House Dust Mite AllergyPhase 3NCT05400811
Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis
A Phase 3 study testing MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL), MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL) and MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL) in people with House Dust Mite Allergy and Perennial Allergic Rhinitis, run by Inmunotek S.L. at 16 sites in Spain.
Trial summary
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 rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- House Dust Mite Allergy, Perennial Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL), MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL) and MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 16 sitesSpain
- Study dates
- Dec 2022to Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 60 years, both included.
- Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
- Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
- Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
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- Women of childbearing age must commit to using an adequate contraception method.
- Capable of complying with dosage regimen.
- Owning a smartphone to register symptoms and medication consumption.
- A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance.
Who cannot join
- Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
- Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
- Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
- Intake of β-blockers.
- Use of immunosuppressive or biological drug.
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- Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
- Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
- Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
- Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
- Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
- Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
- Known allergy to any of the ingredients of the study medication except for mites.
- Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
- Breast-feeding or pregnant women.
- Being immediate family of the investigator.
- Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
- History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Hospital Universitario A Coruña
A Coruña, 15006
Antonio Parra Arrondo, MD, PhD
Hospital General Universitario de Alicante
Alicante, 03010
Luis Moral, MD, PhD
Centro Médico Quiron Salud Alicante
Alicante, 03015
Angel Ferrer, MD, PhD
Hospital Universitario de Elche
Elche, Alicante, 03203
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Adriana Machinena, MD. PhD
Policlínica Nuestra Sra del Rosario
Ibiza Town, Balearic Islands, 07800
Silvia Martínez Blanco, MD, PhD
Hopital Quirón Salud Málaga
Málaga, 29004
Leticia Herrero Lifona, MD, PhD
Clinica del Dr.Pérez Estrada Cornejo
Málaga, 29005
Manuel Pérez Estrada Cornejo, MD. PhD
Hospital Universitario Regional de Málaga
Málaga, 29010
Carmén Rondón, MD, PhD
Clínica RUSADIR
Melilla, 52006
Oliver Alexis Muñoz Daga, MD, PhD
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Ana Isabel Tabar Purroy, MD. PhD
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, 36071
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Inmaculada Sánchez Machin, MD, PhD
Hospital de Terrassa
Terrassa, Barcelona, 08227
Marta Viñas, MD. PhD
Hospital Univeristario y Politécnico La Fe
Valencia, 46026
Hospital Universitario de la Plana
Vila-real, 12540
Francisco David El-Qutob López, MD. PhD
About this study
Official title: Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.
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 rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
Read the detailed description
Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms.
The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 months.
- Conditions
- House Dust Mite Allergy, Perennial Allergic Rhinitis, Allergic Rhinoconjunctivitis, Allergic Asthma
- Being tested
- MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL), MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL), MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL), Placebo subcutaneous, Placebo sublingual
- Keywords
- Rhinitis/ Rhinoconjunctivitis, Allergy, Immunotherapy, Mild to moderate asthma
- Medical subject headings
- Dust Mite Allergy, Rhinitis, Allergic, Perennial, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)Biological
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.
MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)Biological
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.
MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)Biological
Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.
Placebo subcutaneousBiological
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Placebo sublingualBiological
The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo | Experimental | Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3,000 UTm/mL subcutaneous immunotherapy + sublingual placebo.
Subcutaneous active treatment will be administered once a month for 12 months. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. Receives: Biological: MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL); Biological: Placebo sublingual |
| Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo | Experimental | Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 3.000 UTm/mL + subcutaneous placebo.
Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months.
Subcutaneous placebo will be administered once a month for 12 months. Receives: Biological: MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL); Biological: Placebo subcutaneous |
| Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo | Experimental | Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 9.000 UTm/mL + subcutaneous placebo.
Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months.
Subcutaneous placebo will be administered once a month for 12 months. Receives: Biological: MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL); Biological: Placebo subcutaneous |
| Group IV: Placebo | Placebo comparator | Mixture of sublingual placebo + subcutaneous placebo. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months.
Subcutaneous placebo will be administered once a month for 12 months Receives: Biological: Placebo subcutaneous; Biological: Placebo sublingual |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSMS: Combined Symptoms and Medication Score
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.
- The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe
Total daily symptom score = 0-3
The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide.
