Efficacy and safety of MG01 and T517 drug combination in patients with allergic rhinitis or rhinoconjunctivitis, with or without mild‑moderate asthma
- Trial ID
- 2024-514525-34-00
- Protocol
- DMV03-SIT-027
- Sponsor
- Inmunotek S.L.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this clinical trial is to evaluate the **clinical efficacy** of subcutaneously administered polymerized allergen extracts compared to placebo in subjects with **rhinitis/rhinoconjunctivitis** according to the ARIA classification, with or without controlled intermittent or persistent (mild-moderate) **asthma**, as defined by GEMA 5.0. This evaluation is clinically relevant as it aims to determine the potential of these allergen extracts to provide therapeutic benefits in managing symptoms associated with these conditions, which are common and can significantly impact quality of life.
Secondary objectives include assessing the safety and efficacy of the polymerized extracts under the specified conditions by comparing the active and placebo groups at both the beginning and the end of the study on all secondary variables. This assessment is crucial for understanding the broader implications of treatment, including any adverse effects and overall effectiveness in symptom management.
Participants
The clinical trial involves a study population comprising **both male and female** subjects aged between 12 and 65 years. Participants are individuals with a confirmed clinical history of inhalation allergy, specifically moderate-severe intermittent or persistent **allergic rhinitis/rhinoconjunctivitis** with or without controlled mild-moderate intermittent or persistent allergic asthma. The trial population was selected based on specific criteria, including a positive skin prick test to standardized mixed extracts of grass pollen or olive tree extract, and specific IgE levels greater than 3.5 kU/L. Participants are required to have a negative skin prick test for co-seasonal pollens and other aeroallergens, and women of childbearing age must present a negative urine pregnancy test and agree to use an appropriate method of contraception. The trial does not specify the total number of participants, as this information was not provided by the sponsor. Lifestyle considerations include the ability to comply with the dosing regimen and the requirement for participants to own a smartphone for recording symptoms and medication. The study includes a vulnerable population, as indicated by the selection criteria.
Plans and Procedures
This clinical trial is a **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the efficacy and safety of subcutaneous immunotherapy in patients with **allergic rhinitis/rhinoconjunctivitis** with or without mild to moderate asthma, sensitized to grasses and olive tree pollen. The trial will involve the administration of a mixture of modified allergen extracts of six grasses and olive pollen, compared to a placebo, which is an identical solution without active ingredients. The trial is expected to last until October 31, 2025, with participant recruitment having commenced on June 14, 2021.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, clinical history of inhalation allergy, and specific **IgE** levels. Following successful screening, participants will be randomized to receive either the active treatment or placebo. The trial will include regular follow-up visits to monitor the participants' health, assess the primary endpoint of overall symptom and medication score during the pollen season, and evaluate secondary endpoints such as symptom-free days, medication-free days, and asthma exacerbations. Immunological parameters, including total IgE and specific IgG4, will also be assessed.
The expected length of participant involvement is up to 12 months, corresponding to the maximum treatment period. Conditions that may lead to early termination from the study include the occurrence of severe adverse events, non-compliance with the dosing regimen, or withdrawal of consent. The end-of-study visit will involve a comprehensive assessment of the participant's health status and the collection of final data for analysis. The trial aims to provide valuable insights into the safety and efficacy of the investigational treatment for individuals affected by these allergic conditions.
Treatment
The clinical trial involves the administration of a **mixture of modified allergen extracts** of six grasses (MG01) and a modified allergen extract of olive pollen (T517). This experimental medication is formulated as a **suspension for injection**. The active substances include allergenic extracts from Olea europaea pollen polymerized with glutaraldehyde, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Poa pratensis pollen, Dactylis glomerata pollen, and Lolium perenne pollen, all modified with glutaraldehyde. The medication is administered via the **subcutaneous route**. The maximum daily dose is 0.5 ml, with a total maximum dose of 0.5 ml per administration. The treatment period extends up to 12 months. Participant compliance is monitored through regular follow-ups and adherence checks.
The study also includes a **placebo** group, which receives an identical solution and presentation as the active treatment but without active ingredients. The placebo is administered in the same pharmaceutical form and via the same route as the experimental medication, ensuring blinding of the study. The placebo is also given subcutaneously, with the same dosing schedule and frequency as the active treatment. This design allows for a direct comparison of the efficacy and safety of the experimental treatment against the placebo.
Efficacy
The efficacy of the clinical trial will be assessed using a combination of primary and secondary endpoints. The primary endpoint is the overall symptom and medication score during the grass and olive tree pollen season, specifically in the months of April, May, and June. This will provide a comprehensive measure of the treatment's impact on the symptoms of **rhinitis/rhinoconjunctivitis** and the necessity for medication.
Secondary endpoints include a variety of measures to further evaluate efficacy. These include the number of symptom-free days, medication-free days, and the frequency of asthma exacerbations. Additionally, patient-reported outcomes will be collected using the Visual Analogue Scale (VAS), the Asthma Control Questionnaire (ACQ-6), and the Rhinitis Quality of Life Questionnaire (ESPRINT-15). Immunological parameters such as total IgE, specific IgE, and specific IgG4 levels will also be measured to assess the immunological response to the treatment. The consumption of health resources and the safety of specific immunotherapy, including the overall rate, severity, and ratio of any adverse events, will be monitored. This will include assessments of administration site reactions, systemic reactions, and any medication administered for the treatment of adverse events.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Subject who has signed the informed consent form.
- Subjects of both sexes aged between 12 and 65 years.
- Subjects with a confirmed clinical history of inhalation allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without controlled intermittent or persistent mild-moderate asthma according to the GEMA 5.0 classification) caused by grass and olive tree allergy. The asthma diagnosis will be valid from 12 months prior to signing the informed consent.
- Subjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and an olive tree extract.
- Specific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and olive tree or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L.
- Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.
- Women of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligation), barrier methods, or the use of oral contraceptives.
- Subjects capable of complying with the dosing regimen.
- Subjects owning a smartphone to record symptoms and medication.
- Subjects with negative skin prick test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
- Subjects with negative skin prick test to other aeroallergens (mites, fungi, and dander). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
Exclusion Criteria
- Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.
- Subjects with positive skin prick test to other aeroallergens, except for non-co-seasonal pollens with grasses and olive tree.
- Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.
- Subjects in whom immunotherapy may be subject to 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 discontinuation of oral or systemic antihistamine treatment is contraindicated.
- Subjects who have previously presented a severe secondary reaction during diagnostic skin prick test.
- Subjects on treatment with ß-blockers.
- Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile 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 pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- 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.), tumour diseases or diagnosed with immunodeficiencies.
- Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.
- Subjects with known allergy to components of the investigational medicinal product other than the allergen.
- Subjects with lower respiratory tract diseases different from asthma such as emphysema or bronchiectasis.
- Subjects who are immediate family members of investigators.
- Pregnant or breastfeeding women.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Recruiting | 14 Jun 2021 | 180 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Mixture of modified allergen extracts of 6 grasses (MG01) and modified allergen extract of olive pollenT517 | Test | SUSPENSION FOR INJECTION | SUBCUTANEOUS USE | 0.5 | 12 | PRD10395113 |
Mixture of modified allergen extracts of 6 grasses (MG01) and modified allergen extract of olive pollenT517 | Test | SUSPENSION FOR INJECTION | SUBCUTANEOUS USE | 0.5 | 12 | PRD10395195 |
Identical solution and presentation as the active treatment, but without active ingredients. | Placebo | N/A | — | — | — | N/A |