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

NCT ID: NCT02143583

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

Brief Summary

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.

Detailed 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).

Conditions

Birch Pollen Allergy

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

AllerT 100 μg

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

No interventions assigned to this group

AllerT 50 μg

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

No interventions assigned to this group

Placebo

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anergis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Framçois SPERTINI, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Allergiklinikken

Hellerup, Copenhagen, Denmark

Lungemedicinsk Forskningsafdeling

Aarhus, , Denmark

Klinisk Institute

Odense, , Denmark

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

Viktorija Vevere private practice of Allergology

Rēzekne, , Latvia

Center of examination and treatment of allergic diseases

Riga, , Latvia

Kaunas Clinics University Hospital

Kaunas, , Lithuania

Allergy Clinic JSC Perspektyvos

Vilnius, , Lithuania

Vilnius University Hospital

Vilnius, , Lithuania

Antakalnio affiliation of the Vilnius City Allergy Center

Vilnius, , Lithuania

SPZOZ Uniwersytecki Szpital Kliniczny - Allergology

Lodz, , Poland

Alergologii Centrum

Lodz, , Poland

Alergotest

Lublin, , Poland

Alergo-Med

Tarnów, , Poland

Centrum Alergologii IRMED

Warsaw, , Poland

Silesian Piasts University of Medicine in Wrocław

Wroclaw, , Poland

Aler-med

Wroclaw, , Poland

NZOZ Przychodnia Lekarska Hipokrates

Zabrze, , Poland

University hospital Skane

Lund, , Sweden

Orebro University Hospital

Örebro, , Sweden

Lungavdelningen, Vastmanlands

Västerås, , Sweden

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Denmark; France; Latvia; Lithuania; Poland; Sweden; Switzerland

Other Identifiers

2013-003881-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AN005T

Identifier Type: -

Identifier Source: org_study_id