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The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.
This is a multi-center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of etokimab in adult participants with peanut allergy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etokimab | Experimental | Participants received a single dose of 300 milligrams (mg) etokimab administered by 1-hour intravenous (IV) infusion on Day 1. |
|
| Placebo | Placebo Comparator | Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etokimab | Drug | Humanized monoclonal antibody, administered by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment. | From first dose of study drug up to 45 days. |
| Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge | Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded. | Baseline and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Oral Food Challenge Symptom Score at Day 14 | Oral food challenges were performed at Baseline and Day 14 in accordance with the PRACTALL consensus report. During OFC the OFC Symptom Scoring Assessment Tool was used to assess participants for common symptoms that can be suspected to be an allergic reaction involving the skin, upper respiratory, lower respiratory, gastrointestinal, and cardiovascular systems. Each symptom was scored according to the following scale: Grade 0 = sign or symptom not observed; Grade 1 = mild; Grade 2 = moderate, Grade 3 = severe. The score from each symptom was averaged to calculate the overall score at Baseline and on Day 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Randazzo, MD | AnaptysBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Univ. Medical Center | Palo Alto | California | 94305 | United States | ||
| Asthma, Inc Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31723064 | Result | Chinthrajah S, Cao S, Liu C, Lyu SC, Sindher SB, Long A, Sampath V, Petroni D, Londei M, Nadeau KC. Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy. JCI Insight. 2019 Nov 14;4(22):e131347. doi: 10.1172/jci.insight.131347. |
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On Day 1 eligible participants were randomized in a 3:1 ratio to receive one dose of either etokimab or placebo.
This study was conducted at two clinical sites in the United States between January, 2017 and March, 2018. Inclusion criteria included adult (older than 18 years) male or female participants with a clinical diagnosis of peanut allergy confirmed by an oral food challenge (OFC) at the screening visit (at 7-14 days before treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered by 1-hour intravenous (IV) infusion on Day 1. |
| FG001 | Placebo | Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomization Analysis Set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered by 1-hour IV infusion on Day 1. |
| BG001 | Placebo | Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment. | Safety Analysis Set included all participants who received any portion of etokimab or placebo infusion. | Posted | Count of Participants | Participants | From first dose of study drug up to 45 days. |
From first dose of study drug up to Day 45
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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 | Etokimab | Participants received a single dose of 300 mg etokimab administered by 1-hour IV infusion on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | AnaptysBio, Inc. | 858-362-6295 | info@anaptysbio.com |
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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 | Dec 1, 2017 | Mar 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2018 | Mar 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| Placebo | Drug | Administered by intravenous infusion |
|
| Baseline and Day 14 |
| Maximum Observed Concentration (Cmax) of Etokimab | The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 microgram per milliliter (μg/mL). | Day 1 predose, 0.5 hours after the start of the infusion, end of infusion (EOI), 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Time to Maximum Observed Concentration (Tmax) of Etokimab | The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 μg/mL. | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Area Under the Concentration-time Curve in Serum From Time Zero Extrapolated to Infinite Time (AUC0-inf) for Etokimab | Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz. | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Area Under the Concentration-time Curve in Serum From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for Etokimb | Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation. | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Apparent Terminal Half-life (T1/2) for Etokimab | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Systemic Clearance for Etokimab | Systemic clearance calculated as dose/ AUC(0-inf). | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Volume of Distribution at Steady State Following IV Dosing (Vss) for Etokimab | Volume of distribution at steady state following intravenous dosing, calculated as mean residence time (extrapolated to infinity) multiplied by systemic clearance. | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Volume of Distribution (Vz) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Volume of distribution was estimated by dividing the systemic clearance by apparent terminal rate constant (λz). | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Apparent Terminal Rate Constant (λz) | The terminal elimination rate constant (λz) is defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase. Apparent terminal rate constant was determined by linear regression of the terminal points of the log-linear concentration-time curve. | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
| Seattle |
| Washington |
| 98115 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cumulative Tolerated Peanut Dose During Oral Food Challenge | Oral food challenges were performed at Baseline in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded. | Mean | Standard Deviation | mg |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Etokimab | Participants received a single dose of 300 mg etokimab administered by 1-hour IV infusion on Day 1. |
| OG001 | Placebo | Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. |
|
|
| Primary | Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge | Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded. | Full Analysis Set (FAS) included all participants who received etokimab or placebo who were present in the study until Day 14 with post-baseline OFC results. | Posted | Least Squares Mean | Standard Error | mg | Baseline and Day 14 |
|
|
|
|
| Secondary | Change From Baseline in Oral Food Challenge Symptom Score at Day 14 | Oral food challenges were performed at Baseline and Day 14 in accordance with the PRACTALL consensus report. During OFC the OFC Symptom Scoring Assessment Tool was used to assess participants for common symptoms that can be suspected to be an allergic reaction involving the skin, upper respiratory, lower respiratory, gastrointestinal, and cardiovascular systems. Each symptom was scored according to the following scale: Grade 0 = sign or symptom not observed; Grade 1 = mild; Grade 2 = moderate, Grade 3 = severe. The score from each symptom was averaged to calculate the overall score at Baseline and on Day 14. | FAS population | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 14 |
|
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) of Etokimab | The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 microgram per milliliter (μg/mL). | Pharmacokinetic (PK) Analysis Set included all participants who received etokimab and had at least one post-dose serum concentration data value available for etokimab without any events or protocol deviation deemed to affect PK assessments. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 predose, 0.5 hours after the start of the infusion, end of infusion (EOI), 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of Etokimab | The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 μg/mL. | PK Analysis Set | Posted | Median | Full Range | hours | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Area Under the Concentration-time Curve in Serum From Time Zero Extrapolated to Infinite Time (AUC0-inf) for Etokimab | Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz. | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram (μg)*hour (h)/milliliter (mL) | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Area Under the Concentration-time Curve in Serum From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for Etokimb | Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation. | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/mL | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Apparent Terminal Half-life (T1/2) for Etokimab | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Systemic Clearance for Etokimab | Systemic clearance calculated as dose/ AUC(0-inf). | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Volume of Distribution at Steady State Following IV Dosing (Vss) for Etokimab | Volume of distribution at steady state following intravenous dosing, calculated as mean residence time (extrapolated to infinity) multiplied by systemic clearance. | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Volume of Distribution (Vz) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Volume of distribution was estimated by dividing the systemic clearance by apparent terminal rate constant (λz). | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| Secondary | Apparent Terminal Rate Constant (λz) | The terminal elimination rate constant (λz) is defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase. Apparent terminal rate constant was determined by linear regression of the terminal points of the log-linear concentration-time curve. | PK Analysis Set | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | Placebo | Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. | 0 | 5 | 0 | 5 | 5 | 5 |
| Food allergy | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hangover | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
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| D007154 | Immune System Diseases |