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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | 24 week treatment of IV abatacept following recommended dosages from the monograph |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peanut specific/total IgE at week 24 | Relative change in peanut specific/total IgE from baseline to week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peanut-specific IgG4/IgE ratio at week 24 | Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24 | 24 weeks |
| Peanut-specific IgG4 at week 24 | Absolute change in peanut-specific IgG4 from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Atopy patch test | Change in peanut atopy patch test from baseline | week 12, week 24 and week 48 |
| Skin test | Change in peanut skin test from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Montreal | Quebec | H3T1C5 | Canada |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Placebo | Drug | 24 week treatment of IV placebo following recommended dosages from the abatacept monograph |
|
| Peanut oral immunotherapy | Other | Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo. |
|
| 24 weeks |
| Sustained tolerance | Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated | Assessed between week 36 and week 48 |
| Food dosing reactions | Mean cumulative function of food dosing allergic reactions | 48 weeks |
| Desensitization | Highest tolerated dose on an oral food challenge at week 36 | 36 weeks |
| Desensitization speed | Time from the onset of oral immunotherapy to the maintenance dose of 300mg | 36 weeks |
| Adverse events | Overall rate of adverse events | 48 weeks |
| week 12, week 24 and week 48 |
| Peanut specific/total IgE, other time points | Relative change in peanut specific/total IgE from baseline | weeks 2, 6, 12, 36 and 48 |
| Peanut-specific IgG4/IgE ratio, other time points | Relative change in peanut-specific IgG4/IgE ratio from baseline | weeks 2, 6, 12, 36 and 48 |
| Peanut-specific IgG4, other time points | Absolute change from baseline in peanut-specific IgG4 | weeks 2, 6, 12, 36 and 48 |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |