A Phase 3 interventional study of EP-088_MM09 and Placebo in Allergic Rhinitis, Allergic Rhinoconjunctivitis and Allergic Asthma, sponsored by Inmunotek S.L.. Recruiting at 16 sites in 2 countries. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to learn whether EP-088_MM09 works to treat house dust mite allergy. It will also assess the treatment's safety. EP-088_MM09 contains modified house dust mite allergens called mannan-conjugated allergoids.
The study plans to include 250 participants aged 12 to 65 years. They will have persistent, moderate to severe nasal allergy symptoms, with or without eye symptoms. Participants may also have mild or moderate allergic asthma, provided it is controlled.
The main questions are:
Researchers will assess how well the treatment works using a score combining symptoms and medication use. The main assessment will cover four weeks after the treatment course.
Participants will be assigned by chance to receive either EP-088_MM09 or a placebo. They will have an equal chance of receiving either treatment. The placebo looks like EP-088_MM09 but contains no active ingredients. Neither participants nor study doctors will know which treatment each participant receives.
Each participant will be in the study for approximately 14 to 21 months.
Participants will:
Participants who are also sensitive to pollen may need a second visit before starting treatment. This is needed if their first visit falls during the relevant pollen season or within one month before or after it.
The study consists of a screening/baseline phase, a treatment phase and a final follow-up assessment.
The screening/baseline phase establishes each participant's symptom burden and use of allergy medication before treatment begins. Participants will record this information in a diary during defined assessment periods before and during treatment.
For participants who are also sensitised to pollen, the timing of assessments is designed to limit the influence of pollen exposure on the evaluation of house dust mite allergy. An additional baseline visit may therefore be required, depending on when the initial visit occurs relative to the relevant pollen season. The final symptom and medication assessment period will also be scheduled outside that pollen season, according to protocol-defined timing requirements. These scheduling arrangements account for variation in the overall duration of participation.
During treatment, the study team will review diary completion, concomitant medication and participants' health. Participants will also complete questionnaires and provide blood samples at scheduled visits.
The final follow-up assessment will take place approximately one month after the last treatment visit. It will include review of the final diary entries, medication use and any ongoing medical problems.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 250 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.
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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 shall preferably be monosensitised to the study allergens. In the case of subjects sensitised to other aeroallergens, only those with the following characteristics (results valid 12 months prior to signing the informed consent form) may be included in the study:
1. Both symptom and medication collection periods must be carried out outside the pollen season.
2. Both symptom and medication collection periods must start at least one month before and one month after the pollen season.
An individual assessment of each subject will be performed in conjunction with the pollen calendar established for each geographical region to check that symptom and medication collection can be carried out under the above conditions. If this is not possible, subjects cannot be included in the study.
7. Subjects with negative skin prick test for moulds. 8. Women of childbearing age (i.e., following menarche and until , defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must confirm menarche and have a urine pregnancy test negative result before enrolling the study.
9. Women of childbearing age must commit to using a highly effective method during the trial and up to 1 months after the end of the medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal, contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomised partner, or sexual abstinence.
10. Subjects capable of complying with dosage regimen. 11. Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary.
To be confirmed at visit 1 (V1)
Only subjects who meet the following criteria will be eligible for randomization:
12. Subjects with a rhinitis/rhinoconjunctivitis combined symptom and medication score (RCSMS) ≥ 2 out of 6, recorded for at least 10 days, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis (See Section 6.2).
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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 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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 will receive subcutaneous EP-088-MM09 at a concentration of 3,000 mTU/mL.
Biological: EP-088_MM09
Group 2: will receive subcutaneous placebo, identical in composition to the active IMP, but without active ingredients.
Biological: Placebo
The composition of the active IMP (EP-088\_MM09) is as follows: * Dermatophagoides pteronyssinus mannan-conjugated (polymerized) allergoid. * Dermatophagoides farinae mannan-conjugated (polymerized) allergoid. The concentration of the Dermatophagoides mixture is 3,000 mTU/mL. Inmunotek has found it convenient to define 1 mTU (Therapeutic Unit of mannan) as the result of polymerising and conjugating 10 biological units of the corresponding semi-purified native extract with mannan.
