Clinical trial to assess the efficacy and safety of a vaccine for dust mite and Lepidoglyphus destructor allergy.

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]

Decision date (initial)

2026-05-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Inmunotek S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective of this trial is to evaluate the clinical efficacy of the investigational medicinal product (IMP) at 30,000/30,000 TU/mL, administered subcutaneously, compared with placebo, in participants aged 12 to 65 years with moderate-to-severe persistent rhinitis/rhinoconjunctivitis with or without controlled intermittent or persistent mild-to-moderate asthma, allergic to Dermatophagoides and Lepidoglyphus destructor.

Secondary objectives 6

1. To evaluate the clinical efficacy of glutaraldehyde-polymerized allergen extracts compared with placebo using the mean daily score (RCSMS) adjusted for baseline values.
2. To evaluate the safety and clinical tolerability of glutaraldehyde-polymerized allergen extracts.
3. To evaluate the clinical benefit of glutaraldehyde-polymerized allergen extracts accross different efficacy parameters compared with placebo and baseline.
4. To evaluate the effect of glutaraldehyde-polymerized allergen extracts on the immunological status of participants compared with placebo and baseline.
5. To evaluate the clinical effect of glutaraldehyde-polymerized allergen extracts on quality of life and symptom control compared with placebo and baseline.
6. To evaluate the effect of glutaraldehyde-polymerized allergen extracts on healthcare resource utilization related to the study pathologies and the baseline situation.

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. Participants who have signed the informed consent form.
2. Male or female participants aged 12 to 65 years, inclusive.
3. Participants with a confirmed clinical history of inhalant allergy with moderate-to-severe persistent rhinitis/rhinoconjunctivitis according to ARIA classification (1) of at least 1 year duration (treated with antiallergic medication) with or without controlled intermittent or persistent mild-to-moderate asthma according to the definition of GEMA 5.5, (2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Lepidoglyphus destructor. The asthma diagnosis will be valid up to 12 months prior to signing the informed consent.
4. Participants with positive skin prick test to standardized extracts of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Lepidoglyphus destructor. The major diameter of the wheal must be ≥ 5 mm and greater than or equal to the major diameter of the wheal of the positive control (histamine). The results will be valid up to 12 months prior to the signature of the informed consent.
5. Specific IgE ≥3.5 kU/L against a complete extract of D. pteronyssinus and/or D. farinae and Lepidoglyphus destructor 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.
6. Of participants sensitized to other aeroallergens, only those meeting the following criteria may be included in the study (results valid up to 12 months prior to the signing of the informed consent form): a) Participants with a positive skin prick test to animal dander may be included only if exposure and related symptoms are occasional. Participants with regular exposure to animal dander or who live with animals must have a negative skin prick test to these danders. b) Participants sensitized (positive skin prick test) to one or more pollens must complete the first symptom and medication recording period (after the Baseline Visit (BV) under the following conditions: 1. The first symptom and medication recording period must be carried out outside the pollen season. 2. The first symptom and medication recording period must begin at least one month before or one month after the pollen season. 3. Participants who do not meet both condition 1 and condition 2 at the time of the Baseline Visit (BV) will be considered a screening failure. These participants may be re-screened and re-included at a later time (see Section 7.3.3). In addition, the final symptom and medication recording period (after Visit 12 (V12)) must also be conducted in accordance with conditions 1 and 2 described above. An individual assessment of each participant will be performed in conjunction with the pollen calendar established for each geographical region to verify that symptom and medication recording can be carried out under the conditions described above. If this is not possible, the participant may not be included in the study
7. Participants with a negative skin prick test to molds.
8. Women of childbearing potential (i.e., from menarche until postmenopause, defined as the absence of menstruation for 12 months without an alternative medical cause, and who have not undergone permanent sterilization procedures such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) must have experienced menarche and present a negative urine pregnancy test at the time of study inclusion.
9. Women of childbearing potential must agree to use a highly effective contraceptive method throughout the study and for 1 month after completion of treatment with the investigational medicinal product. Acceptable methods include: combined hormonal contraception (containing estrogen and progestogen), 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), hormone-releasing intrauterine system (IUS), male condom, bilateral tubal occlusion, partner vasectomy, or sexual abstinence.
10. Participants capable of complying with the dosing regimen.
11. Participants capable of recording symptoms and medication use in an electronic diary via a smartphone (preferably) or in a paper diary.
12. Participants with a 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.

