StudyFinder
Search Results Within Category "Allergy"
6 Study Matches
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
- yasmin.hassoun@cchmc.org
ALL
4 years and over
PHASE4
NCT06834165
Inclusion Criteria:
* Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
* Has body weight 15 kg or greater at the time of allergy challenge.
* Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
* Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.
Exclusion Criteria:
\- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator. DRUG: Neffy, DRUG: Adrenaline
Allergic Reactions
Study of Oral Food Challenge Biomarkers (SAFER) (SAFER)
Glenda Knox - glenda.knox@cchmc.org
ALL
12 months to 17 years old
NCT07279467
Inclusion Criteria:
• Parent or guardian must be able to understand and provide written informed consent and participant must be able to understand and provide assent (if applicable)
• Are 12 months - 17 years of age during Screening.
• Are sensitized to peanut, as demonstrated by one of the following: a. A participant-reported reaction to peanut (at any time) deemed by the investigator to be consistent with an IgE-mediated reaction and one of the following within the past 12 months i. Positive Skin Prick Test (SPT) to peanut (wheal diameter that is ≥ 3mm larger than saline control) ii. Positive peanut-specific IgE (sIgE; ≥ 0.10 kUA/L) determined by ImmunoCap b. An Ara h 2 sIgE ≥ 1.0 kUA/L, measured within the past 12 months
• Are currently avoiding peanut
Exclusion Criteria:
• Are pregnant
• Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy
• Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation
• Have received treatment with dupilumab/Dupixent® within the prior 2 years, OR treatment with omalizumab/Xolair®, other biologics, or systemic immunomodulatory agents within the prior year
• Inability to comply with the required aspects of the study protocol
• Have past or current medical conditions or findings from the physical examination, not already listed, that, in the judgment of the site investigator, may pose additional risks related to participation in the study, interfere with the participant's ability to comply with study requirements, or impact the quality or interpretation of the study data
• Have been treated with oral steroid or beta blockers within 14 days of the Oral Food Challenge (OFC)
• Are unable to discontinue medications, as specified in the Protocol CoFAR-15 MOP, for the minimum wash-out periods prior to Skin Prick Test (SPT) or OFC
• Have poorly controlled atopic dermatitis (AD) at Screening, per the PI's discretion
• Have poorly controlled or severe asthma/wheezing at Screening, as defined as experiencing or including any of the following:
• Meeting the Global Initiative for Asthma (GINA) criteria for uncontrolled asthma
• History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing;
• Prior intubation/mechanical ventilation for asthma/wheezing;
• One hospitalization or ED visit for asthma/wheezing within six months of Screening;
• Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75% of predicted, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry);
• Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables MOP)
• Refuse blood sample collection during Screening
• The SPT performed during Screening is negative to peanut allergen without dilution (wheal diameter that is \< 3mm larger than saline control).
DRUG: Oral Food Challenge (OFC): Peanut Protein
Allergy
Food Allergy, Peanut Allergy, Oral Food Challenge, CoFAR-15, SAFER, Biomarkers
Efficacy of Tezepelumab in Peanut Oral Immunotherapy (ZENITH)
Glenda Knox - glenda.knox@cchmc.org
ALL
12 years to 55 years old
PHASE2
NCT07015996
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:
• HIV
• 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
BIOLOGICAL: Tezepelumab, DRUG: Peanut Oral Immunotherapy (OIT), BIOLOGICAL: Placebo for Tezepelumab
Peanut Allergy
Tezepelumab, Peanut, Oral Immunotherapy
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
Bliss Magella - bliss.magella@cchmc.org
ALL
NCT00267501
Inclusion Criteria:
* Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
* Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease, Food Allergy
Eosinophilic Disorders
Infant Formula in Infants and Children With Cow's Milk Allergy
Jennifer Jennings - jennifer.jennings2@cchmc.org
ALL
3 months to 12 years old
NA
NCT06456541
Inclusion Criteria:
* Participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
• Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \>0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
• Documentation of milk-specific serum IgE ≥15 kUᴀ/L or ≥ 5 kUᴀ/L if younger than 1 year;
• Documented cow's milk skin prick test wheal ≥8mm;
• Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms. * Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges. * Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment. * Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study. * Participant is between 3 months and 12 years of age at enrollment. * Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion Criteria:
* Participant is partially or exclusively breastfed at the time of enrollment.
* Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula.
* Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than CMA, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
* Previous severe anaphylactic reaction to cow's milk within the last two years.,
* An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test.
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent.
* Participant is consuming baked milk products.
* Use of and/or changing dose of high potency steroids.
* Participant is treated with any oral immunotherapy (sublingual, subcutaneous, and epicutaneous) for any food allergy. OTHER: Experimental Extensively Hydrolyzed Formula, OTHER: Placebo Extensively Hydrolyzed Formula
Cow's Milk Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Constance Harpring - constance.harpring@cchmc.org
ALL
12 years to 55 years old
PHASE2
NCT07220811
Key
Inclusion Criteria:
* 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 dose, and must not donate eggs or undergo egg retrieval during this period.
* 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.
Exclusion Criteria:
* 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 antibodies, polyclonal gamma globulin).
* 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 lab results not listed above that, in the Principal Investigator's opinion, may increase study related risks, hinder protocol compliance, or impact data quality or interpretation . DRUG: RPT904, DRUG: RPT904, OTHER: Placebo, DRUG: RPT904, DRUG: RPT904, OTHER: Placebo
Ig-E Mediated Food Allergy
Ig-E Mediated food allergy, peanut allergy, milk allergy, egg allergy, cashew allergy, walnut allergy, RPT904, placebo, double-blind placebo-controlled food challenge (DBPCFC), ozureprubart, JYB1904