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The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose ADP101 | Experimental | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
|
| High dose ADP101 | Experimental | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
|
| Pooled Placebo | Experimental | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose ADP101 | Biological | Active powder formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 600mg Desensitization in at Least One Qualifying Food | The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC. | 40 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1000mg Desensitization Threshold in Pediatric ITT Population | Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC. | 40 weeks |
| 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
Severe asthma
Mild or moderate asthma, if uncontrolled or difficult to control
History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema
History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications
History of interstitial lung disease
History of celiac disease
Active autoimmune disease that has required systemic treatment within 3 months
Known malignancy that is progressing or has required active treatment within the past 3 years
Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
Prior/concurrent therapies as follows:
Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
Develops dose-limiting symptoms to placebo during the Screening DBPCFC
Any other condition that might preclude safe participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Mei-Lun Wang, MD | VP of Clinical Development, Alladapt Immunotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Mission Viejo | California | 92691 | United States | ||
| Study Site |
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Eligible participants were randomized in a 2:2:1:1 ratio to 1 of 4 arms, with 2 arms in each dosing regimen (low or high), to receive daily oral doses of study drug (either ADP101 or matching placebo) in a blinded fashion. Data from placebo participants (high-dose or low-dose) was analyzed in a pooled fashion (Pooled Placebo)
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose ADP101 | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2022 | Apr 4, 2024 |
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| High dose ADP101 | Biological | Active powder formulation. |
|
|
| Pooled Placebo | Biological | Placebo powder |
|
|
Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC. |
| 40 weeks |
| 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC. | 40 Weeks |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Study Site | San Diego | California | 92123 | United States |
| Study Site | Denver | Colorado | 80230 | United States |
| Study Site | Tampa | Florida | 33620 | United States |
| Study Site | Atlanta | Georgia | 30329 | United States |
| Study Site | Marietta | Georgia | 30060 | United States |
| Study Site | Normal | Illinois | 61761 | United States |
| Study Site | Ann Arbor | Michigan | 48108 | United States |
| Study Site | Chapel Hill | North Carolina | 27599 | United States |
| Study Site | Cincinnati | Ohio | 45229 | United States |
| Study Site | Happy Valley | Oregon | 97086 | United States |
| Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Study Site | Charleston | South Carolina | 29420 | United States |
| Study Site | Seattle | Washington | 98115 | United States |
| FG001 | High Dose ADP101 | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
| FG002 | Pooled Placebo | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
| COMPLETED |
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| NOT COMPLETED |
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The ITT analysis is defined as all randomized participants, age 4-55 years
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose ADP101 | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
| BG001 | High Dose ADP101 | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101. |
| BG002 | Pooled Placebo | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo (see randomization scheme in pre-assignment details) over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | The primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization | Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization | Mean | Standard Deviation | years |
| ||||||||
| Sex/Gender, Customized | Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization | Count of Participants | Participants |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Primary analysis population (pediatric ITT) | The primary analysis population for the study was the pediatric ITT population, which included participants ages 4-17 years of age at the time of randomization. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 600mg Desensitization in at Least One Qualifying Food | The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC. | The primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization | Posted | Count of Participants | Participants | 40 Weeks |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | 1000mg Desensitization Threshold in Pediatric ITT Population | Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC. | Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization | Posted | Count of Participants | Participants | 40 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC. | Primary analysis population is the pediatric ITT population age 4-17 years at the time of randomization | Posted | Count of Participants | Participants | 40 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population | Proportion of participants with >=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC. | The primary analysis population is the pediatric ITT population, age 4-17 years at the time of randomization | Posted | Count of Participants | Participants | 40 Weeks |
|
Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis.
The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose ADP101, Pediatric Safety Population | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. | 0 | 21 | 0 | 21 | 20 | 21 |
| EG001 | High Dose ADP101, Pediatric Safety Population | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. | 0 | 20 | 1 | 20 | 19 | 20 |
| EG002 | Pooled PBO, Pediatric Safety Population | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. | 0 | 20 | 0 | 20 | 19 | 20 |
| EG003 | Low Dose ADP101, All-participants Safety Population | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. | 0 | 25 | 0 | 25 | 24 | 25 |
| EG004 | High Dose ADP101, All-participants Safety Population | Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. | 0 | 24 | 1 | 24 | 23 | 24 |
| EG005 | Pooled PBO, All-participants Safety Population | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. | 0 | 24 | 0 | 24 | 23 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oral pruritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Paresthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tongue pruritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lip swelling | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hypoaesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lip erythema | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lip pruritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Salivary hypersecretion | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lip oedema | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oral discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Retching | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Throat tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngeal paraesthesia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal pruritis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Throat clearing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Asthma exercise induced | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Ear infection | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis norovirus | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Non-systematic Assessment |
| ||
| Pulpitis dental | Infections and infestations | Non-systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Granuloma annulare | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Perioral dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Seasonal allergy | Immune system disorders | Non-systematic Assessment |
| ||
| Food allergy | Immune system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Chest discomfort | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Feeling abnormal | General disorders | Non-systematic Assessment |
| ||
| Swelling face | General disorders | Non-systematic Assessment |
| ||
| Arthropod sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Vaccination complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Accidental exposure to product | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Scratch | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Eye pruritis | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctivitis allergic | Eye disorders | Non-systematic Assessment |
| ||
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
| ||
| Eye swelling | Eye disorders | Non-systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Non-systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Ear pruritis | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Flushing | Vascular disorders | Non-systematic Assessment |
| ||
| Pallor | Vascular disorders | Non-systematic Assessment |
| ||
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Attention deficit hyperactivity disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Eosinophilic oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Alladapt Immunotherapeutics | 650-420-3900 | info@alladapt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2022 | Apr 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| D021184 | Nut Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| D021182 | Wheat Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| D000067208 | Shellfish Hypersensitivity |
| D007154 | Immune System Diseases |
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
Not provided
Not provided
|
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|
|
|
| OG002 | Pooled PBO | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
|
|
| OG002 | Pooled PBO | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
|
|
| OG002 | Pooled PBO | Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active. |
|
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