The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3
Measured: 12 months
Secondary outcomes (17)
Asthma symptom-free days
Number of days that subjects have no symptoms related to asthma
Measured: 12 months
Rhinitis / rhinoconjunctivitis symptom-free days
Number of days that subjects have no symptom related to rhinitis / rhinoconjunctivitis.
Measured: 12 months
Asthma medication-free days
Number of days that subjects need no medication for treatment of asthma.
Measured: 12 months
Rhinitis / rhinoconjunctivitis medication-free days
Number of days that subjects need no medication for treatment of Rhinitis / rhinoconjunctivitis.
Measured: 12 months
Respiratory function_FEV1
Measurement of Forced Expiratory Volume in 1 Second (FEV1) %
Measured: Baseline, month 6, month 12
Respiratory function_PEF
Peak Expiratory Flow (PEF) [velocity]
Measured: Baseline, month 6, month 12
Asthmatic exacerbations
Time elapsed until the first appearance of asthmatic exacerbations, number, duration and severity.
Measured: 12 months
Clinical benefit
Time to onset of clinical benefit
Measured: 12 months
Immunological parameters
Analyses of total and specific IgE, specific IgE index / total IgE, specific IgG4 and Anti-Saccharomyces cerevisiae (ASCA) IgA\&IgG.
Measured: 12 months
Quality of life associated with asthma (AQLQ)
The quality of life associated with asthma will be measured using the Asthma Quality of Life Questionnaire (AQLQ).
AQLQ consists of 32 items and 4 domains (limitations in activities, symptoms, emotional and environmental). Each item is scored from 1=no impairment to 7=severe impairment.
Measured: 12 months
Quality of life associated with rhinoconjunctivitis (RQLQ)
The quality of life associated with rhinoconjunctivitis will be measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
RQLQ it consists of 28 items (questions) and 7 domains (Activities, sleep, general symptoms, practical problems, nose symptoms, eye and emotional symptoms).
The score of each item for all domains, except for the emotional one, ranges from "0=Nothing bothered me" to "6=It has bothered me a lot". The emotional domain score ranges from "0=Never" to "6=Always".
Measured: Baseline, month 6, month 12
Questionnaire for asthma control (ACQ)
Asthma control will be measured following the ACQ questionnaire.
The ACQ questionnaire consists of 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from "0 = fully controlled" to "6 = extremely poorly controlled"). The seventh question, which refers to the% FEV1 of the reference value, must be completed by an employee of the site. The questionnaire score is the mean of the 7 responses (ACQ-7) or 6 responses (ACQ-6).
The interpretation of the scores is as follows:
Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control
Measured: 12 months
Visual Analogue Scale (VAS)
Visual Analogue Scale in which the subject has to indicate in a straight line of 10 cm how he/she feels regarding to his allergy symptoms. Being left side "0 = very bad" and right side "10 = very well".
VAS scale will also be completed by the investigator answering how he/she thinks that the patient feels.
Measured: 12 months
Consumption of health resources
For each patient, the number of times that due to allergy symptoms has done the following will be counted:
- have visited the family doctor
- have made an unscheduled visit to the specialist
- has gone to the emergency room
- has been hospitalized
- have needed to contact the doctor by phone
Measured: 12 months
Safety parameters
Global rate and severity of AE per administration and per subject
Measured: 12 months
Number of Local Adverse Reactions
Local adverse reactions are those that appear at the site of the administration. They are classified into: Immediate (it appears during the first 30 minutes from the administration of investigational product) and Late (it appears after the first 30 minutes from the administration of investigational product)
Measured: 12 months
Number of Systemic Adverse Reactions
Systemic adverse reactions are those that appear in other parts of the body other than the site of administration.Their severity will be classified following the indications proposed by the World Allergy Organization (WAO) in 2010.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startDec 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for House Dust Mite AllergyStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled, double-blind, double-dummy, multi-center trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioClever 2005 S.L., NTS hub S.L
- Responsible party
- Sponsor
- Investigators
- Ana Isabel Tabar Purroy, MD. PhD, Principal investigator, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400811
- Sponsor's protocol ID
- MM09-SIT-040
- Status last verified
- Apr 2022
- First submitted
- 27 May 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benito-Villalvilla C, Soria I, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to mannan. Allergo J Int. 2018;27(8):256-262. doi: 10.1007/s40629-018-0069-8. Epub 2018 May 18.