Exclusion criteria 25

1. Participants who have received allergen immunotherapy with the study aeroallergens (Dermatophagoides pteronyssinus, Dermatophagoides farinae and Lepidoglyphus destructor) within the last 5 years, or who are currently receiving immunotherapy with any allergen.
2. Participants who have undergone any desensitization procedure (e.g. oral immunotherapy (OIT), milk or egg), except those who have been in the maintenance phase for at least 12 months.
3. Participants for whom allergen-specific immunotherapy is absolutely contraindicated, according to the criteria of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Subcommittee.
4. Participants with uncontrolled or partially controlled asthma. Asthma control will be assessed using the asthma control assessment questionnaire (ACQ-6).
5. Participants with a forced expiratory volume in 1 second (FEV₁) < 80%, with respect to the reference value despite pharmacological treatment. Results will be considered valid if obtained within 12 months prior to signing the informed consent form (see Section 9.2).
6. Participants with severe asthma, according to GEMA 5.5, (2) receiving Step 5 or Step 6 treatment.
7. Participants receiving treatment with β-blockers, except for those administered topically, or angiotensin-converting enzyme (ACE) inhibitors.
8. Participants receiving immunosuppressive drugs (excluding corticosteroids), except for topical formulations, or biological therapies.
9. Participants requiring regular treatment with systemic corticosteroids (oral or injectable) for the treatment of rhinitis/rhinoconjunctivitis and asthma. Regular use of topical, cutaneous, or inhaled corticosteroids for the treatment of the aforementioned conditions and atopic dermatitis is permitted.
10. Unstable participants who have experienced a respiratory tract infection and/or asthma exacerbation within the 4 weeks prior to the screening/baseline visit.
11. Participants with a history of chronic urticaria, severe anaphylaxis, or personal history of hereditary angioedema within the 2 years prior to the screening/baseline visit.
12. Participants with any condition in which the administration of adrenaline is contraindicated (e.g. hyperthyroidism, heart disease, or hypertension), according to the investigator’s judgment.
13. Participants with any other serious disease unrelated to rhinoconjunctivitis or asthma that may interfere with study treatment or follow-up (e.g. epilepsy or renal disease), according to the investigator’s judgment.
14. Participants with uncontrolled autoimmune diseases (e.g. thyroiditis or lupus), tumoral diseases, or immunodeficiencies.
15. Participants that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness.
16. Participants with a known allergy to any component of the investigational medicinal product, other than the study allergens.
17. Participants with lower respiratory tract diseases other than asthma, such as emphysema, bronchiectasis, or chronic obstructive pulmonary disease (COPD).
18. Use of medications that may interfere with skin prick test reactions (e.g. antihistamines) within the timeframes specified in the protocol (see Section 9.2).
19. Participants with any nasal condition (e.g. nasal polyps or non-allergic rhinitis) that could affect an adequate evaluation of efficacy and/or safety, according to the investigator’s judgment.
20. Participants requiring regular treatment with antihistamines and/or corticosteroids (systemic [oral or injectable], topical, cutaneous, or inhaled) for indications other than the relief of allergic rhinitis symptoms, except for temporary use (≤ 15 days) for conditions such as common colds.
21. Pregnant or breastfeeding women.
22. Participants who are immediate family members of the investigator.
23. Simultaneous participation in another clinical trial, or prior participation within 30 days before the screening/baseline visit.
24. Participants with a history of severe systemic allergic reactions, including reactions to foods, hymenoptera venom, medications, etc.
25. Participants with controlled or uncontrolled cancer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) assessed over 4 weeks after one year of treatment, recorded using the Participant´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*: o Total IgE o Specific IgE and IgG4 o Specific IgE/Total IgE ratio * Immunological parameters and allergen profiling (ALEX technique) will be carried out at Inmunotek or by an external laboratory contracted by the sponsor.
11. Allergen profiling (ALEX technique)
12. Asthma Quality of Life Questionnaire (AQLQ)
13. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
14. Asthma Control Questionnaire (ACQ-6)
15. Visual Analogue Scale (VAS)
16. Consumption of Health Resources
17. Safety parameters: o Overall rate and severity of adverse events (AEs) per administration and per subject. o 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

Raquel Caballero Valentín

Public contact point

Organisation

Inmunotek S.L.

Contact name

Raquel Caballero Valentín

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

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

Documents 15 files

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

Application history

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