SUBLIVAC FIX Birch Phase III Short-term Efficacy

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2016
• Main ID: NCT02231307
• Date of registration: 25/08/2014
• Prospective Registration: Yes
• Primary sponsor: HAL Allergy
• Public title: SUBLIVAC FIX Birch Phase III Short-term Efficacy
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Clinical Efficacy and Safety of SUBLIVAC FIX Birch Immunotherapy in Patients Suffering From Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen.
• Date of first enrolment: September 2014
• Target sample size: 406
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02231307
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Germany, Poland, Slovakia

Contacts

• Name: Oliver Pfaar, Prof. Dr.
• Affiliation: Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent

- Age = 18 and =65 years

- Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based
on ARIA classification for at least 2 consecutive years

- FEV1 (forced expiratory volume at one second) > 70% (of predicted value) for patients
with a history of asthma, FEV1 > 70% or PEF (peak expiratory flow) > 80% (of
predicted value) for patients without a history of asthma

- Positive SPT (skin prick test) for birch pollen (mean wheal diameter = 3mm compared
to negative control; negative control should be negative; histamine control should be
positive (mean wheal diameter = 3mm)) assessed during screening.

- Serum specific anti-birch IgE (immunoglobulin E) concentration >0.7 U/ml

- Patients should be willing and capable to complete an e-diary daily during the birch
pollen season (= 60% compliance in completion between Visit 1 and 2).

- A positive Nasal Provocation Test to birch pollen at Visit 2 (Lebel score = 6) or a
documented positive test within 1 year before start of treatment

Exclusion Criteria:

- Patients sensitized and symptomatic to pets should not be included if they are
regularly exposed to pets

- Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen
within the last 5 years

- SPT positive (mean wheal diameter = 3mm compared to negative control; negative
control should be negative; histamine control should be positive (mean wheal diameter
= 3mm)) patients to allergen(s) other than birch pollen, in the absence of a negative
provocation test for this allergen(s) (within 1 year), who are expected to have
clinically relevant symptoms during the birch pollen season

- Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last
5 years

- (Ongoing) allergen-specific immunotherapy (SCIT or SLIT) with any allergen(s) during
the study period

- Vaccination one week before start of treatment and/or during the up-dosing phase

- Treatment with experimental products within the last 3 months or biologicals
(including anti-IgE or TNF (tumor necrosis factor) - a treatment) within the last 6
months or during the study

- Uncontrolled asthma or other active respiratory diseases

- Clinically significant chronic sinusitis, ocular infection or severe inflammation of
the oral mucosa

- Severe immune disorders (including auto-immune diseases) and/or diseases requiring
immunosuppressive drugs

- Active malignancies or any malignant disease in the last 5 years

- Acute or chronic disease that in the opinion of the investigator is an additional
risk for the patients, including but not limited to the following: cardiovascular
insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically
significant renal or hepatic diseases, or haematological disorders

- Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism,
glaucoma)

- Use of systemic corticosteroids 4 weeks before the study

- Treatment with systemic or local ß-blockers

- Known hypersensitivity to any of the excipients (Disodium phosphate dihydrate, Sodium
dihydrogen phosphate dehydrate, aminocaproic acid, Peppermint oil, Caramel Colorant
or Glycerol)

- A positive urine pregnancy test, lactation or inadequate contraceptive methods
(adequate methods: oral contraceptives, IUD (intrauterine device), condom use and
having no sexual relationship with a man)

- Alcohol-, drug or medication abuse

- Lack of co-operation or compliance

- Severe psychiatric, psychological, or neurological disorders

- Any physical or mental condition that precludes administration or allergen-specific
immunotherapy, compliance or participation in a clinical trial

- Patients who are employees of the department, 1st grade relatives, or partners of the
investigator

- Patients who have planned holidays outside the country for more than 7 continuous
days during the defined pollen season (1st of March till 31st of May)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Birch Pollen Induced Rhinitis/Rhinoconjunctivitis

Intervention(s)

Drug: SUBLIVAC FIX Birch

Primary Outcome(s)

combined symptom medication score [Time Frame: 3 months]

Secondary Outcome(s)

(serious) adverse events [Time Frame: up to 9 months]

Quality of Life questionnaires [Time Frame: 3 months]

Serum specific immunoglobulin levels [Time Frame: up to 9 months]

urinalysis [Time Frame: up to 9 months]

symptom score [Time Frame: 3 months]

medication score [Time Frame: up to 3 months]

blood safety parameters [Time Frame: up to 9 months]

local and systemic reactions [Time Frame: up to 9 months]

Secondary ID(s)

SB/0042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors