OPAL: Combining Peanut Oral Immunotherapy and Omalizumab in Adults with Peanut Allergy
Assessing the Utility of Combining Peanut Oral Immunotherapy and Omalizumab in Adults In Improving Tolerance of Peanut Protein with Peanut Allergy
St Vincent's Hospital Sydney
25 participants
Nov 18, 2020
Interventional
Conditions
Summary
This is a prospective, single-arm study of adults who react at blinded challenge to less than 300mg of peanut protein (approx. one peanut kernel) that will evaluate the utility of omalizumab as an adjunctive therapy to improve safety, as indicated by severity and frequency of reactions due to immunotherapy, and patient acceptability, as indicated by improved completion of the full course of oral immunotherapy, when compared to existing literature. Treatment in the study will consist of three phases. For the first phase, all participants will receive omalizumab injections every 4 weeks for 12 weeks. In the second 12 weeks, all participants will commence peanut oral immunotherapy and will continue omalizumab injections every 4 weeks. In the third phase, from week 24, omalizumab will cease and a maintenance dose of peanut will continue until the final study visit at 48 weeks. DBPCFC will be performed at screening, Week 24 and Week 48. Peanut protein doses of up to 100mg will be in the form of roast peanut fines or flour. Doses of 150mg and above will be taken in the form of whole roast peanut or smooth peanut butter according to patient preference. At Baseline, Week 12, Week 24 and Week 48 blood will be collected and tested for specific IgE, IgG4 and basophil activation tests to total peanut protein and protein components to assess for changes in peanut-specific immunity in response to trial interventions, and to evaluate the utility of such tests in predicting outcomes to therapy in adults
Eligibility
Inclusion Criteria5
- Age greater than or equal to 16 years
- History of immediate (Type 1) allergic reaction to peanut
- Positive response to less than 300mg of peanut protein at the screening double-blind, placebo-controlled oral peanut challenge
- Skin prick test to peanut reagent greater than 3mm with appropriate responses to positive and negative controls
- Willing and able to give written informed consent to participate in and comply with all aspects of the study
Exclusion Criteria10
- Anaphylaxis to peanut requiring intensive care unit admission in the previous 5 years
- Participants who react to placebo at double-blind, placebo-controlled challenge
- Women who are lactating, pregnant or of childbearing potential and not willing to avoid becoming pregnant during the study
- Severe or unstable asthma
- Unstable cardiac disease
- Ongoing treatment with a beta-blocker, angiotensin converting enzyme inhibitor, calcium channel blocker, angiotensin receptor blocker or non-steroidal anti-inflammatory drug
- Participants that cannot be safely taken off oral corticosteroid therapy for 7 days or antihistamines for 72 hours for the purposes of oral peanut challenge
- Prior peanut immunotherapy
- Omalizumab or mepolizumab in the previous 3 months
- Other medical condition that the investigator considers will unacceptably increase the risk of peanut oral challenge
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Interventions
Phase 1: Week 0 to 11 (inclusive)- Omalizumab only: Subcutaneous injection of 300mg omalizumab will occur on Weeks 0 (baseline), 4, 8, 12, 16 and 20. Injection will be administered by the study nurse into the upper arms of the participant, and all participants will be observed for a minimum of 30 minutes following administration of the dose. Phase 2: Week 12 to 24 (inclusive)- Omalizumab and Induction Immunotherapy: Oral immunotherapy will be administered from Week 12 through to Week 48. Weeks 12 to 24 is induction immunotherapy. Weeks 24 to 48 is maintenance immunotherapy. Immunotherapy will be initiated on Day 1 of Week 12. Day 1 will consist of multiple steps of building up to a dose of 25mg peanut protein (Rush Induction). Dosing will be administered in the form of roasted peanut fines or peanut flour. Rush induction will be performed in a clinical setting at the study site, and doses of peanut protein will be administered by the study nurse. If the participant tolerates all doses, they will be observed for a minimum of 2 hours prior to discharge and return on Day 2 for a single administration of 25mg of peanut protein under the same conditions as Day 1. If tolerated, participants will be given with individual packages of daily 25mg peanut protein doses to take at the home for the next fortnight. They will also be given an Immunotherapy Diary to be completed daily, marking the date and time the immunotherapy was taken, and any reactions experienced. At the end of this fortnight, participants will return to clinic to receive an increased dose of peanut protein. This dose of peanut protein will be administered by the study nurse. If tolerated the participant will be sent home with a 14-day supply of the new dose of immunotherapy. Doses will continue to be increased fortnightly as follows: Weeks 12-13: 25mg Weeks 14-15: 50mg Weeks 16-17: 100mg Weeks 18-19: 150mg Weeks 20 -21: 150mg (new peanut product) Weeks 22-23: 200mg At Week 20 there will be no increase in dose, but participants will be changed from peanut flour to their choice of either whole roasted peanut or smooth peanut butter of equivalent peanut content (e.g. ½ a peanut kernel or 0.3g peanut butter). The first dose will be supervised as per previous up-dosing, and if tolerated they will be required to take the same amount of that peanut product daily for 2 weeks. All subsequent immunotherapy will be given in this same form. Immunotherapy diaries will be checked at each of these study visits. Omalizumab will continue to be given every 4 weeks during this time, with the final dose of omalizumab given at Week 20 Phase 3: Week 24 to end of study (Week 48)- Maintenance Immunotherapy: Participants will be continued on a daily dose of 300mg peanut protein in the form of patient’s preference.
Locations(5)
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ACTRN12620001203943