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Tests treatment safety and results for Rhinitis, Allergic
Official title Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
ClinicalTrials.gov ID: NCT04891237
What this study is testing
What is 10,000 MG01 + 10,000 T517?
10,000 MG01 + 10,000 T517 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rhinitis, allergic.
Also referred to as Grasses and olea 10,000.
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
- Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- 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
- Subject who has signed the informed consent.
- people of both sexes aged between 12 and 65 years.
- people with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis...
- people with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus...
- Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense...
You likely can't join if
- people polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
- people polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
- people who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
- 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 persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological...
- people who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
See the full eligibility criteria
- Subject who has signed the informed consent.
- people of both sexes aged between 12 and 65 years.
- people with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or...
- people with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne)...
- Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with...
- Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
- Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least...
- people capable of complying with the dosage regimen.
- people who have a smartphone to record symptoms 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 polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
- people polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
- people who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
- 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 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 with...
- people who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- people under treatment with ß-blockers.
- Clinically unstable people at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
- people with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, 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 the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
- people with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity 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 him / her from offering cooperation and who has severe psychiatric disorders.
- people with a known allergy to other investigational drug components other than the allergen.
- people with diseases of the lower respiratory tract 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
- Tarancón, Cuenca, Spain
- Alcalá de Henares, Madrid, Spain
- Tres Cantos, Madrid, Spain
- Valdemoro, Madrid, Spain
- El Palmar, Murcia, Spain
- Albacete, Spain
- Ávila, Spain
- Badajoz, Spain
- Barcelona, Spain
- Ciudad Real, Spain
- Córdoba, Spain
- Granada, Spain
- Jaén, Spain
- Lleida, Spain
- Madrid, Spain
- Málaga, Spain
- Murcia, Spain
- Palencia, Spain
- Parla, Spain
- Seville, Spain
+ 2 more site(s).
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 1 year 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 Tarancón, Cuenca, Spain; Alcalá de Henares, Madrid, Spain; Tres Cantos, Madrid, Spain; Valdemoro, Madrid, Spain; El Palmar, Murcia, Spain; Albacete, Spain and 16 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.