Allergic Rhinoconjunctivitis Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With rBet v1-FV Compared to Placebo in Birch Pollen-Allergic Patients With IgE-Mediated Seasonal Allergic Rhinoconjunctivitis
The purpose of this study is to find out if rBet v1-FV works to relieve Seasonal Allergic Rhinitis symptoms compared to Placebo (an inactive substance that looks like rBet v1-FV and also contains Aluminum Hydroxide but does not contain the experimental drug). rBet v1-FV is a vaccine that works by exposing your immune system to something that resembles birch. This vaccine may help to lessen your allergy symptoms during the natural birch season.
Type I allergy is an immune-disorder which stems from the formation of IgE antibodies
against proteins and glycoproteins from plants, insects, animals and fungi, most of which
are normally considered harmless. The cross-linking of specific IgE antibodies on effector
cells by allergens activates an immunological cascade leading to the symptoms of Type I
allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic
Rhinitis is the most common chronic atopic disease and is associated with considerable cost
and co-morbidity. Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses
and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and
pruritic, watery, red eyes.
Recombinant preparations offer various advantages over those based on natural allergen
extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical
quality; proteins are molecularly defined thus ensuring product consistency and minimising
problems related to allergen extract standardisation; preparations only include those
proteins that are considered relevant for specific immunotherapy; the risk of contamination
with other allergenic material is excluded; the whole production process can be designed to
exclude any risk factors for the introduction of infectious agents; the relative dosages of
individual components of a final preparation can be optimised to favour better clinical
efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by
altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and
decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance
beneficial immune responses. The investigational product has demonstrated efficacy and good
tolerability in one previous pivotal Phase III and two previous Phase II studies.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03850626 -
Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
|
||
Completed |
NCT03682965 -
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
|
Phase 2 | |
Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
Completed |
NCT01966224 -
A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects
|
Phase 1 | |
Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
Completed |
NCT01438463 -
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
|
Phase 2 | |
Completed |
NCT01438827 -
Avanz Phleum Pratense Maintenance Dose
|
Phase 2/Phase 3 | |
Completed |
NCT00985296 -
Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)
|
N/A | |
Completed |
NCT02437786 -
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
|
Phase 4 | |
Completed |
NCT01740284 -
A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
|
Phase 3 | |
Completed |
NCT04912076 -
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
|
Phase 1 | |
Completed |
NCT03365648 -
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
|
N/A | |
Completed |
NCT05455749 -
Effect of holoBLG on Cat Allergic Patients
|
N/A | |
Completed |
NCT01707069 -
A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid
|
Phase 1 | |
Completed |
NCT01567306 -
Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
|
Phase 2 | |
Completed |
NCT01466465 -
Vitamin D and Grass Pollen Specific Immunotherapy
|
Phase 2 | |
Completed |
NCT00777374 -
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration
|
Phase 2 | |
Active, not recruiting |
NCT04502966 -
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
|
Phase 2 |