Testing RPT904 against a placebo for ig-e mediated food allergy
Official title: Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
- Phase 2
- 3 groups
- Sites in Vancouver, Burlington and 3 more cities
- Recruiting
Interventions (6)
- Medication
RPT904
Subcutaneous injection once every 8 weeks
- Medication
RPT904
Subcutaneous injection once every 12 weeks
- Other intervention
Placebo
Subcutaneous injection at the intervening dosing visits
- Medication
RPT904
Subcutaneous injection once every 8 weeks (Part 2)
- Medication
RPT904
Subcutaneous injection once every 12 weeks (Part 2)
- Other intervention
Placebo
Subcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2)
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia
- Recruiting
Halton Pediatric Allergy
Burlington, Ontario
- Recruiting
Ottawa Allergy Research Corporation
Ottawa, Ontario
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
- Recruiting
CHU Sainte-Justine
Montreal, Quebec
- Recruiting
McGill Unviversity
Montreal, Quebec
Eligibility Criteria
See who this study is looking for49 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria:
- +i. Allergic to peanut: participant must meet all criteria below:
- +ii. Allergic to milk or egg: unable to tolerate both cooked and uncooked forms:
- +iii. Allergic to cashew: participant must meet all criteria below:
- +iv. Allergic to walnut: participant must meet all criteria below:
- +i. Allergic to peanut or cashew: participant must meet all of the following criteria:
- +ii. Allergic to milk or egg: participant must meet all of the following criteria:
- +iii. Allergic to walnut: participant must meet all of the following criteria:
- +3\. Women of childbearing potential must have a negative pregnancy test before starting study treatment, agree to use a protocolProtocolThe detailed plan a study must follow.Read more →-defined method of contraception during the study and for at least 16 months after the last dose, and must not donate eggs or undergo egg retrieval during this period.
- +Participant and/or parent/legal guardian must be able to understand and provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and/or assent, as applicable.
- +Male or female, 12 to less than 56 years of age at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +a. For participants aged 12 to \<18 years:
- +1\. Positive SPT (≥4 mm wheal greater than saline controlControl groupThe group a new treatment is measured against.Read more →) to peanut.
- +2\. Positive peanut IgE (≥6 kUA/L) at screening or within 3 months of screening.
- +3\. Positive blinded oral food challenge (OFC) to peanut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut protein.
- +1\. Positive SPT (≥4 mm wheal greater than saline control) to the specific food.
- +2\. Positive food-specific IgE (≥6 kUA/L) at screening or within 3 months of screening.
- +3\. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein.
- +1\. Positive SPT (≥4 mm wheal greater than saline control) to cashew. OR
- +2\. Positive cashew IgE (≥6 kUA/L) at screening or within 3 months of screening. AND
- +3\. Positive blinded OFC to cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of cashew protein.
- +1\. Positive SPT (≥4 mm wheal greater than saline control) to walnut. OR
- +2\. Positive walnut IgE (≥6 kUA/L) at screening or within 3 months of screening AND
- +3\. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of walnut protein.
- +b. For participants aged 18 to \<56 years:
- +1\. Positive SPT (≥3 mm wheal greater than saline control) to peanut or cashew.
- +2\. Positive peanut or cashew IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- +3\. Positive blinded OFC to peanut or cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut or cashew protein.
- +1\. Positive SPT (≥3 mm wheal greater than saline control) to the specific food.
- +2\. Positive food-specific IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- +3\. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein.
- +1\. Positive SPT (≥3 mm wheal greater than saline control) to walnut.
- +2\. Positive walnut IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- +3\. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie cumulative dose of ≤444 mg) of walnut protein.
- +With body weight (as measured at screening) and total serum IgE level (as measured within 3 months of screening) suitable for RPT904 dosing (per RPT904 dosing table).
- +Female Participants:
- +Male Participants:
- +1\. Must not be pregnant or breastfeeding.
- +2\. Women of non-childbearing potential (e.g., surgically sterile or postmenopausal) are eligible.
- +1\. Must agree to either remain abstinent from heterosexual intercourse (if that is their usual lifestyle) or use protocol-defined contraception during the study and for 16 months after the last dose.
- +2\. Must not donate semen or participate in sperm banking during this time, and if they have a female partner of childbearing potential, she should also use effective contraception.
Exclusion
- −Sensitivity or suspected/known allergy to any component of the active or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → OFC material (excluding the test allergens peanut, milk, egg, walnut, and cashew being tested), or drugs related to RPT904 (eg, monoclonal antibodies, polyclonal gamma globulin).
- −Past or current medical problems (eg, severe latex allergy), chronic diseases (other than asthma/wheezing, atopic dermatitis, or rhinitis) requiring therapy (eg, heart disease, diabetes), abnormal physical findings or lab results not listed above that, in the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, may increase study related risks, hinder protocolProtocolThe detailed plan a study must follow.Read more → compliance, or impact data quality or interpretation .
- −Clinically significant lab abnormalities at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Uncontrolled or severe asthma/wheezing at screening.
- −Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- −Treatment with immunomodulatory therapy within 6 months of screening.
- −Past or current immunotherapy to any study foods within 6 months of screening.
- −Currently in the "build-up phase" of inhalant allergen immunotherapy (i.e., not yet on maintenance). Note: individuals on stable maintenance dosing may be eligible.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive RPT904, together with one or more of: PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: A: RPT904 (Q8W) · B: RPT904 (Q12W)
Group C, the placebo group, receives Placebo, together with one or more of: RPT904.
Registry label: C: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 55 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: Approximately 24 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — measured over Approximately 24 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07220811 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RPT904Drug
Subcutaneous injection once every 8 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RPT904Drug
Subcutaneous injection once every 12 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Subcutaneous injection at the intervening dosing visits
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About RPT904Drug
Subcutaneous injection once every 8 weeks (Part 2)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RPT904Drug
Subcutaneous injection once every 12 weeks (Part 2)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Subcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 55 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 24 weeks.
The study as a whole is currently expected to finish around 2028-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Vancouver, British Columbia, Canada; Burlington, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. RPT904 is a long-acting antibody that may allow for dosing every 8 to 12 weeks. Approximately 100 participants between the ages of 12 and 55 with documented allergy to at least one of the following foods: peanut, milk, egg, cashew, or walnut will be enrolled. In Part 1 (24 weeks), participants will be randomly assigned to receive RPT904 every 8 or 12 weeks (plus a loading dose at Week 2), or placebo. In Part 2 (24 weeks), participants who received RPT904 will continue on their assigned dosing schedule, and those who previously received placebo will be re-randomized to receive RPT904 either every 8 or 12 weeks (plus a loading dose at Week 26). All participants will attend study visits approximately every 2-6 weeks throughout both Part 1 and Part 2 to maintain blinding, regardless of treatment group or dosing frequency. The study is being conducted at multiple sites. The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic symptoms during a food challenge. The study will also monitor the safety and side effects of RPT904 over time. Each participant is expected to be in the study for about 68 to 74 weeks, including screening, treatment, and follow-up.
Other Sites (4)
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States
Northwell Health
Great Neck, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.