Allergic Rhinoconjunctivitis Clinical Trial
Official title:
Grass Pollen Sublingual Tablet Immunotherapy Plus Dupilumab for Induction of Tolerance in Adults With Moderate to Severe Seasonal Allergic Rhinitis (ITN084AD)
The primary objective of this study is to assess whether the combination of grass allergen sublingual immunotherapy (SLIT) and dupilumab for 2 years is more effective than double placebo in suppressing the nasal allergen challenge (NAC) response to grass pollen at 1 year after completion of study medication.
This is a double-blind (masked) placebo-controlled trial in adults (N=108 subjects will be enrolled) with moderate to severe seasonal allergic rhinitis and allergic sensitization to grass pollen. Eligible participants who demonstrate a positive response defined by a Total Nasal Symptom Score [TNSS] ≥ 5 (Scale 0-12 in response to a Nasal Allergen Challenge [NAC] with grass pollen extract), will be randomized to one of the following 3 groups in a 1:1:1 ratio: - Grass allergen sublingual immunotherapy (SLIT) + dupilumab (n=36) - Grass allergen SLIT +dupilumab placebo (n=36) - Grass allergen SLIT placebo + dupilumab placebo (n=36) Grazax® is a sublingual grass allergen immunotherapy product approved for clinical use in the United Kingdom and will be used as SLIT in this study. Grazax (and its matching placebo) will be self-administered daily by participants for a duration of two years. Dupixent®is the brand name for dupilumab and is a monoclonal antibody against the interleukin 4 (IL-4) receptor. Dupilumab (and its matching placebo) will be administered every two weeks by subcutaneous injection through for a duration of two years, administered by study personnel. The treatment phase of two years will be followed by an observation phase of 1 year. ;
| 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 |
NCT02437786 -
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
|
Phase 4 | |
| Completed |
NCT00985296 -
Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)
|
N/A | |
| 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 |
NCT01466465 -
Vitamin D and Grass Pollen Specific Immunotherapy
|
Phase 2 | |
| Completed |
NCT01567306 -
Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
|
Phase 2 | |
| Completed |
NCT01490411 -
Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis
|
Phase 2 | |
| Completed |
NCT00777374 -
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration
|
Phase 2 |