A randomised, double-blind, placebo-controlled, multi-centre, multi-national Phase II / III follow-up study to assess long-term efficacy and safety of three different dose regimens of Oralgen® Grass Pollen in patients with grass pollen related allergic rhinoconjunctivitis (follow-up study to AB0602). - NA

Phase 1

• Conditions: Allergic rhinoconjunctivitis; MedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis

• Registration Number: EUCTR2007-002477-31-SK
• Lead Sponsor: Artu Biologicals Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-11
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. Patients who successfully completed study AB0602 up to visit 10.
2. Patients who have been informed of the nature and aims of the study and have given their written consent / assent to participate in this study in accordance with local laws and requirements.
3. Patients who are willing to comply with the protocol and understand the information given and the text of the consent form.
4. Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method (for example, hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with male condom, bilateral tubal ligation, diaphragm used with spermicide, female condom, monogamous relationship with vasectomised partner).
5. Negative urine pregnancy test if female at visit 10 of the previous study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. For patients meeting any of the exclusion criteria of study AB0602, the sponsor needs to be consulted before inclusion.
2. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
3. Patients who were non-compliant during study AB0602.
4. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified