A multi-national, randomised, double-blind, placebo-controlled, Phase II study to assess the efficacy and safety of three doses of sublingual immunotherapy administered as recombinant Bet v 1 tablets once daily to patients suffering from birch pollen rhinoconjunctivitis

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

• Registration Number: EUCTR2007-007869-21-DK
• Lead Sponsor: Stallergenes S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-12
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 492

Inclusion Criteria

The inclusion criteria are to be verified at Visit 1 (Screening) and reviewed at Visit 2 (Randomisation). Patients must meet all of the following inclusion criteria in order to participate in this study:
1.Male or female outpatients aged 18 to 65 years (inclusive).
2.Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
3.Sensitisation to birch pollen as demonstrated, at screening, by:
-A positive SPT to birch pollen with wheal diameter greater than 3 mm.
-Specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1).
4.Patients asymptomatic to all other allergens during the birch pollen season.
5.RRTSS during the previous pollen season = 12 out of a maximum possible score of 18.
6.Patients with an FEV1 = 80% of the predicted value.
7.Female patients with no childbearing potential. Female patients are considered not to have childbearing potential before their menarche, at least 2 years after menopause or if they have had a total hysterectomy, bilateral oophorectomy or ovariectomy.
8.Female patients of childbearing potential are eligible if they are not sexually active or if they:
-Use a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner), and
-Have a negative urine pregnancy test, and
-Are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study.
9.Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products.
10.Patients having provided signed informed consent before performing any study-related procedures.
11.Patients willing to comply with the protocol.
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

Exclusion Criteria:
The exclusion criteria are to be verified at Visit 1 (Screening) and reviewed at Visit 2 (Randomisation). Patients must not meet any of the following exclusion criteria in order to participate in this study:
1.Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
2.Patients with a history of drug or alcohol abuse.
3.Patients who have participated in any clinical trial within 3 months prior to this one.
4.Patients at risk of non-compliance.
5.Patients planning to move during the study.
6.Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
7.Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens.
8.Patients with symptomatic allergic rhinitis / rhinoconjunctivitis due to house dust mites.
9.Patients with symptomatic allergic rhinitis / rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
10.Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. (for example B. corylus [hazel], B. alnus [alder]) within the previous 10 years.
11.Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study).
12.Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polypsis or oral inflammation).
13.Patients with severe immune deficiency.
14.Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or outcome of this study. These diseases include, but are not limited to:
-cardiovascular disease - malignancy-hepatic disease-immunological disease
-renal disease or impairment-auto-immune disease-haematological disease-intercurrent infectious disease-neurological disease-endocrine disease
15.Any other disease or condition which would place a patient at undue risk by being included in the study (according to the investigator's opinion).
16.Known hypersensitivity to mannitol.
17.Usual contra-indications of immunotherapy such as:
-Concomitant local or systemic beta-blocker therapy and/or
-Immunosuppressive drugs.
18.Patients with ongoing treatment by immunotherapy with another allergen.
19.Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
20.Patients under continuous corticotherapy.
21.Patients undergoing chronic treatment with H2-antihistamine drugs.

Study & Design

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