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Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy

A Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC

NCT02556801•HAL Allergy

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo. The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.

Detailed Description

The current dose range finding study with SP has been designed to test three different concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000 AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the minimal effective dose of SP. The study will be conducted in the target population of seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system. The EEC system is a facility that has temporal uniformity of airborne allergen (pollen) exposure to subjects. Use of the EEC ensures exposure to relatively consistent levels of allergen. This facility has been used in a number of immunotherapy trials and is an improved challenge model of AR compared to the previously used nasal provocation test. Treatment duration of this study is extended to 10 months.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who signed informed consent.
•2. Subjects aged ≥18 and ≤65 years at signing of informed consent.
•3. Subjects with at least two-year clinical history of allergic rhinitis/rhinoconjunctivitis to grass pollen, with or without concomitant asthma (asthma must be controlled).
•4. Subjects with a forced expiratory volume at one second (FEV1) \>70% of the predicted value as measured during screening or documented within 1 year of study start.
•5. Subjects with a positive skin prick test (SPT) (mean wheal diameter of at least 3 mm larger than the negative control; negative control should be \<2 mm, histamine control should be positive (mean wheal diameter of at least 3 mm larger than the negative control)) for grass pollen assessed during screening or a documented positive response obtained within 1 year before screening.
•6. Subjects with a grass pollen specific IgE greater than or equal to 0.7 kiloUnits (kU)/L assessed during screening or a documented positive result obtained within 1 year before screening.
•7. Subjects with a TSS of at least 10/24 during baseline EEC challenge (V2) in combination with a staff assessed score of at least 2/3 for two objective TSS symptoms (i.e. running nose, sneezing or red eyes), during the baseline EEC challenge.

Exclusion Criteria

•1. Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEC assessments at Visit 2 and Visit 6 due to concomitant sensitization i.e. positive SPT (mean wheal diameter of at least 3 mm larger than the negative control) and a history of allergic response to the causative allergen, at the discretion of the investigator.
•2. Patients with grass pollen induced asthma.
•3. Subjects who cannot tolerate the Baseline Challenge in the EEC.
•4. Subjects who received immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years.
•5. (Ongoing) allergen-specific immunotherapy with any allergen(s) during the study period.
•6. Subjects with unsuccessful allergen-specific immunotherapy within the past 5 years (e.g., but not limited to, prematurely stopped immunotherapy due to non-compliance, AEs or lack of therapeutic effect), at the discretion of the investigator.
•7. Subjects undergoing anti-IgE therapy within the 6 months prior to inclusion and/or during the study.
•8. Subjects suffering from severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
•9. Subjects suffering from active malignancies or any malignant disease (except for localized basal cell cancers of the skin as long as they have been adequately treated and no recurrence within 3 months of screening visit) during 5 years prior to screening.
•10. Subjects suffering from severe uncontrolled diseases that could increase the risk for participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders at the discretion of the Investigator.
+12 more criteria

Locations (1)

Inflamax Research Inc.

Mississauga, Canada

Key Dates

Start Date

September 1, 2015

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

September 13, 2019

Enrollment

168

ACTUAL participants

Conditions

Allergic RhinitisAllergic Rhinoconjunctivitis

Interventions

SUBLIVAC FIX Phleum Prat.

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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