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Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Phase 3 trial testing AR101 powder provided in capsules & sachets in Peanut Allergy in 555 participants. Completed in 2 July 2018.
| Lead sponsor | Aimmune Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 555 |
| Start date | 22 December 2015 |
| Primary completion | 21 December 2017 |
| Estimated completion | 2 July 2018 |
| Sites | 69 locations across Denmark, Italy, Netherlands, Sweden, Ireland, United Kingdom, Germany, Canada |
Aimmune Therapeutics, Inc. — full company profile →
Adults 4 to 55, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage 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.
| Group | Value | 95% CI |
|---|---|---|
| AR101 | 250 | |
| Placebo | 5 |
The percentage 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.
| Group | Value | 95% CI |
|---|---|---|
| AR101 | 187 | |
| Placebo | 3 |
The percentage 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.
| Group | Value | 95% CI |
|---|---|---|
| AR101 | 285 | |
| Placebo | 10 |
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).
| Group | Value | 95% CI |
|---|---|---|
| AR101 | 140 | |
| Placebo | 3 | |
| AR101 | 119 | |
| Placebo | 35 | |
| AR101 | 94 | |
| Placebo | 73 | |
| AR101 | 19 | |
| Placebo | 13 |
Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AR101 (Age 4-17) | Placebo (Age 4-17) | AR101 (Age 18-55) | Placebo (Age 18-55) |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | — | — | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — |
| Gastroenteritis viral | Infections and infestations | — | — | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — | — | — |
| Humerous fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | — | — | — | — |
| Reaction | System | AR101 (Age 4-17) | Placebo (Age 4-17) | AR101 (Age 18-55) | Placebo (Age 18-55) |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Oral pruritus | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Sneezing | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Paraesthesia oral | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Anaphylactic reaction | Immune system disorders | — | — | — | — |
| Viral infection | Infections and infestations | — | — | — | — |
| Flushing | Vascular disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Asthma | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Swelling face | Skin and subcutaneous tissue disorders | — | — | — | — |
| Lip swelling | Gastrointestinal disorders | — | — | — | — |
| Tongue pruritus | Gastrointestinal disorders | — | — | — | — |
| Lip pruritus | Gastrointestinal disorders | — | — | — | — |
| Ocular hyperaemia | Eye disorders | — | — | — | — |
| Eye pruritus | Eye disorders | — | — | — | — |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — | — |
| Ear pruritus | Ear and labyrinth disorders | — | — | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
Most-reported serious reactions: Anaphylactic reaction, Asthma, Gastroenteritis, Gastroenteritis viral, Pharyngitis streptococcal, Concussion, Humerous fracture, Syncope.
Data from ClinicalTrials.gov NCT02635776 adverse events section.
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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