Is NCT07015996 recruiting in Little Rock, AR?

Yes, NCT07015996 is currently recruiting participants at its Little Rock, AR location. This peanut allergy clinical trial is actively enrolling qualified participants.

How do I join the peanut allergy clinical trial in Little Rock?

To join this clinical trial in Little Rock, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Little Rock clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Peanut Allergy Clinical Trial in Little Rock, AR

About This Peanut Allergy Study in Little Rock

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 maintain

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion 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 efficacy data of the study

Exclusion Criteria

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 the last 6 months, or current Asthma Control Test score less than 19 at screening

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 ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study

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 investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study

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 least 12 months prior to screening

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 Release Assay (IGRA), an IGRA may be repeated.

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 that may impact the quality or interpretation of the data obtained from the study

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 that may impact the quality or interpretation of the data obtained from the study

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 study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Little Rock?

Yes, this clinical trial (NCT07015996) has an active research site in Little Rock, AR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Peanut Allergy Treatment Options in Little Rock, AR

If you're searching for peanut allergy treatment options in Little Rock, AR, this clinical trial (NCT07015996) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Little Rock research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced peanut allergy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all peanut allergy clinical trials near you to find additional studies recruiting in your area.

Peanut Allergy Clinical Trial in Little Rock, AR

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