Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of Two Dosing Regimens of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Drug: 300 IR (4M); Drug: 300 IR (2M); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 633
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31400
    • DIDIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female outpatients aged 18 to 50 years
• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
• Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
• A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria:

• Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
• Asthma requiring treatment other than beta-2 inhaled agonists.
• Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 300 IR (4M); 300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season	Drug: 300 IR (4M); 300 IR grass pollen allergen extract tablet starting 4 months before the pollen season; Other Names: Sublingual immunotherapy tablet
Experimental: 300 IR (2M); 300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season	Drug: 300 IR (2M); 300 IR grass pollen allergen extract tablet starting 2 months before the pollen season; Other Names: Sublingual immunotherapy tablet
Placebo Comparator: Placebo; Placebo tablet	Drug: Placebo; Placebo tablet; Other Names: Sublingual placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Adjusted Symptom Score (AAdSS)	The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.	Pollen period (average of 33.8 days) of Year 3

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Principal Investigator: Alain DIDIER, MD, Pr, Hôpital Rangueil-Larrey, Toulouse, France

Publications and helpful links

General Publications

• Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, Melac M, Malling HJ. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol. 2011 Sep;128(3):559-66. doi: 10.1016/j.jaci.2011.06.022. Epub 2011 Jul 29.
• Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, Soulie S, Zeldin RK. Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy. 2013 May;43(5):568-77. doi: 10.1111/cea.12100.
• Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015 May 22;5:12. doi: 10.1186/s13601-015-0057-8. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 3, 2007
• First Submitted That Met QC Criteria: January 3, 2007
• First Posted (Estimate): January 4, 2007

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors
• Other Study ID Numbers: VO53.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No