Investigation of Efficacy and Safety of Tree MATAMPL,Tree MATA, and Placebo in Patients With Birch-Induced Seasonal Allergic Rhinitis

NCT00387478 | Terminated Phase 2

• 2 other identifiers: TreeMATAMPL204P2DP06002
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Tree MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to Tree (birch, alder, hazel) pollen (hay fever). This novel formulation is designed to provide a vaccine that will be efficacious with only four escalating dose injections administered before the start of the pollen season. In this Study the Efficacy will be assessed by exposing allergic subjects to birch pollen in an environmental exposure chamber EEC. Patient symptomatic response to birch pollen and patient quality of life in the EEC will be determined.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy; Tree; Environmental Exposure Chamber

Outcome Measures

Primary Outcomes (1)

• Assess the clinical efficacy as measured by Total Symptom Scores (TSS) of TreeMATAMPL versus placebo in reducing Allergic Rhinitis (AR) symptoms caused by birch tree pollen in an Environmental Exposure Chamber (EEC) Model.

  about 10 weeks

Secondary Outcomes (8)

• Assess the clinical efficacy of TreeMATAMPL versus placebo and TreeMATA in reducing AR symptoms caused by birch and oak tree pollen in an EEC model

  about 10 weeks

• Assess the responder/non-responder rate in TSS, NSS and NNSS of TreeMATAMPL versus placebo and TreeMATAMPL versus TreeMATA

  about 10 weeks

• Evaluate the correlation between TSS obtained during the baseline birch EEC session compared to baseline oak EEC session

  about 10 weeks

• Evaluate the correlation between the TSS change observed (baseline to post treatment) during the birch EEC sessions compared to oak EEC sessions

  about 10 weeks

• Assess the correlation between the percentage of positive skin prick test results between birch pollen and the following tree pollen: Oak, ash, red maple, poplar, black walnut, beech, sycamore and American elm

  during screening period (normally 1 day)

Study Arms (3)

1

EXPERIMENTAL

modified Tree pollen allergen absorbed to Tyrosine and containing MPL adjuvant

Biological: Tree MATA MPL or Tree MATA

2

EXPERIMENTAL

modified Tree pollen allergen absorbed to Tyrosine

Biological: Tree MATA MPL or Tree MATA

Placebo

PLACEBO COMPARATOR

4 injections of placebo 0.5 ml (2% tyrosine)

Biological: Tree MATA MPL or Tree MATA

Interventions

Tree MATA MPL or Tree MATA BIOLOGICAL

4 injections of increasing dose strength for Tree MATA MPL or Tree MATA: 1. 600 SU/0.5 ml 2. 1600 SU/0.5 ml 3. 4000 SU/0.5 ml 4. 4000 SU/0.6 ml 4 injections of 0.5 mL of 2% w/v L-tyrosine for Placebo

1; 2; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must be male or female and aged 18 to 50 years inclusive.
• Patients must have at least a two-year clinical history of SAR due to birch pollen allergy.
• Patients must have allergy to tree pollen allergen, defined by positive case history and positive skin prick test for tree pollen allergen (wheals of ≥ 5 mm (birch) and ≥ 3 mm (hazel and alder) greater than the negative control after skin prick testing) at Visit 1. Patients who will be skin tested at Visit 1 must adhere to the washout time for antihistamines.
• Specific IgE for birch tree pollen as documented by a radioallergosorbent test (RAST), or equivalent test, with class ≥ 2.
• Patients must obtain minimum qualifying symptom scores on the final two pre-treatment birch pollen exposure sessions (Visits 4 and 5) to be enrolled into the study. Minimum qualifying symptom scores are defined as a TSS of at least 12 out of a possible 24 and a NSS of at least 7 out of a possible 12 on at least one symptom diary card on each of Visits 4 and 5. Furthermore, a minimum priming criteria for NSS of 7 out of a possible 12, including a score of at least 2 for runny nose, on two diary cards during each of Visits 4 and 5, must be obtained.
• Patients must observe the drug washout times prior to Screening (Visit 1). The use of other medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for six weeks prior to Screening.
• Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea, or at least six weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential should be using one of the following acceptable birth control methods:Intrauterine device (IUD) in place for at least 3 months;Barrier method (condom or diaphragm) with spermicide; Stable hormonal contraceptive for at least 3 months prior to study and through study completion;Abstinence; Non-heterosexual lifestyle.
• Patients who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.
• Patients must be willing and able to give written informed consent and must provide this consent.
• Patients must be willing and able to attend required study visits. 11.Patients must be able to follow instructions.

You may not qualify if:

• A patient will not be included in this study if one or more of the following criteria apply:
• Have a positive skin prick test \[wheal (longest diameter) ≥ 3 mm greater than the negative control\] at Visit 1 to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chyrsogenum (notatum), and Aspergillus fumigatus), or epithelia (cat, dog, and horse). In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated.
• Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:
• Rhinitis medicamentosa; Large obstructive nasal polyps; Documented evidence of acute or significant chronic sinusitis, or upper respiratory tract infection as determined by the individual Investigator; Asthma, with the exception of mild intermittent asthma, to lessen confounding by asthma medications; History of hospitalization for asthma; History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
• Current diagnosis of seasonal asthma caused by tree pollen exposure.
• Concurrent use or inadequate washout of any prohibited medication.
• Chronic or intermittent use of inhaled, nasal, ocular, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids (as assessed by the Investigator).
• Chronic use of long acting antihistamines and other concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of study drug(s).
• Are pregnant or lactating.
• Any systemic disorder that could interfere with the evaluation of the study medication(s).
• Upper or lower respiratory infection requiring antibiotics within 14 days of Visit 2.
• Diagnosis of sinusitis within 30 days of Visit 2.
• Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication.
• Hypersensitivity to the study drug(s) excipients.
• Patients with active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections or parasitic or ocular herpes simplex.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Deepen Patel, MD, CCFP

  Allied Research International Inc, Mississauga, Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CA (1)