Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense

ALK-Abelló

Status and phase

Completed

Phase 2

Conditions

Rhino-conjunctivitis

Treatments

Biological: Osiris Phleum pratense

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01425788

OS-G-01

Details and patient eligibility

About

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.

Enrollment

236 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

236 participants in 3 patient groups

Osiris Phleum pratense - Group A

Active Comparator group

Description:

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

Treatment:

Biological: Osiris Phleum pratense

Osiris Phleum pratense - Group B

Active Comparator group

Description:

Group B Up-dosing schedule: Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day

Treatment:

Biological: Osiris Phleum pratense

Osiris Phleum pratense - Group C

Active Comparator group

Description:

Group C up-dosing schedule: Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day