Compare Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in EEC

NCT02271009 | Completed Phase 2 DMC

• 1 other identifier: AN008T
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhino-Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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).

  The mean TRSS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge.

  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 (9)

• Individual Nasal Symptom Scores (NSS)

  from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge

• Individual NSS

  All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge

• The Global Evaluation of Treatment Efficacy Questionnaire

  Visit 9, after the last post-treatment EEC session.

• The Asthma Symptom Score (ASS)

  before entry in the EEC (time point =0) and then every 30 minutes up to 6 hours in the EEC (12 time points)

• The mean TRSS

  All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge

Other Outcomes (2)

• The change in Bet v 1 specific immunoglobulin (Ig)E and IgG4 and AllerT specific IgE and IgG4.

  Screening Day 166 upto Day 3, Day 0

• The change in Bet v 1 specific immunoglobulin (Ig)E and IgG4 and AllerT specific IgE and IgG4.

  Day 0, Day 84

Study Arms (4)

Placebo without Al(OH)3

PLACEBO COMPARATOR

Five (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection.

Drug: Placebo

AllerT (10 µg with Al(OH)3)

ACTIVE COMPARATOR

Five (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection.

Drug: AllerT

AllerT (25 µg with Al(OH)3)

ACTIVE COMPARATOR

Five (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection.

Drug: AllerT

AllerT (50 µg with Al(OH)3)

ACTIVE COMPARATOR

Five (5) SC injections over a two-month (8-week) period, according to the following schedule: * First three SC injections at weekly intervals. * Fourth SC injection two weeks after the third injection. * Fifth SC injection four weeks after the fourth injection.

Drug: AllerT

Interventions

AllerT DRUG

Ultrafast immunotherapy

Also known as: Continuous overlapping peptides

AllerT (10 µg with Al(OH)3); AllerT (25 µg with Al(OH)3); AllerT (50 µg with Al(OH)3)

Placebo DRUG

placebo control

Placebo without Al(OH)3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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 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).

Sponsors & Collaborators

• Anergis: lead
• Inflamax Research Incorporated: collaborator

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

CA (1)