The composition of the placebo IMP is as follows: • Identical in composition to the active IMP, but without active ingredients.
Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject's Diary
The combination score of symptoms and medication required for symptom control in rhinitis/rhinoconjunctivitis for each subject during the trial will be obtained by means of the Subject's diary. RCSMS corresponds to the sum of Rhinitis/rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/rhinoconjunctivitis Medication Score (RMS). The assessment criteria for each symptom shall be as follows: * 0 = No symptoms * 1 = Mild symptoms * 2 = Moderate * 3 = Severe The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis symptoms (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), divided by six: The final score will range from 0 to 3. RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. The daily RCSMS is calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3).
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Rhinitis/Rhinoconjunctivitis Symptom Score (RSS)
The RSS will correspond to the sum of the six rhinitis/rhinoconjunctivitis (itchy/red eyes, watery eyes, sneezing, itchy nose, runny nose, blocked nose), symptoms divided by six: (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final score will range from 0 to 3. The assessment criteria for each symptom shall be as follows: * 0 = No symptoms (no obvious symptoms). * 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2 = Moderate (annoying but not disabling or intolerable). * 3 = Severe (disabling and/or intolerable). The Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Rhinitis/Rhinoconjunctivitis Medication Score (RMS)
RMS will correspond to the highest level of medication taken on this day. The final RMS score will range from 0 to 3. Medication to assess rhinitis/rhinoconjunctivitis: * Oral and/or topical (eyes or nose) non-sedative H1 antihistamines (H1A). * Intranasal corticosteroids (INS) with/ without H1A. * Oral corticosteroids (OCS) with/without INS, with/without H1A. The Rhinitis/Rhinoconjunctivitis Medication Score (RMS) will be obtained throughout the different trial periods for each subject by means of the Subject's Diary
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma Combined Symptom and Medication Score (ACSMS)
The Asthma-Combined Symptom and Medication Score (ACSMS) will be obtained throughout the different trial periods for each subject with asthma using the data from the Subject's Diary. The ACSMS will correspond to the sum of ASS and AMS and will be calculated as follows: ACSMS (0-6) = ASS (0-3) + AMS (0-3) The final score will range from 0 to 6
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma Symptom Score (ASS)
The Asthma Symptom Score (ASS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma by means of the Subject's Diary. Asthma symptoms are the following: * Cough. * Wheezing. * Shortness of breath or feeling of choking. * Chest tightness. The endpoint for each symptom will be as follows: * 0 = No symptoms (no obvious symptoms). * 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2 = Moderate (annoying but not disabling or intolerable). * 3 = Severe (disabling and/or intolerable). The ASS will correspond to the sum of the four asthma symptoms (cough, wheezing, shortness of breath or feeling of choking, and chest tightness) divided by four: (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma Medication Score (AMS)
The asthma medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2023 guidelines. The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal." In the present study, the asthma medication will be scored as follows: * Score 0.5: SABA as needed. * Score 1: Low dose ICS with/without SABA as needed. * Score 1.5: Low dose ICS + LABA or medium dose ICS with/without SABA as needed. * Score 2: Medium dose ICS+LABA with/without SABA as needed. * Score 2.5: High dose ICS+LABA with/without SABA as needed. * Score 3: High dose ICS+LABA + systemic corticosteroids with/without LTRA with/without SABA as needed. The AMS will correspond to the highest level of medication taken on this day. The final score will range from 0 to 3.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
The Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARSS will correspond to the sum of RSS and ASS and will be calculated as follows: ARSS (0-6) = RSS (0-3) + ASS (0-3) The final score will range from 0 to 6.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)
The Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) will be obtained throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARMS will correspond to the sum of RMS and AMS and will be calculated as follows: ARMS (0-6) = RMS (0-3) + AMS (0-3) The final score will range from 0 to 6.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)
The Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS) will be counted throughout the different trial periods (See Flow-chart in 9.1) for each subject with asthma using the data from the Subject's Diary. The ARCSMS will correspond to the sum of RCSMS and ACSMS and will be calculated as follows: ARCMS (0-12) = RCSMS (0-6) + ACSMS (0-6) The final score will range from 0 to 12.
