Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

Study Purpose

This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy. This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission. Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	14 Years - 50 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

- Concurrent/prior use of immunomodulatory therapy (within 6 months); - A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis; - Pregnant or breastfeeding women;

Trial Details

Trial ID: 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.	NCT04872218
Phase 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.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Philippe Bégin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Arms & Interventions

Arms

Experimental: Abatacept

Placebo Comparator: Placebo

Interventions

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

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International Sites

CHU Sainte-Justine, Montréal, Quebec, Canada

Status

Address

CHU Sainte-Justine

Montréal, Quebec, H3T1C5

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