Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense

NCT01425788 | Completed Phase 2

• 1 other identifier: OS-G-01
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhino-conjunctivitis

Keywords

Grass pollen induced allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Tolerability based on reporting of adverse events

  Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.

  An average of 42 days per subject

Secondary Outcomes (1)

• Subject satisfaction

  Measured at "End of treatment/end of trial Visit"

Study Arms (3)

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

Biological: Osiris Phleum pratense

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

Biological: Osiris Phleum pratense

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

Biological: Osiris Phleum pratense

Interventions

Osiris Phleum pratense BIOLOGICAL

Osiris Phleum pratense - Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Ergomed: collaborator
• ACM Pivotal Global Central Laboratory: collaborator
• Brecon Pharmaceuticals Ltd: collaborator

Study Sites (1)

Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi

Lodz, 90-153, Poland

Location

Study Officials

• Piotr Kuna, Prof.med

  Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

PL (1)