Is NCT07117669 recruiting in Aurora, CO?

Yes, NCT07117669 is currently recruiting participants at its Aurora, CO location. This peanut allergy clinical trial is actively enrolling qualified participants.

How do I join the peanut allergy clinical trial in Aurora?

To join this clinical trial in Aurora, 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 Aurora 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 Aurora, CO

Who Can Participate

Inclusion Criteria

14-50 years of age (inclusive)

Otherwise medically healthy and able to participate in the study

Able to perform spirometry testing in accordance with the American Thoracic Society (ATS) guidelines (2019)

All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product

Signed and dated written informed consent from the participant and/or parent or guardian

Signed and dated assent from participant under 18 in accordance with local IRB regulations

Willing and able to avoid peanut and peanut contaminants for the duration of the trial Part 1 Cohort 1 only (NPA Participants)

No known clinical history of peanut allergy with regular exposure to peanuts in daily life, i.e ingests peanuts without symptoms

Negative Skin Prick Test (SPT) (wheal diameter of \<3 mm) to peanut Part 1 Cohort 2 only (PA Participants)

A documented clinical history of peanut allergy, which includes the development of symptoms (e.g., urticaria, flushing, rhinorrhea and sneezing, throat tightness or hoarseness, wheezing, vomiting) verified by a physician

At least two of the three following requirements:

Positive Skin Prick Test (SPT) (wheal diameter of ≥ 8 mm) to peanut

An elevated serum peanut specific IgE level ≥ 7 kUA/L (ImmunoCAP®)

An Ara-h2 IgE level of ≥ 2 kUA/L (ImmunoCAP®) Part 2:

14 to 50 years of age (inclusive)

At least two of the three following requirements at screening:

Positive SPT (wheal diameter of ≥ 3 mm) to peanut

Serum peanut-specific IgE level ≥ 0.7 kUA/L (ImmunoCAP®)

An Ara-h2 IgE level of ≥ 0.5 kUA/L (ImmunoCAP®) within 1 year of enrollment

Participant must be willing and able to complete a DBPCFC at screening and EOT (24-hours after last dose) and experience dose-limiting symptoms at or before the 300 mg challenge dose of peanut protein during a Double Blind, Placebo Controlled Food Challenge (DBPCFC) conducted in accordance with Practical Issues in Allergology, Joint United States/European Union Initiative (PRACTALL) guidelines

Otherwise medically healthy and able to participate in the study

Able to perform spirometry testing in accordance with the ATS guidelines (2019)

Signed and dated written informed consent from the participant and/or parent or guardian

Signed and dated assent from participant under 18 in accordance with local IRB regulations

Willing and able to avoid peanut and peanut contaminants for the duration of the trial

Exclusion Criteria

History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs

Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF \>/= 450 msec at Screening

FEV1 value \< 80% predicted at Screening

Any hospitalization in the past year for asthma, \>1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma

Poorly controlled atopic dermatitis

Eosinophilic gastrointestinal disease

Use of oral or IV corticosteroids within 30 days of Screening

Use of tricyclic antidepressants within 6 months of Screening

Inability to discontinue antihistamines for at least 5 half-lives before skin testing

Use of omalizumab or other immunomodulatory therapy (not including corticosteroids) or biologic therapy within one year of Screening

Use of any food allergen-specific or other non-traditional form of allergen immunotherapy within one year of Screening

Use of immunosuppressive drugs within 30 days of Screening

Use of ß-blockers (oral)

Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis

Pregnant or breast-feeding (if female)

Behavioral, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the participant to understand and cooperate with the study protocol

Known allergy to inactive ingredients of investigational product (active or placebo)

Participation in another interventional clinical trial within 30 days of Screening or within 5 half-lives of the other IP

Residing at the same address as another participant in this or any peanut immunotherapy 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 Aurora?

Yes, this clinical trial (NCT07117669) has an active research site in Aurora, CO 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 Aurora, CO

If you're searching for peanut allergy treatment options in Aurora, CO, this clinical trial (NCT07117669) 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 Aurora research site is actively enrolling participants for this 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 Aurora, CO

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About This Peanut Allergy Study in Aurora