AzTrials
AzTrials

Allergic RhinitisPhase 3MM09-SIT-063NCT07904052

Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.

A Phase 3 study testing EP-088_MM09 in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Inmunotek S.L. at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
EP-088_MM09
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
16 sitesin 2 countries
Study dates
24 Feb 2026to Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects who have signed and dated Informed Consent Form (ICF).
  • Female or male aged 12 to 65 years, both included.
  • Subjects with confirmed clinical history of inhalation allergy with moderate-severe persistent rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year duration (treated with anti-allergic medication) with or without mild-moderate intermittent or persistent controlled asthma according to the definition of GINA 2023(2) caused by D. pteronyssinus and/or D. farinae. The asthma diagnosis will be valid up to 12 months prior to signing the informed consent.
  • Subjects with positive skin prick test to a standardized allergen extract of D. pteronyssinus and/or D. farinae. The wheal major diameter must be ≥ 5 mm and greater than or equal to the wheal major diameter of the positive control (histamine). The results will be valid up to 12 months prior to the signature of the informed consent.
  • Subjects with 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. The results will be valid up to 12 months prior to the signature of the informed consent.
  • 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:
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  • Subjects with a positive skin prick test for Blomia tropicalis, and/or Lepidoglyphus destructor and/or other mites. The specific IgE value for these allergens must be ≤ 3.5 kU/L.
  • Subjects with positive skin prick test for dander may be included, provided that they have occasional exposure and symptoms. Subjects with habitual exposure to dander or living with animals must have a negative prick test.
  • Subjects sensitised (positive prick test) to one or more pollens who must carry out the first symptom and medication collection (after baseline visit (BV) or additional baseline visit (ABV)) and last symptom and medication collection period (after visit 12), according to the following conditions:
  • 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 postmenopause, 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 contraception method during the trial and up to 1 months after the end of the investigational 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).

Who cannot join

  • Subjects sensitised (positive prick test) to one or more pollens where the time interval between baseline visit (BV) and additional baseline visit (ABV) is more than 7 months.
  • Subjects who have received previous immunotherapy to allergens under study (D. pteronyssinus and D. farinae) during the last 5 years or currently receiving immunotherapy with any other allergen.
  • Subjects who have undergone any desensitisation process (e.g., oral immunotherapy [OIT], milk, or egg) except those in the maintenance phase since at least 12 months.
  • Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)
  • Subjects with uncontrolled asthma, according to GINA 2023(2),asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization.
  • Asthmatic subjects with forced expiratory volume in the first second (FEV1) <80% despite pharmacological treatment. The result shall be valid up to 12 months prior to signing of informed consent (See Section 9.2).
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  • Subjects with severe asthma, according to GINA 2023(2), on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
  • Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors.
  • Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug.
  • Subjects requiring regular treatment with systemic corticosteroids (oral or injectable) for the treatment of rhinitis/rhinoconjunctivitis and asthma. The regular use of topical, cutaneous, or inhaled corticosteroids for the treatment of the pathologies mentioned above and atopic dermatitis is permitted.
  • Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit.
  • Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit.
  • Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.
  • Subjects with other severe disease not related asthma or rhinitis/rhinoconjunctivitis that could interfere in the study treatment or the follow-up (e.g., epilepsy or nephropathy) according to investigator's criteria.
  • Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies.
  • Subjects that could not comply with the study protocol, according to investigator's criteria, or have a serious mental illness.
  • Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens.
  • Subjects with lower respiratory tract diseases, different from asthma, as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
  • Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) within the deadlines set out in the protocol (See Section 9.2).
  • Subjects having any nasal condition (e.g., nasal polyp or non-allergic rhinitis) that could affect an appropriate evaluation of the efficacy and/or safety, according to investigator's criteria.
  • Subjects who required regular treatment with antihistamines and/or corticosteroids (systemic - oral or injectable-, topical, cutaneous, or inhaled) for other purposes than alleviating symptoms of allergic rhinitis, except temporal use (≤ 15 days) for diseases including common colds.
  • Breastfeeding or pregnant women.
  • Subjects who are immediate family members of the investigator.
  • Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit.
  • Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc.
  • Subjects with controlled or uncontrolled cancer.

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Raquel Caballero contact

607600638

rcaballero@inmunotek.com

Marta Romero contact

mromero@inmunotek.com

16 sites in 2 countries

Spain10 sites, 7 recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Active, not recruiting

