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Study to evaluate the safety and efficacy of a treatment consisting of immunotherapy by subcutaneous injection of a combination of Der p 1/Der p 2/Der p 23 allergens at different doses in patients with allergic rhinitis or rhinoconjunctivitis with or without allergic asthma.
EU CTIS ID: 2024-518519-20-01
What this study is testing
To evaluate the benefit/risk balance of 3 of ITSC doses with the main allergens of D. pteronyssinus Der p 1/Der p 2/Der p 23 purified to find the optimal dose after having received 12 maintenance doses.
- Therapeutic exploratory (Phase II)
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
- Patients/legal representatives who have understood and signed the informed consent or assent form.
- Patients between 12 and 65 years of age, both inclusive.
- Patients with moderate or severe persistent allergic rhinitis and/or rhinoconjunctivitis (according to ARIA2 guidelines) for at least the last year, caused by clinically relevant sensitization to Dermatophagoides genus, fulfilling all the criteria described below: 3.a. Clinical history with symptoms compatible with demonstrated hypersensitivity to the genus Dermatophagoides. 3.b. Positive skin prick test (papule of ≥3 mm with respect to the negative control) against at least one of the following major allergens: Der p 1, Der p 2 or Der p 23 performed at most 12 months prior to inclusion. 3.c. Specific IgE ≥0.7 kU/L against at least one of the following major allergens: Der p 1, Der p 2 or Der p 23. performed at most 12 months prior to the inclusion visit. 3.d. Positive CFP to the mixture extract of the purified allergens Der p 1/Der p 2/Der p 23.
- Asthmatic patients with a forced expiratory volume in the first second (FEV1) ≥ 80%.
- Women of childbearing age should have a negative urine pregnancy test (childbearing is defined as from menarche to postmenopause, unless sterilized by hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and be willing to use an effective method of contraception from 14 days before the first administration until 30 days after the last administration of the investigational drug.
- Patients willing to comply with all study procedures, and have availability for follow-up for the duration of the study.
You likely can't join if
- Any total contraindication to treatment with allergen-specific immunotherapy or defined within the study according to the SmPC. In case of partial contraindication, the investigator will perform a personalized benefit/risk assessment.
- Recent or anticipated nasal or paranasal surgery (e.g., polyposis) that may interfere with the trial, at the investigator's discretion
- Moderate to severe atopic dermatitis.
- Severe or uncontrolled asthma according to GINA 20245 guidelines or unstable asthma (i.e., clinically relevant exacerbations in the 3 months prior to inclusion), including a baseline FEV1<80%. NOTE: clinically relevant exacerbations are defined as any worsening of asthma requiring hospitalizations or emergency department visits and necessitating systemic corticosteroid therapy for ≥ 3 consecutive days, or any exacerbation requiring initiation or increase in baseline systemic corticosteroid intake for ≥ 3 consecutive days
- Patients/legal representatives who decline to participate or do not sign informed consent or assent.
- Pregnant or lactating women.
See the full eligibility criteria
Who can join
- Patients/legal representatives who have understood and signed the informed consent or assent form.
- Patients between 12 and 65 years of age, both inclusive.
- Patients with moderate or severe persistent allergic rhinitis and/or rhinoconjunctivitis (according to ARIA2 guidelines) for at least the last year, caused by clinically relevant sensitization to Dermatophagoides genus, fulfilling all the criteria described below: 3.a. Clinical history with symptoms compatible with demonstrated hypersensitivity to the genus Dermatophagoides. 3.b. Positive skin prick test (papule of ≥3 mm with respect to the negative control) against at least one of the following major allergens: Der p 1, Der p 2 or Der p 23 performed at most 12 months prior to inclusion. 3.c. Specific IgE ≥0.7 kU/L against at least one of the following major allergens: Der p 1, Der p 2 or Der p 23. performed at most 12 months prior to the inclusion visit. 3.d. Positive CFP to the mixture extract of the purified allergens Der p 1/Der p 2/Der p 23.
- Asthmatic patients with a forced expiratory volume in the first second (FEV1) ≥ 80%.
- Women of childbearing age should have a negative urine pregnancy test (childbearing is defined as from menarche to postmenopause, unless sterilized by hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and be willing to use an effective method of contraception from 14 days before the first administration until 30 days after the last administration of the investigational drug.
- Patients willing to comply with all study procedures, and have availability for follow-up for the duration of the study.
What rules you out
- Any total contraindication to treatment with allergen-specific immunotherapy or defined within the study according to the SmPC. In case of partial contraindication, the investigator will perform a personalized benefit/risk assessment.
- Recent or anticipated nasal or paranasal surgery (e.g., polyposis) that may interfere with the trial, at the investigator's discretion
- Moderate to severe atopic dermatitis.
- Severe or uncontrolled asthma according to GINA 20245 guidelines or unstable asthma (i.e., clinically relevant exacerbations in the 3 months prior to inclusion), including a baseline FEV1<80%. NOTE: clinically relevant exacerbations are defined as any worsening of asthma requiring hospitalizations or emergency department visits and necessitating systemic corticosteroid therapy for ≥ 3 consecutive days, or any exacerbation requiring initiation or increase in baseline systemic corticosteroid intake for ≥ 3 consecutive days
- Patients/legal representatives who decline to participate or do not sign informed consent or assent.
- Pregnant or lactating women.
- Severe uncontrolled systemic disease that poses a risk to participants, including but not limited to autoimmune, cardiovascular or hematologic disease, hyperthyroidism, clinically relevant liver or kidney disease, malignant tumors or chronic infection, severe unstable pulmonary disease as judged by a physician.
- Contraindication to the use of adrenaline.
- Active HIV infection
- Active tuberculosis.
- Dermographism, skin disease or skin disorders that interfere with the evaluation of skin tests.
- Any total contraindication for SmPC. In case of partial contraindication, the investigator will perform a personalized assessment (e.g., chronic or infectious conjunctivitis/polyposis).
- Psychiatric disorder that prevents adequate compliance with the immunotherapy program.
- Patients on current psychiatric treatment that interferes with diagnostic testing (e.g., tricyclic antidepressants). In case of needing psychiatric medication, this should not be withdrawn in order to be included in the study.
- Concurrent participation in another clinical trial.
- Non-cooperative attitude or non-compliance or taking medication to control allergic rhinitis/rhinoconjunctivitis symptoms other than that provided in this study.
- Current drug or alcohol abuse or abuse during the previous year, or any substance abuse that may interfere with the trial in the investigator's discretion.
- History of allergic reaction to any of the excipients present in the investigational product formulation.
- Patients sensitized to epithelials (e.g. cat, dog, horse, mouse) who live with these animals or have frequent contact with them (direct or indirect)
- Patients with clinically relevant sensitization to storage mites (mainly Lepidoglyphus destructor or Blomia tropicalis) at the investigator's discretion.
- Patients with clinically relevant sensitization to fungi (mainly Alternaria alternata) at the investigator's discretion.
- Use of other immunotherapy against D. pteronyssinus or other house dust mites (D. farinae) for more than one month in the last 5 years.
- Current treatment with any type of immunotherapy with other allergens during the study period.
- Current treatment or during the previous 16 weeks with any biological agent for allergic rhinoconjunctivitis and/or atopic dermatitis and/or any other non-allergic disease (dupilumab, benralizumab, mepolizumab, omalizumab, tezepelumab, among others).
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, 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.