Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy
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|ClinicalTrials.gov Identifier: NCT02920021|
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : June 26, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: ANB020 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
ANB020, administration of ANB020
Placebo Comparator: Placebo
Placebo, administration of Placebo
- Safety of ANB020 in adult patients with peanut allergy [ Time Frame: through study completion, an average of 60 days ]Occurrence of adverse events
- Change in Laboratory Values [ Time Frame: through study completion, an average of 60 days ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Clinical Scores of oral food challenge symptoms [ Time Frame: At pre-treatment and Day 14 ]Change in clinical scores of the oral food challenge symptoms before and after treatment
- Change in serum levels of specific cytokines [ Time Frame: through study completion, an average of 60 days ]Change in serum levels of specific cytokines before and after treatment with ANB020
- Describe Limited Pharmacokinetics [ Time Frame: through study completion, an average of 60 days ]Peak Plasma Concentration (Cmax)
- Describe Limited Pharmacokinetics [ Time Frame: through study completion, an average of 60 days ]Time to maximum plasma concentration (Tmax)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male and female patients with age >18 years and able to give informed consent.
- Patients with a confirmed clinically allergic response to peanut.
- Positive clinical reaction during the peanut oral food challenge and no clinical reaction during the placebo challenge
- Positive peanut allergy skin prick test >3 mm of the negative control and detectable serum peanut-specific Immunoglobulin E (IgE) levels by ImmunoCAP testing.
- Body mass index (BMI) of 18 to 36 kg/m2 (inclusive) and total body weight >50 kg (110 lb). BMI = weight (kg)/(height [m2]).
- Willing and able to comply with the study protocol requirements.
- Have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the Investigator and staff.
- Women of childbearing potential, must have a negative serum pregnancy test at screening and Day 1, and be surgically sterile or using an acceptable method of contraception throughout the study and for 15 weeks after the last administration of investigational product. Postmenopausal patients defined as (1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 IU/L or (2) aged over 50 years with at least 1 year of amenorrhea.
- Male patients must be willing to use effective methods of contraception during the entire study period and for 15 weeks after the last administration of investigational product.
- Have concomitant dermatological or medical condition(s) which may interfere with the Investigator's ability to evaluate the patient's response to the investigational product.
- Have experienced severe life-threatening anaphylactic reactions to peanuts within 6 months before screening (i.e., requiring an intensive care unit (ICU) admission).
- Positive clinical reaction observed during the placebo oral food challenge.
- Participation in any interventional study for the treatment of peanut and/or food allergies in the 12 months before screening.
- Have received any investigational product or been part of any interventional clinical study within a period of 3 months or 5 half-lives (whichever is longer) before screening.
- Have received systemic corticosteroids, nonsteroidal, immunosuppressant, or immunomodulating drugs treatments within 2 weeks before screening.
- Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers within 2 weeks before screening.
- History of ischemic cardiovascular diseases.
- Use of biologics within 6 months before screening or subject is in build-up phase of allergen immunotherapy (excluding peanut) and has not reached maintenance dose.
- Have received antibiotic treatment within 1 week before screening.
- Have a history of hypersensitivity or allergic reactions following infusions of human blood or blood components.
- Have a history of hypersensitivity or allergic reactions a component of ANB020 formulation or the inactive ingredients (excipients).
- If female, are pregnant or lactating, or intend to become pregnant during the study period.
- Current diagnosis of asthma requiring Global Initiative for Asthma Assessment (GINA) Step 4 or higher treatment or asthma partially controlled or uncontrolled according to GINA classifications in the last three months before screening.
- History of a life threatening asthma attack within 1 year before screening (example: requiring an intensive care unit admission, intubation with mechanical ventilation).
- Other significant medical conditions that in the opinion of the Principal Investigator, prevent participation in the study.
- History of drug, alcohol or other substance abuse, or other factors limiting the ability to cooperate and to comply with the study protocol.
- Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
- Receipt of a live attenuated vaccine within 4 weeks before screening.
- Planned surgery during the study or 30 days before screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920021
|United States, California|
|Stanford Univ. Medical Center|
|Palo Alto, California, United States, 94305|
|United States, Washington|
|Asthma, Inc Clinical Research Center|
|Seattle, Washington, United States, 98115|
|Study Director:||Marco Londei, MD||AnaptysBio, Inc.|
|Responsible Party:||AnaptysBio, Inc.|
|Other Study ID Numbers:||
|First Posted:||September 30, 2016 Key Record Dates|
|Last Update Posted:||June 26, 2018|
|Last Verified:||June 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Immune System Diseases
Nut and Peanut Hypersensitivity