CompletedPhase 2

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

Canada213 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 fo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT02271009

SponsorAnergis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

View on ClinicalTrials.gov More Allergic Rhino-Conjunctivitis trials