTrials.gov NCT04056299 adverse events section.
To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Trials by the same sponsor.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing