Rhinitis, Allergic Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of HAL-MRE1 Subcutaneous Immunotherapy in Adult Subjects With Ragweed Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
The aim of this first-in-human phase I study is to assess the safety and tolerability of
HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced
allergic rhinitis/rhinoconjunctivitis with or without asthma.
The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses
of HAL-MRE1.
A chemically modified, aluminum hydroxide adsorbed ragweed extract (HAL-MRE1) for
subcutaneous administration was developed for the treatment of ragweed pollen-induced
allergic rhinitis/rhinoconjunctivitis (ARC) with or without asthma. The aim of this
first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1
subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced ARC with or
without asthma.
The study will consist of 3 staggered cohorts of 15 subjects each who are randomly assigned
to the active or placebo group in a 2:1 manner using block randomization.
A one month gap must be maintained between the end of the ragweed pollen peak season (2018)
and subject randomization into the study. The study has seasonal constraints; subjects with
concomitant tree and/or grass pollen allergies must complete study treatment before any
allergy symptoms due to tree and/or grass pollen exposure develop or start study treatment
after the symptoms caused by the tree and/or grass pollen exposure have disappeared.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02424539 -
A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
|
Phase 4 | |
| Completed |
NCT02486159 -
The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
|
N/A | |
| Completed |
NCT00770315 -
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)
|
Phase 3 | |
| Completed |
NCT00771160 -
MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)
|
Phase 3 | |
| Completed |
NCT00834119 -
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
|
Phase 4 | |
| Recruiting |
NCT04435990 -
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
|
Phase 3 | |
| Recruiting |
NCT05177744 -
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
|
||
| Recruiting |
NCT05621356 -
Monitoring Allergen Immunotherapy in Allergic Rhinitis
|
||
| Not yet recruiting |
NCT06330974 -
Allergy, Asthma, and Atopic Eczema in Finland
|
||
| Completed |
NCT04645979 -
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico
|
||
| Completed |
NCT05122143 -
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
|
N/A | |
| Completed |
NCT05901532 -
Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis
|
Phase 2 | |
| Terminated |
NCT02722083 -
Exploratory Study for Allergy Relief Onset
|
Phase 2 | |
| Recruiting |
NCT05656482 -
Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients
|
||
| Recruiting |
NCT04898283 -
Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
|
Phase 3 | |
| Recruiting |
NCT06436534 -
Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
|
N/A | |
| Recruiting |
NCT05922176 -
Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients With Allergic Rhinitis
|
||
| Completed |
NCT02679105 -
Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy
|
Phase 2/Phase 3 | |
| Completed |
NCT01104012 -
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
|
N/A | |
| Completed |
NCT03375775 -
Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
|
N/A |