Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||14 Years - 50 Years|
- - Male or female subjects 14 to 50 years old at screening visit.
- - History of IgE mediated allergy to peanut protein.
- - ImmunoCAP IgE level > 50 kU/L for peanut; - Total IgE level < 5000 kU/L.
- - Willing to comply to all study requirements during participation in the study;
Exclusion Criteria:- Previous adverse reactions to abatacept; - Known hypersensitivity to abatacept or any of its components; - Patients at risk of sepsis, such as immunocompromised or HIV positive; - Patient undergoing a treatment with any other biologic agent; - Uncontrolled asthma; - Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease); - Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Placebo Comparator: Placebo
Drug: - Abatacept
24 week treatment of IV abatacept following recommended dosages from the monograph
Drug: - Placebo
24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Other: - Peanut oral immunotherapy
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.