Phase III clinical trial to evaluate the efficacy and safety of specific immunotherapy with mannanconjugated allergoids for the treatment of rhinitis/rhinoconjunctivitis in patients allergic to house dust mites.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmunotek S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

18 Nov 2025 → ongoing

Decision date (initial)

2025-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Inmunotek S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary objective of this trial is to evaluate the clinical efficacy of EP-088_MM09 at 3,000 mTU/mL administered subcutaneously, compared to placebo in subjects aged 12 to 65 years old with moderate-to-severe persistent rhinitis/rhinoconjunctivitis with or without mild-to-moderate intermittent or persistent controlled asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae

Secondary objectives 6

1. To assess the safety and clinical tolerability of EP-088_MM09.
2. To assess the clinical benefit of the EP-088_MM09 on the different efficacy parameters compared to placebo and baseline.
3. To assess the effect of the EP-088_MM09 on the immunological status of subjects compared to placebo and baseline.
4. To assess the clinical effect of the EP-088_MM09 on the quality of life and symptom control compared to placebo and baseline.
5. To assess the effect of the EP-088_MM09 on the consumption of health resources related to study pathologies and baseline.
6. To evaluate the clinical efficacy of EP-088_MM09 compared to placebo with the mean of the daily scores (RCSMS) adjusted to baseline scores.

Conditions and MedDRA coding

Aetiological treatment of moderate-to-severe allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate controlled allergic asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Subjects who have signed and dated Informed Consent Form (ICF).
2. 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, bilateral tubal occlusion, vasectomised partner, or sexual abstinence.
3. Subjects capable of complying with dosage regimen.
4. Subjects with negative skin prick test for moulds.
5. Subjects must record symptoms and medication consumption in a n electronic diary (preferably) or in a paper diary.
6. To be confirmed at visit 1 (V1) Only subjects who meet the following criteria will be eligible for randomization: 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.
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.
12. 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 26

1. Subjects sensitised (positive skin prick test) to one or more pollens where the time interval between baseline visit (BV) and additional baseline visit (ABV) os more than 7 months.
2. Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit.
3. Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit.
4. Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria.
5. 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.
6. Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies.
7. Subjects that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness.
8. Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens.
9. Subjects with lower respiratory tract diseases, different from asthma, as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
10. 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).
11. 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.
12. 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.
13. 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.
14. Breastfeeding or pregnant women.
15. Subjects who are immediate family members of the investigator.
16. Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit.
17. Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc.
18. 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.
19. 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)
20. 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.
21. 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).
22. 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.
23. Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors.
24. Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug.
25. 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.
26. Subjects with controlled or uncontrolled cancer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject’s Diary

Secondary endpoints 17

1. Rhinitis/Rhinoconjunctivitis Symptom Score (RSS)
2. Rhinitis/Rhinoconjunctivitis Medication Score (RMS)
3. Asthma-Combined Symptom and Medication Score (ACSMS)
4. Asthma Symptom Score (ASS)
5. Asthma Medication Score (AMS)
6. Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
7. Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)
8. Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)
9. Asthma exacerbations: time to first asthma exacerbation; number, duration, and severity
10. Immunological parameters:  Total IgE  Specific IgE and IgG4  Specific IgE/Total IgE ratio  Anti-Saccharomyces cerevisiae antibodies (ASCA) IgA and IgG
11. Allergen profiling (ALEX technique)
12. Asthma Quality of Life Questionnaire (AQLQ)
13. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
14. Asthma Control Questionnaire (GINA 2023)
15. Visual Analogue Scale (VAS)
16. Consumption of Health Resources
17. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmunotek S.L.

Sponsor organisation

Inmunotek S.L.

Address

Calle Punto Mobi 5

City

Alcala De Henares

Postcode

28805

Country

Spain

Scientific contact point

Organisation

Inmunotek S.L.

Contact name

Medical Department

Public contact point

Organisation

Inmunotek S.L.

Contact name

Medical Department

Third parties 2

Locations

2 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications