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Tests treatment safety and results for Peanut Allergy
Official title Efficacy of Tezepelumab in Peanut Oral Immunotherapy
ClinicalTrials.gov ID: NCT07015996
What this study is testing
What is Tezepelumab?
Tezepelumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for peanut allergy.
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
- The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a monotherapy period comprised of injections of either Tezepelumab or placebo from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 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 (parental permission and informed assent of minor...
- Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion
- A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC
- A negative challenge to the placebo (oat) during the Screening DBPCFC
- Sensitization to peanut as evidenced by either one of the following:
You likely can't join if
- Currently in build-up phase of aeroallergen immunotherapy
- Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months
- Pregnant, planning a pregnancy during the study, or breast-feeding
- History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG...
- Allergy to oat (participant reported)
- History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension...
See the full eligibility criteria
- Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable).
- Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion
- A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC
- A negative challenge to the placebo (oat) during the Screening DBPCFC
- Sensitization to peanut as evidenced by either one of the following:
- positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, or
- wheal ≥ 3 mm on skin prick test to peanut extract compared to a negative control
- Female participants of childbearing potential must have a negative pregnancy test upon study entry
- Female participants with reproductive potential must agree to use an FDA approved method of contraception for the duration of the study
- Willing and able to comply with the study protocol requirements
- Participants with other food allergies must agree to continue avoidance of these food items from their diet to avoid confounding the safety and how well it works data of the study
- Currently in build-up phase of aeroallergen immunotherapy
- Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months
- Pregnant, planning a pregnancy during the study, or breast-feeding
- History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG biologics, or rescue medications and their excipients
- Allergy to oat (participant reported)
- History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension requiring intensive care unit admission
- Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents)
- History of a life-threatening asthma attack within 12 months prior to screening (e.g., requiring an ICU admission or intubation with mechanical ventilation), need for oral corticosteroids for asthma management within...
- History of ischemic cardiovascular disease or other cardiac disease, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's...
- History of eosinophilic gastrointestinal disease at screening
- History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, which, in the opinion of the site...
- History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at...
- Current known helminth infection
- Positive QuantiFERON - TB Gold test or TB Gold Plus, or T-SPOT® TB test unless the potential participant has been treated with appropriate chemoprophylaxis. In the case of an indeterminate or borderline Interferon Gamma...
- Any of the following:
- Current or prior infection with hepatitis B virus (HBV)
- Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.
- Active liver disease, defined as either:
- AST, ALT, and/or Alk phos \>2x ULN, or
- other active liver disease which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or...
- Any of the following:
- Current use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
- Received any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
- Received systemic corticosteroids within 14 days prior to screening
- Receipt of immunoglobulin or other blood product within 30 days prior to screening
- Receipt of live attenuated vaccine within 30 days prior to screening
- Use of an immunosuppressant or immunomodulating drug within 30 days prior to screening
- Use of biologics targeting the human immune system within the past 12 months prior to screening
- Use of any herbal medications, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or...
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Little Rock, Arkansas, United States; Los Angeles, California, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.