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New treatment option for Ig-E Mediated Food Allergy
Official title Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
ClinicalTrials.gov ID: NCT07220811
What this study is testing
What is RPT904?
RPT904 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ig-e mediated food allergy.
Also referred to as ozureprubart, JYB1904.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 55
You may be able to join if
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 12 to less than 56 years of age at screening.
- Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria:
- a. For participants aged 12 to \<18 years:
- i. Allergic to peanut: participant must meet all criteria below:
You likely can't join if
- Clinically significant lab abnormalities at screening.
- Sensitivity or suspected/known allergy to any component of the active or placebo OFC material (excluding the test allergens peanut, milk, egg...
- Uncontrolled or severe asthma/wheezing at screening.
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- Past or current immunotherapy to any study foods within 6 months of screening.
- Treatment with immunomodulatory therapy within 6 months of screening.
See the full eligibility criteria
Who can join
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 12 to less than 56 years of age at screening.
- Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria:
- a. For participants aged 12 to \<18 years:
- i. Allergic to peanut: participant must meet all criteria below:
- 1\. Positive SPT (≥4 mm wheal greater than saline control) 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.
- ii. Allergic to milk or egg: unable to tolerate both cooked and uncooked forms:
- 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.
- iii. Allergic to cashew: participant must meet all criteria below:
- 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.
- iv. Allergic to walnut: participant must meet all criteria below:
- 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:
- i. Allergic to peanut or cashew: participant must meet all of the following criteria:
- 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.
- ii. Allergic to milk or egg: participant must meet all of the following criteria:
- 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.
- iii. Allergic to walnut: participant must meet all of the following criteria:
- 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:
- 1\. Must not be pregnant or breastfeeding.
- 2\. Women of non-childbearing potential (e.g., surgically sterile or postmenopausal) are eligible.
- 3\. Women of childbearing potential must have a negative pregnancy test before starting study treatment, agree to use a protocol-defined method of contraception during the study and for at least 16 months after the last...
- Male Participants:
- 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.
What rules you out
- Clinically significant lab abnormalities at screening.
- Sensitivity or suspected/known allergy to any component of the active or placebo OFC material (excluding the test allergens peanut, milk, egg, walnut, and cashew being tested), or drugs related to RPT904 (eg, monoclonal...
- Uncontrolled or severe asthma/wheezing at screening.
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- Past or current immunotherapy to any study foods within 6 months of screening.
- Treatment with immunomodulatory therapy 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Great Neck, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Colorado Springs, Colorado, United States; Denver, Colorado, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.