NCT04435990 Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
| NCT ID | NCT04435990 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Inmunotek S.L. |
| Condition | Rhinitis, Allergic |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-10-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2020-10-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Written informed consent. * Age between 12 and 65, both genders. * Subjects 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 persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent. * Subjects 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 results. The results will be valid 12 months prior to the signing of the informed consent. * 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 components of these allergenic sources * Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study: * Subjects 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 is 3.5 KU/L. * Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology. * Subjects 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 specific IgE for these allergens is 17.5 KU/L. * Subjects 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 are sexually active. * Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline. * Subjects capable of complying with the dosing regimen. * Subjects who own an smartphone for symptom registration and medication Exclusion Criteria: * Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites. * Subjects 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 Allergy and Clinical Immunology Immunotherapy Subcommittee. * Subjects 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 subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated. * Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test. * Subjects under treatment with β-blockers. * Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.). * Subjects 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. * Subjects 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 diabetes, malformations, multiple surgeries, nephropathy). * Subjects 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. * Subjects with a known allergy to other components of the investigational medicinal product other than the allergen. * Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis. * Direct investigator's relatives. * Pregnant women or breastfeeding women.
Contact & Investigator
Francisco Moreno, MD
STUDY DIRECTOR
Centro Médico ASISA
Frequently Asked Questions
Who can join the NCT04435990 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Rhinitis, Allergic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04435990 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT04435990 currently recruiting?
Yes, NCT04435990 is actively recruiting participants. Contact the research team at mcasanovas@inmunotek.com for enrollment information.
Where is the NCT04435990 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Elche, Spain, Torrevieja, Spain, Valencia, Spain and 11 additional locations.
Who is sponsoring the NCT04435990 clinical trial?
NCT04435990 is sponsored by Inmunotek S.L.. The principal investigator is Francisco Moreno, MD at Centro Médico ASISA. The trial plans to enroll 150 participants.