MM09-SIT-023: Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Sponsor

Inmunotek S.L. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04435990

Collaborator

(none)

150

Enrollment

Locations

Arms

61.8

Anticipated Duration (Months)

8.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 mild to moderate asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic Rhinoconjunctivitis Asthma, Allergic	Biological: 10,000 MM09 Biological: 30,000 MM09 Biological: Placebo subcutaneous	Phase 3

Detailed Description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled, multi centre, parallel-group studyRandomized, double-blind, placebo-controlled, multi centre, parallel-group study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed. So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blinded, Placebo-controlled, Prospective, Multicenter Trial to Evaluate the Efficacy and Safety of SIC in Subjects With Mild/Moderate Asthma and Rhinitis/Rhinoconjunctivitis Sensitized to D.Pteronyssinus and/or D. Farinae

Actual Study Start Date :

Oct 6, 2020

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental:10,000 MM09 10,000 TU/mL of subcutaneous immunotherapy	Biological: 10,000 MM09 Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
Experimental: Experimental: 30,000 MM09 30,000 TU/mL of subcutaneous immunotherapy	Biological: 30,000 MM09 Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
Placebo Comparator: Placebo subcutaneous The same solution and presentation as the active treatment, but without any active ingredients.	Biological: Placebo subcutaneous The same solution and presentation as the active treatment, but without active ingredients.

Arm

Intervention/Treatment

Experimental: Experimental:10,000 MM09

10,000 TU/mL of subcutaneous immunotherapy

Biological: 10,000 MM09

Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL

Experimental: Experimental: 30,000 MM09

30,000 TU/mL of subcutaneous immunotherapy

Biological: 30,000 MM09

Placebo Comparator: Placebo subcutaneous

The same solution and presentation as the active treatment, but without any active ingredients.

Biological: Placebo subcutaneous

The same solution and presentation as the active treatment, but without active ingredients.

Outcome Measures

Primary Outcome Measures

CSMS: Combined Symptoms and Medication Score [12 months]
Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.

Secondary Outcome Measures

Medication-free days [12 months]
Number of days that the subjects need no medication
Symptom-free days [12 months]
Number of days that the subjects have no symptom
Number of participants with treatment-related adverse events as assessed by MM09-SIT-023 [12 months]
Comparison between the beginning and end of the trial and among active groups and placebo
Quality of life associated with asthma [12 months]
The quality of life associated with asthma will be measured following the GINA questionnaire. The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO. The interpretation of the answers is as follows: Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES
Quality of life associated with rhinitis [12 months]
The quality of life associated with rhinitis will be measured following the test ESPRINT-15. The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items). The interpretation of the scores is between 0 (low impact) and 6 (high impact).
Visual Analogue Scale (VAS) [12 months]
Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well.
Immunological parameters [12 months]
Analyses of total Ig3 and specific IgA,IgG and IgG4

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent.
Age between 14 and 65, both genders.
Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate intermittent or persistent asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent form
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
Specific immunoglobulin E against house dust mites >3 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
Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.
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 asthmatic pathology made by means of a bronchodilator test or subjects with a previous diagnosis of asthma according to the GEMA 5.0 guideline due to clinical history.
Subjects capable of complying with the dosing regimen.
Subjects who own an smartphone for symptom registration and medication

Exclusion Criteria:

Subjects outside of the age range.
Subjects polysensitized to other aeroallergens in addition to Dermatophagoides pteronyssinus and Dermatophagoides farinae, except for epithelia with exposure and occasional symptoms.
Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or an allergen with cross-reactivity or are currently receiving immunotherapy with any allergen.
Subjects 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 Allergy and Clinical Immunology Immunotherapy Subcommittee.
Subjects have not granted written informed consent.
Subjects with severe or uncontrolled intermittent or 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, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
Subjects who required oral corticosteroids in the 12 weeks prior to enrollment in the trial.
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 active chronic urticaria, severe dermography, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests are performed, or a history of hereditary angioedema.
Subjects that have some pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
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, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
Subject whose status prevents him from offering cooperation and or who has severe psychiatric disorders.
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 or women at risk of pregnancy and breastfeeding women.

Contacts and Locations

Locations

	Site	City	State	Country
1	Eugenia Margarita Campos	Elche	Alicante	Spain
2	Clinica Virgen del Rosario	Algeciras	Cadiz	Spain
3	Allergocenter	Barcelona		Spain
4	Centro privado Barcelona	Barcelona		Spain
5	Cenvi Medic	Barcelona		Spain
6	César Alías	Barcelona		Spain
7	Clinica privada	Bilbao		Spain
8	Centro Médico ASISA Dr. Lobatón	Cadiz		Spain
9	Centro médico puerto	Cadiz		Spain
10	Hospital Quiron Salud Córdoba	Córdoba		Spain
11	Hospital HLA Jerez Puerta Sur	Jerez De La Frontera		Spain
12	Joaquín Martín	Lugo		Spain
13	Clinica privada	Málaga		Spain
14	Quirón	Palma De Mallorca		Spain
15	Alergocantabria	Santander		Spain
16	Clinica IMED	Valencia		Spain
17	Clinica Tecma Alzira	Valencia		Spain

Sponsors and Collaborators

Inmunotek S.L.

Investigators

Principal Investigator: Daniel Pujadas, MD, Quirón Palma de Mallorca
Principal Investigator: Mario Tubella, MD, Cenvi Medic, Barcelona
Principal Investigator: Alfonso Malet, MD, Allergocentre, Barcelona
Principal Investigator: Miguel Ángel Añó, MD, Alergocantabria, Santander
Principal Investigator: Miguel Herrías, MD, Clinica Privada Bilbao
Principal Investigator: Antonio Letrán, MD, Hospital HLA Jeréz Puerta del Sur
Principal Investigator: Diego Gutiérrez, MD, Clínica Virgen del Rosario, Algeciras
Principal Investigator: Ignacio Garcia, MD, Clinica Quirón Salud, Córdoba
Principal Investigator: Manuel Barceló, MD, Clinica Privada, Málaga.
Principal Investigator: Mº José Pereira, MD, Centro Médico Puerto, Jerez
Principal Investigator: Isabella Raducán, MD, Clínica TECMA, Alzira
Principal Investigator: Noelia Colomer, MD, Clínica IMED, Valencia
Principal Investigator: Eugenia Margarita Campos, MD, Clínica IMED, Elche
Principal Investigator: César Alías, MD, Clínica Corachan, Barcelona
Principal Investigator: Joaquín Martín, MD, Hospital POLUSA, Lugo