Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Anergis

Status: Completed

Conditions: Birch Pollen Allergy

Study type: Observational

Funder types: Industry

Identifiers

NCT02143583

AN005T

2013-003881-15 (EudraCT Number)

Details and patient eligibility

About

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

Full description

Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).

Enrollment: 196 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any subject having been randomized in the AN004T trial and had received at least one injection
2. Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments

Exclusion criteria

1. Any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
2. Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
3. Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
4. Any subject not covered by medical insurance
5. Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
6. Any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
7. Any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period

Trial design

196 participants in 3 patient groups

AllerT 100 μg

Description:

patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T

AllerT 50 μg

Description:

patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T

Placebo

Description:

Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T