ATARI: Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

• Sponsor: Philippe Bégin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04872218
• Collaborator: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Enrollment: 14
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peanut Allergy	Drug: Abatacept; Drug: Placebo; Other: Peanut oral immunotherapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind Randomized Controlled Trial of 6-month of Abatacept vs Placebo as Adjuvant to Peanut Oral Immunotherapy to Induce Immunologic Changes in Patients With Severe Persistent Peanut Allergy
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abatacept	Drug: Abatacept; 24 week treatment of IV abatacept following recommended dosages from the 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.
Placebo Comparator: Placebo	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.

Outcome Measures

Primary Outcome Measures

1. Peanut specific/total IgE at week 24 [24 weeks]

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

Secondary Outcome Measures

1. Peanut-specific IgG4/IgE ratio at week 24 [24 weeks]

   Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24

2. Peanut-specific IgG4 at week 24 [24 weeks]

   Absolute change in peanut-specific IgG4 from baseline to week 24

3. Sustained tolerance [Assessed between week 36 and week 48]

   Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated

4. Food dosing reactions [48 weeks]

   Mean cumulative function of food dosing allergic reactions

5. Desensitization [36 weeks]

   Highest tolerated dose on an oral food challenge at week 36

6. Desensitization speed [36 weeks]

   Time from the onset of oral immunotherapy to the maintenance dose of 300mg

7. Adverse events [48 weeks]

   Overall rate of adverse events

Other Outcome Measures

1. Atopy patch test [week 12, week 24 and week 48]

   Change in peanut atopy patch test from baseline

2. Skin test [week 12, week 24 and week 48]

   Change in peanut skin test from baseline

3. Peanut specific/total IgE, other time points [weeks 2, 6, 12, 36 and 48]

   Relative change in peanut specific/total IgE from baseline

4. Peanut-specific IgG4/IgE ratio, other time points [weeks 2, 6, 12, 36 and 48]

   Relative change in peanut-specific IgG4/IgE ratio from baseline

5. Peanut-specific IgG4, other time points [weeks 2, 6, 12, 36 and 48]

   Absolute change from baseline in peanut-specific IgG4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Sainte-Justine	Montréal	Quebec	Canada	H3T1C5

Sponsors and Collaborators

• Philippe Bégin
• Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philippe Bégin, Associate professor, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT04872218
• Other Study ID Numbers: CITO-2021-01
• First Posted: May 4, 2021
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Philippe Bégin, Associate professor, St. Justine's Hospital: Peanut allergy; Abatacept; Oral immunotherapy
• Additional relevant MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Abatacept

Study Results

No Results Posted as of May 9, 2022