PubMed 30546997Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13.
PubMed 27177779Manzano AI, Javier Canada F, Cases B, Sirvent S, Soria I, Palomares O, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Subiza JL. Structural studies of novel glycoconjugates from polymerized allergens (allergoids) and mannans as allergy vaccines. Glycoconj J. 2016 Feb;33(1):93-101. doi: 10.1007/s10719-015-9640-4. Epub 2015 Nov 25.
PubMed 26603537Soria I, Lopez-Relano J, Vinuela M, Tudela JI, Angelina A, Benito-Villalvilla C, Diez-Rivero CM, Cases B, Manzano AI, Fernandez-Caldas E, Casanovas M, Palomares O, Subiza JL. Oral myeloid cells uptake allergoids coupled to mannan driving Th1/Treg responses upon sublingual delivery in mice. Allergy. 2018 Apr;73(4):875-884. doi: 10.1111/all.13396. Epub 2018 Jan 31.
PubMed 29319882Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23.
PubMed 28778325Gonzalez JL, Zalve V, Fernandez-Caldas E, Cases B, Subiza JL, Casanovas M. A pilot study of immunotherapy in dogs with atopic dermatitis using a mannan-Dermatophagoides farinae allergoid targeting dendritic cells. Vet Dermatol. 2018 Oct;29(5):449-e152. doi: 10.1111/vde.12679.
PubMed 30183126
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.
- ClinicalTrials.gov ID
- NCT05400811
- Acronym / sponsor ID
- MM09-SIT-040
- Conditions
- House Dust Mite Allergy, Perennial Allergic Rhinitis, Allergic Rhinoconjunctivitis, Allergic Asthma
- Keywords
- Rhinitis/ Rhinoconjunctivitis, Allergy, Immunotherapy, Mild to moderate asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Collaborators
- BioClever 2005 S.L., NTS hub S.L
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
Detailed description
Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms.
The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective, randomized, placebo-controlled, double-blind, double-dummy, multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo | Experimental | Biological: MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL), Biological: Placebo sublingualMixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3,000 UTm/mL subcutaneous immunotherapy + sublingual placebo. Subcutaneous active treatment will be administered once a month for 12 months. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. |
| Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo | Experimental | Biological: MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL), Biological: Placebo subcutaneousMixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 3.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months. |
| Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo | Experimental | Biological: MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL), Biological: Placebo subcutaneousMixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan sublingual immunotherapy at 9.000 UTm/mL + subcutaneous placebo. Sublingual active treatment will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months. |
| Group IV: Placebo | Placebo comparator | Biological: Placebo subcutaneous, Biological: Placebo sublingualMixture of sublingual placebo + subcutaneous placebo. Sublingual placebo will be administered daily (2 subsequent administrations) for 12 months. Subcutaneous placebo will be administered once a month for 12 months |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Signed and dated Informed Consent Form (ICF).
- Female or male aged 12 to 60 years, both included.
- Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
- Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
Key exclusion criteria (18 listed)
- Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
- Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
- Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
- Intake of β-blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration. | Biological | Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo |
| MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration. | Biological | Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo |
| MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration. | Biological | Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo |
| Placebo subcutaneousThe same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients. | Biological | Group II: MM09 allergoid-mannan conjugates SL (3.000 UTm/mL) + subcutaneous placebo, Group III: MM09 allergoid-mannan conjugates SL (9.000 UTm/mL) + subcutaneous placebo, Group IV: Placebo |
| Placebo sublingualThe same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients. | Biological | Group I: MM09 allergoid-mannan conjugates SC (3.000 UTm/mL) + sublingual placebo, Group IV: Placebo |
Primary outcome
CSMS: Combined Symptoms and Medication Score
Time frame: 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. - The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe Total daily symptom score = 0-3 The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide. The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3
17 secondary outcomes
Asthma symptom-free days
Time frame: 12 months
Rhinitis / rhinoconjunctivitis symptom-free days
Time frame: 12 months
Asthma medication-free days
Time frame: 12 months
Rhinitis / rhinoconjunctivitis medication-free days
Time frame: 12 months
Respiratory function_FEV1
Time frame: Baseline, month 6, month 12
Respiratory function_PEF
Time frame: Baseline, month 6, month 12
Asthmatic exacerbations
Time frame: 12 months
Clinical benefit
Time frame: 12 months
Immunological parameters
Time frame: 12 months
Quality of life associated with asthma (AQLQ)
Time frame: 12 months
Quality of life associated with rhinoconjunctivitis (RQLQ)
Time frame: Baseline, month 6, month 12
Questionnaire for asthma control (ACQ)
Time frame: 12 months
Visual Analogue Scale (VAS)
Time frame: 12 months
Consumption of health resources
Time frame: 12 months
Safety parameters
Time frame: 12 months
Number of Local Adverse Reactions
Time frame: 12 months
Number of Systemic Adverse Reactions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Background: PubMed 30546997Benito-Villalvilla C, Soria I, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to mannan. Allergo J Int. 2018;27(8):256-262. doi: 10.1007/s40629-018-0069-8. Epub 2018 May 18.
- Background: PubMed 27177779Sirvent S, Soria I, Cirauqui C, Cases B, Manzano AI, Diez-Rivero CM, Reche PA, Lopez-Relano J, Martinez-Naves E, Canada FJ, Jimenez-Barbero J, Subiza J, Casanovas M, Fernandez-Caldas E, Subiza JL, Palomares O. Novel vaccines targeting dendritic cells by coupling allergoids to nonoxidized mannan enhance allergen uptake and induce functional regulatory T cells through programmed death ligand 1. J Allergy Clin Immunol. 2016 Aug;138(2):558-567.e11. doi: 10.1016/j.jaci.2016.02.029. Epub 2016 Apr 13.
- Background: PubMed 26603537Manzano AI, Javier Canada F, Cases B, Sirvent S, Soria I, Palomares O, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Subiza JL. Structural studies of novel glycoconjugates from polymerized allergens (allergoids) and mannans as allergy vaccines. Glycoconj J. 2016 Feb;33(1):93-101. doi: 10.1007/s10719-015-9640-4. Epub 2015 Nov 25.
- Background: PubMed 29319882Soria I, Lopez-Relano J, Vinuela M, Tudela JI, Angelina A, Benito-Villalvilla C, Diez-Rivero CM, Cases B, Manzano AI, Fernandez-Caldas E, Casanovas M, Palomares O, Subiza JL. Oral myeloid cells uptake allergoids coupled to mannan driving Th1/Treg responses upon sublingual delivery in mice. Allergy. 2018 Apr;73(4):875-884. doi: 10.1111/all.13396. Epub 2018 Jan 31.
- Background: PubMed 28778325Soria I, Alvarez J, Manzano AI, Lopez-Relano J, Cases B, Mas-Fontao A, Canada FJ, Fernandez-Caldas E, Casanovas M, Jimenez-Barbero J, Palomares O, Vinals-Florez LM, Subiza JL. Mite allergoids coupled to nonoxidized mannan from Saccharomyces cerevisae efficiently target canine dendritic cells for novel allergy immunotherapy in veterinary medicine. Vet Immunol Immunopathol. 2017 Aug;190:65-72. doi: 10.1016/j.vetimm.2017.07.004. Epub 2017 Jul 23.
- Background: PubMed 30183126Gonzalez JL, Zalve V, Fernandez-Caldas E, Cases B, Subiza JL, Casanovas M. A pilot study of immunotherapy in dogs with atopic dermatitis using a mannan-Dermatophagoides farinae allergoid targeting dendritic cells. Vet Dermatol. 2018 Oct;29(5):449-e152. doi: 10.1111/vde.12679.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Isabel Tabar Purroy, MD. PhD principal investigator
Hospital of Navarra
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL), MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL) and MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL) in people with House Dust Mite Allergy and Perennial Allergic Rhinitis, run by Inmunotek S.L. at 16 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Casanovas, MD, PhD (912908942 ext. 0034, mcasanovas@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSMS: Combined Symptoms and Medication Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400811, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.