NCT02231307
Completed
Phase 3
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.
HAL Allergy39 sites in 5 countries406 target enrollmentStarted: September 2014Last updated:
InterventionsSUBLIVAC FIX Birch
DrugsSUBLIVAC FIX Birch
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- HAL Allergy
- Enrollment
- 406
- Locations
- 39
- Primary Endpoint
- combined symptom medication score
Overview
Brief Summary
The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in reducing birch allergy induced symptoms and birch allergy medication usage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) - α 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
Arms & Interventions
SUBLIVAC FIX Birch 0 AUN/ml
Placebo Comparator
Intervention: SUBLIVAC FIX Birch (Drug)
SUBLIVAC FIX Birch 40,000 AUN/ml
Experimental
Intervention: SUBLIVAC FIX Birch (Drug)
Outcomes
Primary Outcomes
combined symptom medication score
Time Frame: 3 months
Secondary Outcomes
- symptom score(3 months)
- Quality of Life questionnaires(3 months)
- Serum specific immunoglobulin levels(up to 9 months)
- local and systemic reactions(up to 9 months)
- (serious) adverse events(up to 9 months)
- blood safety parameters(up to 9 months)
- urinalysis(up to 9 months)
- medication score(up to 3 months)
Investigators
Study Sites (39)
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