  • H. Vithas Medimar

    Alicante, 03016

    Lucía Sánchez-Cendal González, MD, 965 162 200

    Ángel Ferrer Torres, MD

    Not yet recruiting

  • H. U. San Juan de Alicante

    Alicante, 03550

    Active, not recruiting

  • Hospital Universitari Consorci Sanitari de Terrassa

    Barcelona, 08227

    Active, not recruiting

  • Hospital Sant Joan de Déu Barcelona

    Barcelona, 08950

    Raquel Masip, +34 936 009 733

    Adriana Machinena, MD

    Recruiting

  • Hospital La Plana

    Ciudad Real, Castellón, 12540

    María Nieto, (+34) 964399961

    Francisco D El-Qutob López, MD

    Not yet recruiting

  • Clínica Privada Dr. Barceló

    Málaga, 29001

    Manuel Barceló, MD, (+34) 952 120102

    Manuel Barceló, MD

    Recruiting

  • Hospital U. Regional de Málaga

    Málaga, 29009

    José Manuel Escobosa, MD, 951290224

    Carmen Rondón, MD

    Recruiting

  • H. U. de Melilla

    Melilla, 52005

    Arturo Ruiz, MD, (+34) 656583277

    Arturo Ruiz, MD

    Not yet recruiting

  • H.U. de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

    Yolanda Marrero Curbelo, 922677232

    María Inmaculada Sánchez Machín, MD

    Recruiting

Other trials in Spain

Portugal6 sites, 6 recruiting

  • Unidade Local de Saúde de Coimbra, EPE

    Coimbra, 3004-561

    José Pedro, 351 966 329 15 2, jose.pedro@ulscoimbra.min-saude-pt

    Federico Regateiro, MD

    Not yet recruiting

  • Unidade Local de Saúde de São José, EPE

    Lisbon, 1150-199

    Ana Cunha, +351 213 596 401, ana.sofia.cunha@ulssjose.min-saude.pt

    Margarida Ferreira, +351 213 596 401, ensaiosclinicos@ulssjose.min-saude.pt

    Not yet recruiting

  • Unidade Local de Saúde de Santa Maria, EPE

    Lisbon, 1649-035

    Ana Lopes, +351 210 405 814, anafilop@gmail.com

    Sara Lopes, +351 914 800 511, sarafp.ensaioscic@gmail.com

    Not yet recruiting

  • Hospital CUF Descobertas

    Lisbon, 1998-018

    Ingrid Gouveia, +351 910 446 771, ingrid.gouveia@jmellosaude.pt

    João Antunes, MD

    Not yet recruiting

  • Unidade Local de Saúde de Santo António, EPE

    Porto, 4099-001

    Cláudia Santos, +351 222 077 508 ext. 1508, geral.investigacao.defi@chporto.min-saude.pt

    Marta Gomes, +351 222 077 508 ext. 1508, u71852@chporto.min-saude.pt

    Not yet recruiting

  • Hospital CUF Porto

    Porto, 4100-180

    Maria Catarina Magalhães, MD, +351 914 683 830, maria.c.magalhaes@cuf.pt

    Joana Santos, MD, jmdmsantos@hotmail.com

    Not yet recruiting

Other trials in Portugal

About this study

Official title: Prospective, Randomised, Double-blind, Placebo-controlled Multicenter Trial of Efficacy and Safety of D. Pteronyssinus and D. Farinae Mannan-conjugated Allergoids in Patients With Rhinitis/Rhinoconjunctivitis Allergic to HDM

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.

Read more

The main questions are:

  • Does the treatment lower allergy symptoms and the need for symptom-relief medicines compared with a placebo?
  • What medical problems or reactions occur during treatment?

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:

  • Attend one or two visits before starting treatment to check whether they can take part.
  • Attend 12 treatment visits, approximately once a month, to receive injections under the skin. They will receive two injections at the first treatment visit and one at each later visit.
  • Stay at the clinic for at least 30 minutes after each injection.
  • Record symptoms and medication use daily during specified periods.
  • Complete questionnaires about their symptoms and quality of life, and provide blood samples.
  • Attend a final visit about one month after the last treatment visit.

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.

Read the detailed description

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.

Being tested
EP-088_MM09, Placebo
Keywords
allergy vaccines, Dermatophagoides pteronyssinus, Dermatophagoides farinae, allergic rhinitis, allergic rhinoconjunctivitis, allergic asthma
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EP-088_MM09Biological

    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.

  • PlaceboBiological

    The composition of the placebo IMP is as follows:

    • Identical in composition to the active IMP, but without active ingredients.
Study groups in NCT07904052
Study groupRoleWhat they receive
mixture of Dermatophagoides (group 1)ExperimentalGroup 1 will receive subcutaneous EP-088-MM09 at a concentration of 3,000 mTU/mL.
Receives: Biological: EP-088_MM09
Placebo (group 2)Placebo comparatorGroup 2: will receive subcutaneous placebo, identical in composition to the active IMP, but without active ingredients.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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)

Secondary outcomes (16)

  1. 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.

    Measured: 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)

  2. 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

    Measured: 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)

  3. 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

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: 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)

  8. Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score

    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.

    Measured: 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)

  9. Asthma exacerbations

    Time to first asthma exacerbation, number, duration, and severity

    Measured: From visit 1 to the end of treatment at 12 months

  10. Immunological parameters in blood samples

    Total IgE Specific IgE and IgG4 Specific IgE/Total IgE ratio Anti-Saccharomyces cerevisiae antibodies (ASCA) (IgA and IgG)

    Measured: In Baseline Visit or Visit 1 and in the Final visit

  11. 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.

    Measured: At the end of the study

  12. 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.

    Measured: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12

  13. 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.

    Measured: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12

  14. 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

    Measured: Baseline visit and visit 12

  15. 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.

    Measured: Baseline Visit, Additional Baseline visit, visit 3, visit 6, visit 9 and visit 12

  16. 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.

    Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start24 Feb 2026
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

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, double-blind, placebo-controlled, multicenter, efficacy, and safety clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904052
Sponsor's protocol ID
MM09-SIT-063
Acronym
MM09-SIT-063
Status last verified
Oct 2026
First submitted
27 Aug 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EP-088_MM09 in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Inmunotek S.L. at 16 sites in 2 countries.

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 18 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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, Portugal. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raquel Caballero (607600638, rcaballero@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) 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)). 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 NCT07904052.

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 29 Oct 2026.

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