Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df

ConditionsRhinitis Rhinoconjunctivitis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age12-65

SponsorInmunotek S.L.

About this trial

The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are:

Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who have signed and dated Informed Consent Form (ICF).

Female or male aged 12 to 65 years, both included, at the time of signature of ICF.

Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022(2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Disqualifiers

Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy [OIT], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen.

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)

Asthmatic participants with forced expiratory volume in the first second (FEV1) <80% (following at least a 6-hour washout of short-acting beta2 agonists [SABA] and 12-hour washout of long-acting beta2 agonists [LABA]) despite pharmacological treatment by the time of enrolment.

Participants with uncontrolled asthma, according to GINA 2022,(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.

Trial design

Design model

Parallel

Treatments tested in this trial

Allergen Immunotherapy Extract
Biological/Vaccine
Sublingual spray, solution

Treatment groups

736 Participants

are divided into 2 treatment groups

Group A: ControlPlacebo comparator 1 intervention

Group B: Sublingual MM09Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score

The RCMS corresponds to the sum of Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/Rhinoconjunctivitis Medication Score (RMS). The daily RCSMS will be calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3) Higher scores mean a worse outcome.

Time frame

last 4 weeks of IMP treatment

Secondary outcomes

RSS : Rhinitis/Rhinoconjunctivitis Symptom Score

The RSS will correspond to the sum of the grade of the six Rhinitis Rhinoconjunctivitis symptoms score (SS) divided by six: RSS (0-3) = (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final RSS will range from 0 to 3. Each symptom will be graded 0-3 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).

Time frame

last 4 weeks of IMP treatment

RMS : Rhinitis/Rhinoconjunctivitis Medication Score

The rhinitis/rhinoconjunctivitis rescue medication will be provided to the participants with the instruction to use them according to a specific stepwise standardised procedure (See section 8.6.2): * 0= no medication. * 1= if symptoms occur, first take an oral antihistamine (desloratadine) with or without ocular antihistamine (olopatadine) * 2= if symptoms are insufficiently controlled, add intranasal corticosteroid (INS) with or without oral antihistamine (fluticasone furoate). * 3= if symptoms persist and are insufficiently controlled add an oral corticosteroid (OCS) (methylprednisolone) (with or without intranasal corticosteroid \[INS\] and antihistamine)

Time frame

last 4 weeks of IMP treatment

ASS : Asthma Symptom Score

The score is obtained by the collection on the occurrence of following asthma symptoms: * Cough * Wheezing * Shortness of breath or feeling of choking * Chest tightness Each asthma symptom will be graded 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 grades of the four asthma symptoms score (SS) divided by four: ASS (0-3) = (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3.

Time frame

last 4 weeks of IMP treatment

AMS: Asthma Medication Score

The AMS will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 (90) and GINA 2020 guidelines.(91) The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal." The steps of medication shown in the Figure 6 (above) correspond to the medication stepping of GEMA 5.0. In asthma participants AMS will be score as follows: * 0.5= SABA as needed. * 1= Low dose ICS with/without SABA as needed. * 1.5= Low dose ICS + LABA or medium dose ICS with/without SABA as needed. * 2= Medium dose ICS+LABA with/without SABA as needed. * 2.5= High dose ICS+LABA with/without SABA as needed. * 3= High dose ICS+LABA + systemic corticosteroids with/without SABA as needed. The AMS will correspond to the highest level of medication taken on a day. The score will range from 0 to 3.

Time frame

last 4 weeks of IMP treatment