Status:
COMPLETED
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Biomay AG
Conditions:
Birch Pollen Allergy
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The aim of this clinical phase I single centre, randomized, double-blind, placebo-controlled study with open comparator is to investigate tolerability and safety as well as the immunological effects o...
Detailed Description
Please see original article.
Eligibility Criteria
Inclusion
- Signed informed consent
- Age ≥18 ≤ 65 years
- Moderate to severe birch-pollen-induced allergic rhinitis/rhinoconjunctivitis of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see the manual of procedures) with or without concomitant mild to moderate persistent asthma
- Forced expiratory volume (FEV1) \>70% for patients with a history of asthma, FEV1\>70% or peak flow (PEF) \>80% for patients without a history of asthma
- A positive skin prick test (SPT) (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization
- Specific IgE against birch pollen extract ≥ 0.7 kU/L and against Bet v 1 ≥ 0.35 kU/L as determined by ImmunoCAP
Exclusion
- Chronic asthma with an FEV1\<70 % of predicted value.
- History of allergen immunotherapy (AIT) (subcutaneous (SCIT) or sublingual (SLIT)) with birch pollen or tree pollen mix including birch pollen within the past 5 years
- Ongoing AIT (SCIT or SLIT) with any allergen(s) during the study period
- Vaccination within one week before or during the treatment phase.
- Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy) within the last six months prior to inclusion and up to end of trial (EoT).
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
- Uncontrolled asthma or other active respiratory diseases.
- Active malignancies or any malignant disease during the previous 5 years.
- Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders.
- Renal insufficiency
- Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study.
- Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
- Use of systemic steroids within 4 weeks before start of the study and during the study.
- Treatment with systemic and local β-blockers.
- Known allergy towards constituents of the vaccine
- Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection). It is also accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile, or if they use both condom and diaphragm, The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the study.
- Alcohol, drug or medication abuse within the past year.
- Any clinically significant abnormal laboratory parameter at screening.
- Lack of cooperation or compliance.
- Any physical or mental condition that precludes administration of SCIT, compliance or participation in a clinical trial.
- Patients who are students or employees of the institution or 1st grade relatives or partners of the investigators
- Participation in a clinical trial within 3 months prior to the current trial.
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04912076
Start Date
September 17 2018
End Date
March 22 2019
Last Update
December 11 2023
Active Locations (1)
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1
Odense Research Center for Anaphylaxis, Odense University Hospital
Odense, Denmark, 5000