NCT01425788CompletedPhase 2
Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Tolerability based on reporting of adverse events
Study Overview
Brief Summary
The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.
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 — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent obtained before entering the trial
- •Male or female >/= 18 years at visit 1
- •A clinically relevant history of grass pollen induced allergic rhinoconjunctivitis (moderate to severe) and having received symptomatic treatment during grass pollen season 2010 and 2011
- •Positive skin prick test response (wheal diameter >/= 3mm) to Phleum pratense
- •Positive specific IgE against Phleum pratense (>/= 0,70KUL / class 2)
- •Female subjects of childbearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive methods until Visit 4
- •Subjects willing and able to comply with trial protocol regimen
Exclusion Criteria
- •Subjects included in another protocol (treatment intervention and/or investigational medicine product) or having participated in another clinical trial within 30 days prior to visit 1
- •A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen (e.g. hazel, alder, birch, ash) to which the subject will be exposed during the 30-day treatment period.
- •A clinically relevant medical history of symptomatic perennial allergy to allergen(s) to which the subject is regularly exposed (e.g. cat, house dust mites).
- •Known sensitization (history of positive SPT) to food allergens with oral allergy syndrome
- •Uncontrolled asthma (in accordance with GINA guidelines) within the last 12 months
- •FEV < 60% of predicted within the last 12 months
- •Severe asthma exacerbation(s) within the last 12 months
- •A clinically relevant chronic disease (>/= 3 months) (e.g fibrosis, malignancy, type 1 diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency)
- •Malignancy or systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease or immune deficiency disease)
- •Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis or dental extraction at randomisation
- •Medical history of recurrent urticaria or atopic dermatitis during the last 2 years
- •Currently receiving treatment preventing the initiation of SIT (e.g. tricyclic antidepressants, mono amine oxidase inhibitors (MAOIs) and catechol-O-methyl transferase inhibitors (COMT inhibitors))
- •History of allergy, hypersensitivity, or intolerance to the excipients of the investigational medicinal product
- •Being immediate family of the investigator or trial staff, defined as the investigator's / staff's spouse, parent, grandparent, child or grandchild
- •History of drug induced (incl. immunotherapy) facial angioedema (including experience of Quincke oedema) or a family (parents or siblings) history of hereditary angioedema
- •Anticipated use of any prohibited medication within the specified time windows as defined in the protocol
- •Previous treatment by immunotherapy with grass pollen for more than one month within the last 5 years
- •Any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the trial evaluations or optimal participation
- •History of anaphylaxis with cardio respiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction)
Arms & Interventions
Osiris Phleum pratense - Group C
Active Comparator
Group C up-dosing schedule:
Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day
Intervention: Osiris Phleum pratense (Biological)
Osiris Phleum pratense - Group B
Active Comparator
Group B Up-dosing schedule:
Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day
Intervention: Osiris Phleum pratense (Biological)
Osiris Phleum pratense - Group A
Active Comparator
Group A up-dosing schedule from 1IR (index of Reactivity) /day to 240 IR/day in 11 days and thereafter 300 IR/day in 19 days.
Day 1-6: 1,2,4,6,8,10 IR/day Day 7-11: 30, 60, 120, 180, 240 IR/day Day 12-30: 300 IR/day
Intervention: Osiris Phleum pratense (Biological)
Outcomes
Primary Outcomes
Tolerability based on reporting of adverse events
Time Frame: An average of 42 days per subject
Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.
Secondary Outcomes
- Subject satisfaction(Measured at "End of treatment/end of trial Visit")
Investigators
Study Sites (1)
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