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New treatment option for Allergy
Official title LYmph Node eXamination in Cat Allergen Immunotherapy
ClinicalTrials.gov ID: NCT07447869
What this study is testing
What is Intradermal cat allergen challenge?
Intradermal cat allergen challenge is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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
- Sixteen eligible cat-allergic participants will be accrued in the study. Eight participants who have been on subcutaneous immunotherapy (SCIT) at maintenance dosing for at least 1 year will be assigned to the SCIT cohort, and 8 participants who have never been on cat immunotherapy will be assigned to the No immunotherapy (IT) cohort.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Participant must be able to understand and provide informed consent
- A clinical history of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure, such that exposure is currently, or was historically to...
- Skin prick test wheal greater than or equal to 5 mm to standardized cat extract or cat-specific IgE greater than or equal to 0.7 kU/L obtained within...
- Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
- For participants in the Subcutaneous Immunotherapy (SCIT) cohort, the following inclusion criterion applies as well: A history of at least 1 year of...
You likely can't join if
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Current household exposure to cat or regular occupational exposure to cat
- For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
- For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
- A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
- Partially controlled or uncontrolled asthma as per Global Initiative for Asthma (GINA) guidelines in the 4 weeks prior to screening. Participants may...
See the full eligibility criteria
- Participant must be able to understand and provide informed consent
- A clinical history of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure, such that exposure is currently, or was historically to the initiation of treatment, interfering with usual daily activities...
- Skin prick test wheal greater than or equal to 5 mm to standardized cat extract or cat-specific IgE greater than or equal to 0.7 kU/L obtained within 5 years of screening. These can be obtained from medical records if...
- Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
- For participants in the Subcutaneous Immunotherapy (SCIT) cohort, the following inclusion criterion applies as well: A history of at least 1 year of maintenance subcutaneous allergen immunotherapy to cat, with currently...
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Current household exposure to cat or regular occupational exposure to cat
- For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
- For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
- A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
- Partially controlled or uncontrolled asthma as per Global Initiative for Asthma (GINA) guidelines in the 4 weeks prior to screening. Participants may be rescreened once asthma is well-controlled
- Severe asthma as defined by GINA guidelines in the previous 12 months
- History of emergency visit or hospital admission for asthma in the previous 12 months
- History of chronic obstructive pulmonary disease
- History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment
- History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure...
- 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...
- Any of the following:
- Inhaled tobacco, vaping, or use of inhaled illicit substances within 6 weeks of screening
- Receipt of any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
- Receipt of systemic corticosteroids within 14 days prior to screening
- Receipt of immunoglobulin within 5 months of screening
- Receipt of other blood product within 30 days of screening
- Use of an immunosuppressant or other immunomodulating drug, except for systemic corticosteroids, within 30 days prior to screening
- Use of biologics targeting the human immune system within the past 24 months prior to screening
- Receipt of any vaccination within the past 6 weeks prior to screening
- Pregnant, planning a pregnancy during the study, or breast-feeding
- Bleeding disorders
- BMI \>= 40
- Other anatomic or musculoskeletal abnormalities that would interfere with FNA sampling procedure
- History of lymphedema
- 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
- Boston, Massachusetts, 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, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.