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Tests treatment safety and results for Rhinitis, Allergic
Official title Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
ClinicalTrials.gov ID: NCT04898283
What this study is testing
What is 10,000 MG01 +10,000 T521?
10,000 MG01 +10,000 T521 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rhinitis, allergic.
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
- A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- Written informed consent.
- Aged between 12 and 65, both genders
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification...
- people with a positive skin prick-test (wheal size \>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus...
- Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite).
You likely can't join if
- people with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms.
- people with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses.
- people who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently...
- people in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the...
- people with severe or uncontrolled intermittent or persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate...
- people who have previously had a severe secondary reaction during the prick test diagnostic skin test.
See the full eligibility criteria
- Written informed consent.
- Aged between 12 and 65, both genders
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according...
- people with a positive skin prick-test (wheal size \>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne)...
- Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite).
- Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.
- Women of childbearing potential participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months...
- people capable of complying with the dosing regimen.
- people who own a smartphone for symptom registration and medication.
- people with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology
- people with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology.
- people with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms.
- people with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses.
- people who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
- people in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European...
- people with severe or uncontrolled intermittent or persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise...
- people who have previously had a severe secondary reaction during the prick test diagnostic skin test.
- people treated with beta-blockers.
- Clinically unstable people at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
- people with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
- people who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).
- people with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes...
- people with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
- Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders.
- people with a known allergy to components of the investigational medicinal product other than the allergen.
- people with lower respiratory diseases other than asthma such as emphysema or bronchiectasis.
- people who are direct relatives of the researchers.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Valladolid, Castille and León, Spain
- Tarancón, Cuenca, Spain
- Alcalá de Henares, Madrid, Spain
- Alcorcón, Madrid, Spain
- Madrid, Madrid, Spain
- Majadahonda, Madrid, Spain
- Murcia, Murcia, Spain
- Ávila, Spain
- Barcelona, Spain
- Burgos, Spain
- Collado Villalba, Spain
- León, Spain
- Madrid, Spain
- Palencia, Spain
- Salamanca, Spain
- Segovia, Spain
- Soria, Spain
- Zaragoza, Spain
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 study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valladolid, Castille and León, Spain; Tarancón, Cuenca, Spain; Alcalá de Henares, Madrid, Spain; Alcorcón, Madrid, Spain; Madrid, Madrid, Spain; Majadahonda, Madrid, Spain and 12 more location(s). 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.