Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Inmunotek

Status and phase: Terminated; Phase 3

Conditions: Pollen Allergy; House Dust Mite Allergy; Perennial Allergic Rhinitis; Allergic Rhinoconjunctivitis

Treatments: Biological: Placebo subcutaneous; Biological: MM09(30.000); Biological: MG01(30.000); Biological: MM09-MG01(30.000-30.000)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04874714

DMV01-SIT-015

2018-003715-22 (EudraCT Number)

Details and patient eligibility

About

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and allergic rhinitis/rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen

Full description

Double blind, parallel placebo-controlled study. The subjects will receive medication during 11 months

Enrollment: 18 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who have signed the informed consent

2. Subjects with a confirmed medical history of asthma (intermittent or persistent mild-moderate, controlled), as defined by GEMA 5 with moderate-severe rhinitis / rhinoconjunctivitis (intermittent or persistent) according to the ARIA classification caused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D. farinae). The diagnosis of asthma will be valid from 24 months prior to signing the informed consent.

3. Subjects with a positive prick test (major diameter of the papule ≥ to 5 mm) to a standardized extract of grass pollen mixture, or to one of the components of the mixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleum pratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D. farinae. Results will be valid 12 months prior to signing the informed consent.

4. Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense or a mixture of grasses and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value > 3,5 KU / L. Results will be valid 12 months prior to signing the informed consent.

5. Subjects will preferably be sensitive to study allergens (Dermatophagoides and grasses). In the case of subjects sensitized to other aeroallergens, only those with the following characteristics (results valid up to 12 months prior to signing of the informed consent) can be included in the study:

   1. Subjects with a positive prick test for Blomia tropicalis and Lepidoglyphus destructor, whose maximum values of specific IgE are 3.5 KU/L and do not exceed or equal the values of the allergens of the study (Dermatophagoides and grasses).
   2. Subjects with a negative prick test to epithelium, whose specific IgE values are < 0.35 KU/L. Subjects with occasional exposure and symptomatology to epithelium may be included with a positive prick test regardless of the value of the specific IgE.
   3. Subjects with a positive prick test for non-coestational pollens, whose maximum values of specific IgE are 17.5 KU / L and do not exceed or equal the values of the allergens of the study (Dermathophagoids and grasses) and who also do not present exacerbations in the pollen season.

6. Subjects with a negative prick test for fungi. If the specific IgE determination has been made, the result shall be < 0,35 KU/L.

7. Subjects with a negative prick test for coestacional pollens with grasses. If the specific IgE determination has been made, the result shall be < 0,35 KU/L.

8. Subjects aged between 12 and 65 years, inclusive.

9. Subjects capable of complying with the dosing regimen.

10. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial.

11. Women of childbearing potential should commit to using an adequate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.

12. Subjects who have a smartphone to record symptoms and medication.

Exclusion criteria

1. Subjects who have received prior immunotherapy treatment in the preceding 5 years for any aeroallergen.
2. Patients in whom immunotherapy may be the object of 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 cannot be included.
3. Subjects with severe or uncontrolled asthma, and / or with a FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial.
4. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
5. Subjects under treatment with ß-blockers.
6. Subjects under treatment with immunosuppressive or biological drugs.
7. Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.).
8. Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema.
9. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
10. Subjects 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, diabetes, malformations, subjects who underwent multiple surgeries, kidney disease...), according to investigator's criteria.
11. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies.
12. Subject whose condition prevents him / her from offering cooperation and or who resents severe psychiatric disorders, according to investigator criteria.
13. Subjects with known allergies to other investigational product components other than grass pollen or mites.
14. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
15. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 4 patient groups, including a placebo group

MM09-MG01(30.000-30.000)

Experimental group

Description:

30,000 AU/mL of MM09 and 30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months

Treatment:

Biological: MM09-MG01(30.000-30.000)

MG01(30.000)

Experimental group

Description:

30,000 AU/mL of MG01 of subcutaneous immunotherapy once a month for 11 months

Treatment:

Biological: MG01(30.000)

MM09(30.000)

Experimental group

Description:

30,000 AU/mL of MM09 of subcutaneous immunotherapy once a month for 11 months

Treatment:

Biological: MM09(30.000)

Placebo subcutaneous

Placebo Comparator group

Description:

The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Treatment:

Biological: Placebo subcutaneous