Peanut AllergyPhase 2ATARINCT04872218
Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
A Phase 2 study testing Abatacept and Peanut oral immunotherapy in people with Peanut Allergy, run by Philippe Bégin at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Abatacept and Peanut oral immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 4 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Abatacept, Placebo, Peanut oral immunotherapy
- Keywords
- Peanut allergy, Abatacept, Oral immunotherapy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
24 week treatment of IV abatacept following recommended dosages from the monograph
PlaceboDrug
24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Peanut oral immunotherapyOther
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Not described Receives: Drug: Abatacept; Other: Peanut oral immunotherapy |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Peanut oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peanut specific/total IgE at week 24
Relative change in peanut specific/total IgE from baseline to week 24
Measured: 24 weeks
Secondary outcomes (7)
Peanut-specific IgG4/IgE ratio at week 24
Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Measured: 24 weeks
Peanut-specific IgG4 at week 24
Absolute change in peanut-specific IgG4 from baseline to week 24
Measured: 24 weeks
Sustained tolerance
Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Measured: Assessed between week 36 and week 48
Food dosing reactions
Mean cumulative function of food dosing allergic reactions
Measured: 48 weeks
Desensitization
Highest tolerated dose on an oral food challenge at week 36
Measured: 36 weeks
Desensitization speed
Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Measured: 36 weeks
Adverse events
Overall rate of adverse events
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Mar 2022
- Primary completion10 May 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippe Bégin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Bégin, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872218
- Sponsor's protocol ID
- CITO-2021-01
- Acronym
- ATARI
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04872218
- Acronym / sponsor ID
- ATARI / CITO-2021-01
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergy, Abatacept, Oral immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Philippe BéginUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: Abatacept, Other: Peanut oral immunotherapy |
| Placebo | Placebo comparator | Drug: Placebo, Other: Peanut oral immunotherapy |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept24 week treatment of IV abatacept following recommended dosages from the monograph | Drug | Abatacept |
| Placebo24 week treatment of IV placebo following recommended dosages from the abatacept monograph | Drug | Placebo |
| Peanut oral immunotherapyPeanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo. | Other | Abatacept, Placebo |
Primary outcome
Peanut specific/total IgE at week 24
Time frame: 24 weeks
Relative change in peanut specific/total IgE from baseline to week 24
7 secondary outcomes
Peanut-specific IgG4/IgE ratio at week 24
Time frame: 24 weeks
Peanut-specific IgG4 at week 24
Time frame: 24 weeks
Sustained tolerance
Time frame: Assessed between week 36 and week 48
Food dosing reactions
Time frame: 48 weeks
Desensitization
Time frame: 36 weeks
Desensitization speed
Time frame: 36 weeks
Adverse events
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept and Peanut oral immunotherapy in people with Peanut Allergy, run by Philippe Bégin at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peanut specific/total IgE at week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.