A Clinical Study to Evaluate the Effectiveness of Beltavac® with polymerized extract of grass pollen mixture in allergic rhinoconjunctivitis in patients with allergic rhinoconjunctivitis associated or not with asthma

Phase 1

• Conditions: allergic rhinoconjunctivitis caused due to exposure to pollen grasses; MedDRA version: 20.1Level: PTClassification code: 10048908Term: Seasonal allergy Class: 100000004870; Therapeutic area: Diseases [C] - Disorders of Environmental Origin [C21]; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2023-510033-28-00
• Lead Sponsor: Probelte Pharma S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Signed and dated Informed Consent Form a. by a legally competent participant, 2. Patients (males or females) aged from 18 to 65 years,Being in good physical and mental health, 4. Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007] at screening visit. Participants with laboratory values > grade 1 will require retesting. Upon normalization of the out-of-range value(s), the participant will be eligible), 5. Females with childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must be willing to use a highly effective method of contraception: a. Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. b. Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only. c. Intrauterine device (IUD); d. Intrauterine hormone-releasing system (IUS) e. Bilateral tubal occlusion f. Vasectomized partner (provided that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success) g. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository It should always be supplemented with the use of a spermicide. h. Sexual abstinence (Defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant). or females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.),, 6. Female participants with childbearing potential must have a negative pregnancy test in serum at visit 1 (before randomization), 7. Having the diagnosis of grass pollen allergy based on all the following criteria: a. A medical history of allergic rhinoconjunctivitis for grass pollen allergens for at least the previous two pollen seasons, b. A medical history of moderate to severe rhinitis for grass pollen allergens for at least the previous two pollen seasons (definition of allergy severity according to ARIA, see Figureg. Being treated with anti-allergic medication for at least the previous pollen season prior to enrolment. 8. For asthmatic participants: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2023), 9. FEV1 =80% of the participant’s reference value or Peak Expiratory Flow (PEF) =80% of the participants´ individual optimal value (for asthmatic participants only), 10. Willingness and ability to complete a PROGRASS Diary Patient App during the pollen season. 2, c. A positive skin prick test (Beltaprick Test®, SPT - wheal diameter =3 mm) to grass pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm, d. Spec

Exclusion Criteria

1. Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion, 2. Previous immunotherapy with grass pollen allergens within the last 5 years, 3. Ongoing immunotherapy with grass pollen allergens or any other allergens, 4. Participants with acute allergic rhinitis/rhinoconjunctivitis due to other environmental allergens during the study period, 5. Participants with a sensitization to other environmental allergens (i.e., other pollens, house dust mites, cat dander, dog dander or other perennial antigens) when they present relevant symptoms that can interferes with grasses pollen season or the CPT performance, 6. Being in any relationship or dependence with the Sponsor, CRO and/or Investigator, 7. Inability to understand instructions/study documents, 8. Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible), 9. History of severe systemic reactions and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc., 10. History of hypersensitivity to the excipients of the investigational product or placebo, 11. Mild persistent to severe persistent asthma partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2023, (26)) 12. Chronic asthma or emphysema,particularly with a forced expiratory volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value, 13. History of a respiratory tract infection and/or exacerbation of asthma within 2 weeks before the screening, 14. History of significant renal disease or chronic hepatic disease, 15. Malignant active disease (ongoing or within the five past years), 16. Severe autoimmune disease, 17. Immune defects including immunosuppression, immunopathies, 18. Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations, 19. Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion from one month before screening until the end of the trial,20. General inflammatory, severe acute or chronic inflammatory diseases, 21. Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc. 22. Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g., doxepin, amitriptyline, desipramine, imipramine, etc.), 23. Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents, 24. Intake of beta-blockers, 25. Active tuberculosis, 26. Having any contraindication for the use of adrenaline (including hyperthyroidism), 27. Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus, 28. Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method, 29. Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs before the screening visit (V0), as defined in the Table 6: Waiting period for screening; exception made for routine (previously prescribed) control medication for asthmatic participants,, 30. Clinically relevant laboratory valu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified