Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

NCT04872218 | Completed Phase 2

• 1 other identifier: CITO-2021-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

Peanut allergy; Abatacept; Oral immunotherapy

Outcome Measures

Primary Outcomes (1)

• Peanut specific/total IgE at week 24

  Relative change in peanut specific/total IgE from baseline to week 24

  24 weeks

Secondary Outcomes (7)

• Peanut-specific IgG4/IgE ratio at week 24

  24 weeks

• Peanut-specific IgG4 at week 24

  24 weeks

• Sustained tolerance

  Assessed between week 36 and week 48

• Food dosing reactions

  48 weeks

• Desensitization

  36 weeks

Other Outcomes (5)

• Atopy patch test

  week 12, week 24 and week 48

• Skin test

  week 12, week 24 and week 48

• Peanut specific/total IgE, other time points

  weeks 2, 6, 12, 36 and 48

Study Arms (2)

Abatacept

EXPERIMENTAL

Drug: Abatacept; Other: Peanut oral immunotherapy

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Other: Peanut oral immunotherapy

Interventions

Abatacept DRUG

24 week treatment of IV abatacept following recommended dosages from the monograph

Abatacept

Placebo DRUG

24 week treatment of IV placebo following recommended dosages from the abatacept monograph

Placebo

Peanut oral immunotherapy OTHER

Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.

Abatacept; Placebo

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Philippe Bégin: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: March 1, 2022
• Primary Completion: May 10, 2024
• Study Completion: November 4, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)