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Clinical trial developed at various hospitals where each patient randomly receive in parallel groups either placebo or treatment. Nor patients or investigators will know what the patient it's being given. This clinical trial evaluates efficacy and safety of the immunotherapy with allergen "Cup a 1" (major protein in Cupressus arizónica) in patients with allergic rhinoconjunctivitis with or without asthma sensitized to Cupressaceae pollen
EU CTIS ID: 2024-519527-14-00
What this study is testing
Assessment of efficacy of specific immunotherapy with the purified and isolated protein Cup a 1 administered subcutaneously in patients sensitized to the allergen under study
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female from 12 to 65 years of age included
- Obtaining informed consent to participate in the study, as well as legal guardians or legal representatives, if it is a minor
- Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without asthma controlled by demonstrated sensitization to Cupresaceae
- Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6)
- Positive skin prick test (≥3 mm in diameter) for Diater extract of Cupressaceae arizónica and Cup a 1, carried out in V0
- Clinically relevant symptoms against cupresaceae.
You likely can't join if
- Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion
- Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests
- Psychiatric disorder that prevents adequate compliance with the immunotherapy program
- Pregnant or lactating woman
- Simultaneous participation in another clinical trial
- Any disease that interferes with the absorption or elimination of the investigational products
See the full eligibility criteria
- Male or female from 12 to 65 years of age included
- Obtaining informed consent to participate in the study, as well as legal guardians or legal representatives, if it is a minor
- Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without asthma controlled by demonstrated sensitization to Cupresaceae
- Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6)
- Positive skin prick test (≥3 mm in diameter) for Diater extract of Cupressaceae arizónica and Cup a 1, carried out in V0
- Clinically relevant symptoms against cupresaceae.
- Willingness to comply with all protocol requirements and availability for follow-up throughout the duration of the trial
- Negative urine pregnancy test for women of childbearing potential (fertile from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and willing to use effective contraception from 14 days before the first administration until 30 days after the last investigational product administration.
- Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion
- Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests
- Psychiatric disorder that prevents adequate compliance with the immunotherapy program
- Pregnant or lactating woman
- Simultaneous participation in another clinical trial
- Any disease that interferes with the absorption or elimination of the investigational products
- Chronic abuse of alcohol or any other type of substance that, in the opinion of the investigator, may interfere with the trial
- Nasal or paranasal recent or scheduled pathology or surgery that may interfere with the trial, such as polyposis, at the investigator's discretion
- Uncontrolled serious systemic diseases, such as autoimmune, cardiovascular, hyperthyroidism, liver disease or kidney failure, malignant tumours or chronic infection
- Uncontrolled asthma despite optimal pharmacological treatment
- Having received immunotherapy to cupresaceae or phylogenetically related allergens in the 5 years prior to the start of the trial
- Being receiving immunotherapy against other different allergens than Cupressaceae concomitantly during the trial
- Adrenaline use contraindication
- Active tuberculosis
- Severe atopic eczema
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.