Beltavac / Probelte Pharma - LARVOL DELTA

Subcutaneous House Dust Mite Immunotherapy Effectiveness and Safety in a Paediatric Population: A Prospective Real-Life Study. (PubMed, J Clin Med) - "To evaluate the effectiveness and safety of a glutaraldehyde-modified extract of mites (Beltavac®) administered for one year under clinical routine conditions in children between 3 and 11 years old...Over 90% of patients completed the full regimen. This study supports the effectiveness and safety of allergen immunotherapy administered according to a rush schedule for one year for paediatric allergic rhinitis."

Journal • Allergic Rhinitis • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of a house dust mites allergoid in patients with allergic rhinitis-PROACAROS study: protocol for a randomized controlled trial. (PubMed, Trials) - P3 | "This phase III clinical trial will be of interest to contribute to the scientific evidence about the efficacy and safety of AIT with allergoids. Our working hypothesis is that the investigational product in patients with AR associated or not with asthma is superior to placebo in providing a clinically significant improvement according to the standards defined by the EAACI. This trial will also supply valuable information about patients reported outcomes using health technology for rhinoconjunctivitis and asthma assessment."

Journal • Allergic Rhinitis • Allergy • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

PROACAROS: Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Probelte Pharma S.L.U. | Trial completion date: Feb 2024 ➔ Jun 2026 | Trial primary completion date: Feb 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Allergic Rhinitis • Allergy • Immunology • Inflammation

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites (clinicaltrials.gov) - P=N/A | N=97 | Completed | Sponsor: Alfons Malet i Casajuana | Active, not recruiting ➔ Completed

Trial completion • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander (clinicaltrials.gov) - P=N/A | N=34 | Completed | Sponsor: Probelte Pharma S.L.U. | Active, not recruiting ➔ Completed | N=50 ➔ 34 | Trial completion date: Oct 2023 ➔ Feb 2023 | Trial primary completion date: Jul 2023 ➔ Feb 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata (clinicaltrials.gov) - P=N/A | N=65 | Completed | Sponsor: Probelte Pharma S.L.U. | Active, not recruiting ➔ Completed | N=100 ➔ 65 | Trial completion date: Oct 2023 ➔ Jan 2023 | Trial primary completion date: Jul 2023 ➔ Jan 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Probelte Pharma S.L.U. | Trial completion date: Sep 2022 ➔ Oct 2023 | Trial primary completion date: Jun 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander (clinicaltrials.gov) - P=N/A | N=50 | Active, not recruiting | Sponsor: Probelte Pharma S.L.U. | Trial completion date: Oct 2022 ➔ Oct 2023 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites (clinicaltrials.gov) - P=N/A | N=97 | Active, not recruiting | Sponsor: Alfons Malet i Casajuana | Trial completion date: Jul 2022 ➔ Jul 2023 | Trial primary completion date: Jul 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

PROACAROS: Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Probelte Pharma S.L.U.

New P3 trial • Allergic Rhinitis • Allergy • Immunology • Inflammation

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Probelte Pharma S.L.U. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander (clinicaltrials.gov) - P=N/A | N=50 | Active, not recruiting | Sponsor: Probelte Pharma S.L.U. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites (clinicaltrials.gov) - P=N/A | N=97 | Active, not recruiting | Sponsor: Alfons Malet i Casajuana | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2021 ➔ Jul 2022 | Trial primary completion date: Mar 2021 ➔ Jul 2022

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: Probelte Pharma S.L.U.; Trial completion date: Oct 2021 ➔ Oct 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Inflammation • Ophthalmology • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata (clinicaltrials.gov) - P=N/A; N=100; Recruiting; Sponsor: Probelte Pharma S.L.U.; Trial completion date: Dec 2020 ➔ Sep 2022; Trial primary completion date: Nov 2020 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Conjunctivitis • Immunology • Ocular Inflammation • Ophthalmology • Respiratory Diseases

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander (clinicaltrials.gov) - P; N=50; Recruiting; Sponsor: Probelte Pharma S.L.U.

Clinical • New trial