Clinical trial NCT02271009: Compare Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in EEC
Official title: A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhino-Conjunctivitis
Lead sponsor: Anergis
Sponsor class: INDUSTRY
Collaborators: name: Inflamax Research Incorporated
First posted: 2014-10-22
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find the optimal dose of AllerT that should be used to treat moderate to severe allergies due to birch tree pollen.

There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at different doses and 1 treatment group will receive placebo.

This study will also assess the effectiveness and safety of AllerT compared to placebo in relieving allergy symptoms.

Detailed description: Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an environmental exposure chamber (EEC).

Secondary Objectives:

* To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC.
* To assess the safety and tolerability of a two month treatment with three dose regiments of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3).
* To explore the immunological response to AllerT.

Eligibility criteria: Inclusion Criteria:

* Minimum two-year history of moderate to severe rhino-conjunctivitis on exposure to birch pollen with a need to take symptomatic medications (antihistamine, steroid) during pollen season, prior to study enrollment.
* Sensitivity to birch tree pollen confirmed at Screening by both of the following criteria:
* Positive Skin Prick Test (SPT) to birch pollen extract (wheal ≥ 3 mm than the negative control). Negative control must be ≤ 2 mm.
* Positive specific IgE CAP test for Bet v 1 (≥ 0.7 kU/L).
* A qualifying score in at least one of the two Baseline EEC Challenges: at least one diary card of 12/24 or greater for Total Rhinoconjunctivitis Symptom Score (TRSS) as well as either one diary card 6/12 or greater for Total Nasal Symptom Score (TNSS) or Total Ocular Symptom Score (TOSS).

Exclusion Criteria:

* Positive SPT to AllerT (wheal ≥ 3 mm than the negative control).
* Received specific immunotherapy against:

  * Any allergen within three years before the Screening visit.
  * Birch tree pollen or a tree pollen mix including birch pollen at any time before the Screening visit.
* Clinically significant symptoms due to allergens other than birch pollen during the EEC challenge periods (eg, perennial allergies, allergies to other pollens with overlapping allergy seasons during the EEC periods).
* Persistent un-controlled asthma; subjects with a Forced Expiratory Volume (FEV1) lower than 80% of their predicted value and/or subjects under chronic treatment for asthma with regular use of inhaled steroids. Subjects with seasonal asthma may be included. Subjects who require the occasional use of inhaled broncho-dilator can be included.
* History of birch pollen induced asthma. Note: A diagnosis of isolated exercise induced bronchospasm or controlled asthma (Global Initiative for Asthma \[GINA\] Step 1) not triggered by birch pollen does not constitute an exclusion criterion.
* History of documented severe anaphylactic reaction (Grade 4 of World Allergy Organization \[WAO\]).
* History of sinus disease including:

  * Acute or significant chronic sinusitis.
  * History of significant recurrent acute sinusitis, defined as two episodes per year for the last two years, all of which required antibiotic treatment.
  * History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes two or more major factors or one major factor and two minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
* Subjects who cannot tolerate the Baseline EEC Challenge or do not meet the Baseline EEC Challenge inclusion criteria.
* Subjects with a history of immunodeficiency or any other conditions that might affect the subject's safety or interpretation of study results.
* Received immunosuppressive medication (including oral corticosteroids) within four weeks prior to Screening, or planned to be used during the trial period.
* Received systemic or local antihistamines, oral or inhaled corticosteroids or under antidepressant medication with antihistamine effects within two weeks prior to Screening.
* Subjects for whom administration of epinephrine is contraindicated (eg, subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* Subjects being treated with beta-blockers in any form including topical ocular beta-blocker type medication.

Primary outcomes:
measure: The change in average Total Rhinoconjunctivitis Symptom Scores (TRSS) from the Baseline EEC Challenge (Visit 1 & Visit 2) to the Post-Treatment EEC Challenge (PTC) (Visit 8 & Visit 9).
timeFrame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
Secondary outcomes:
measure: Individual Nasal Symptom Scores (NSS)
timeFrame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
measure: Individual NSS
timeFrame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
measure: The Global Evaluation of Treatment Efficacy Questionnaire
timeFrame: Visit 9, after the last post-treatment EEC session.
measure: The Asthma Symptom Score (ASS)
timeFrame: before entry in the EEC (time point =0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
measure: The mean TRSS
timeFrame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
measure: The mean TNSS
timeFrame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
measure: The mean TOSS
timeFrame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
measure: The mean Total Nasal Symptom Scores (TNSS)
timeFrame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
measure: Total Ocular Symptom Score (TOSS)
timeFrame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
Other outcomes:
measure: The change in Bet v 1 specific immunoglobulin (Ig)E and IgG4 and AllerT specific IgE and IgG4.
timeFrame: Screening Day 166 upto Day 3, Day 0
measure: The change in Bet v 1 specific immunoglobulin (Ig)E and IgG4 and AllerT specific IgE and IgG4.
timeFrame: Day 0, Day 84
Locations:
city: Mississauga
country: Canada
facility: Inflamax Research Inc.
state: Ontario
Study officials:
References: