A Phase 3 interventional study of 10,000 MM09 and 30,000 MM09 in Rhinitis, Allergic, Rhinoconjunctivitis and Asthma, Allergic, sponsored by Inmunotek S.L.. Recruiting at 32 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment
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.
Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 150 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10,000 TU/mL of subcutaneous immunotherapy
Biological: 10,000 MM09
30,000 TU/mL of subcutaneous immunotherapy
Biological: 30,000 MM09
The same solution and presentation as the active treatment, but without any active ingredients.
Biological: Placebo subcutaneous
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
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
The same solution and presentation as the active treatment, but without active ingredients.
CSMS: Combined Symptoms and Medication Score
Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.
Time frame: 12 months
Medication-free days
Number of days that the subjects need no medication
Time frame: 12 months
Symptom-free days
Number of days that the subjects have no symptom
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-023
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 12 months
Quality of life associated with asthma
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
Time frame: 12 months
Quality of life associated with rhinitis
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).
Time frame: 12 months
Visual Analogue Scale (VAS)
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.
Time frame: 12 months
Immunological parameters
Analyses of total IgE and specific IgA,IgG and IgG4
Time frame: 12 months
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Plan to share: No
Started Oct 2020 (actual). Primary completion is estimated for Dec 2026, 74 months after the start.
Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 74 months is above that.
Counting every sponsor, half of 41 studies reached it within 13 months; a quarter within 6 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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