Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due t… (NCT07348302) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Argentina736 participantsStarted 2025-04-02
Plain-language summary
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.
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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 have a serum pregnancy test negative result, and a confirmed menstrual period before enrolling the study.
✓. Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 month after the end of treatment with the investigational medicinal product (IMP). 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, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
What they're measuring
1
RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score
✓. Participants capable of complying with dosage regimen.
✓. Participants owning a smartphone to register symptoms and medication consumption.
Exclusion criteria
✕. 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.
✕. Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
✕. Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
✕. Participants on treatment with immunosuppressive or biological drugs.
✕. Participants who had not had a long enough washout/withdrawal period at the first screening visit (S1) according to criteria in the study protocol (See Table 6 in section 9.5.3) before undergoing allergen diagnostic tests (skin prick test or IgE analysis).