Time frame: Baseline Visit or Additional Baseline visit (2 weeks), visit 3 (2 weeks), visit 6 (2 weeks), visit 9 (2 weeks) and visit 12 (4 weeks)
Asthma exacerbations
Time to first asthma exacerbation, number, duration, and severity
Time frame: From visit 1 to the end of treatment at 12 months
Immunological parameters in blood samples
Total IgE Specific IgE and IgG4 Specific IgE/Total IgE ratio Anti-Saccharomyces cerevisiae antibodies (ASCA) (IgA and IgG)
Time frame: In Baseline Visit or Visit 1 and in the Final visit
Allergen profiling (ALEX technique)
Allergen profiling assessed using the Allergy Explorer (ALEX) multiplex assay to determine sensitization patterns to allergen extracts and molecular allergen components. Results will be used to characterize participants' allergen sensitization profiles.
Time frame: At the end of the study
Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 items and 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Each item is scored from 1 ("severe impairment") to 7 ("no impairment"). This questionnaire shall be completed by the subject at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9, and V12.
Time frame: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) consists of 28 items (questions) and 7 domains (Activities Limitation, Sleep Problems, Non-Nose/Eye Symptoms, Practical Problems, Nose Symptoms, Eye Symptoms and Emotional Function). The score for each item for all domains, except for the emotional function domain, ranges from 0 ("not troubled") to 6 ("extremely troubled"). The score for the emotional domain ranges from 0 ("Never") to 6 ("Always"). This questionnaire shall be completed by the subject at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9, and V12.
Time frame: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12
Asthma Control Questionnaire (GINA 2023)
The Asthma Control Questionnaire (GINA 2023) consists of 4 questions. To assess symptom control, the investigator will ask about the following in the past four weeks: frequency of asthma symptoms (days per week), any night waking due to asthma or limitation of activity and, for patients using a SABA reliever, frequency of its use for relief of symptoms. The interpretation of the answered questions is as follows: * Well controlled asthma: All answered questions are "No" * Partly controlled asthma: 2 answered questions are "Yes" * Uncontrolled: 3-4 answered questions are "Yes" This questionnaire shall be completed by the subject at BV, and V12
Time frame: Baseline visit and visit 12
Visual Analogue Scale (VAS)
The visual analogue scale is a 10 cm straight line, where the left end means that the subject feels very well, and the right end means that the subject feels very bad. * Subject's VAS, where the subject will mark a dot on the line that matches his or her health status with respect to allergy symptoms. * Investigator's VAS, where the investigator will mark a dot on the line that matches the subject's health status with respect to allergy symptoms. The VAS shall be completed by the participant and investigator at BV (subjects no sensitised to pollens or sensitised to pollens who do not have to attend the ABV), ABV (subjects sensitised to pollens who have to attend this visit), V3, V6, V9 and V12 in separate documents.
Time frame: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12
Consumption of health resources
For each subject, the number of times during the study period that he/she has performed the following due to allergy symptoms shall be counted: * has visited the general practitioner. * has made an unscheduled visit to a specialist. * went to the emergency room. * has been hospitalised. * needed to contact the doctor by telephone.
Time frame: From enrollment to the end of treatment at 12 months
Safety parameters
* Overall rate and severity of adverse events (AEs) per administration and per subject. * Evaluation of reactions at the site of administration, systemic reactions and of any medications administered for the treatment of the adverse reaction (AR).
Time frame: From enrollment to the end of treatment at 12 months
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Plan to share: Undecided
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