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Tests treatment safety and results for Rhinitis, Allergic
Official title Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
ClinicalTrials.gov ID: NCT04435990
What this study is testing
What is 10,000 MM09?
10,000 MM09 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 double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
- Phase 3: a large, late-stage study
- 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.
- Age between 12 and 65, both genders.
- people with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis...
- people with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The...
- Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus...
You likely can't join if
- people who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
- people in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the...
- people with persistent severe or uncontrolled asthma, with an FEV1\<70% of baseline despite adequate pharmacological treatment at the time of...
- people who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- people under treatment with β-blockers.
- Clinically unstable people at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute...
See the full eligibility criteria
- Written informed consent.
- Age between 12 and 65, both genders.
- people with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or...
- people with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent...
- Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular...
- people should preferably be monosensitized to the study allergens. In case of people sensitized to other aeroallergens, only those with the following characteristics may be included in the study:
- people with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens...
- people with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
- people with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of...
- people with negative skin test for fungi
- Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.
- Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they...
- people with a diagnosis of asthma according to the GEMA 5.0 guideline.
- people capable of complying with the dosing regimen.
- people who own an smartphone for symptom registration and medication
- people who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
- people in whom 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 persistent severe or uncontrolled asthma, with an FEV1\<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also people with intermittent or persistent...
- people who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- people under treatment with β-blockers.
- Clinically unstable people at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
- people with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
- people with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled...
- 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/or who has serious mental illness.
- people with a known allergy to other components of the investigational medicinal product other than the allergen.
- people with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- Direct investigator's relatives.
- Pregnant women or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Santiago de Compostela, A Coruña, Spain
- Elche, Alicante, Spain
- Torrevieja, Alicante, Spain
- Valencia, Alzira, Spain
- Algeciras, Cadiz, Spain
- Jerez de la Frontera, Cádiz, Spain
- Valencia, España, Spain
- Cartagena, Murcia, Spain
- Vigo, Pontevedra, Spain
- Alicante, Spain
- Badajoz, Spain
- Barcelona, Spain
- Bilbao, Spain
- Cadiz, Spain
- Córdoba, Spain
- Lugo, Spain
- Málaga, Spain
- Melilla, Spain
- Murcia, Spain
- Santander, 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 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, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago de Compostela, A Coruña, Spain; Elche, Alicante, Spain; Torrevieja, Alicante, Spain; Valencia, Alzira, Spain; Algeciras, Cadiz, Spain; Jerez de la Frontera, Cádiz, 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.