Investigation of Efficacy and Safety of Ragweed MATAMPL, Pollinex-R and Placebo in Patients With Ragweed Allergy

NCT00110786 | Completed Phase 2

• 2 other identifiers: RagweedMATAMPL204P2DP05001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Ragweed MATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to ragweed 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 safety and efficacy of Ragweed MATAMPL will be assessed by exposing allergic subjects to Ragweed pollen in an environmental exposure chamber (EEC). Patient symptomatic response to pollen and patient quality of life in the EEC will be determined.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy; Ragweed; Environmental Exposure Chamber

Outcome Measures

Primary Outcomes (1)

• Assessment of the clinical efficacy of Ragweed MATAMPL versus placebo in reducing seasonal allergic rhinitis (SAR) symptoms caused by ragweed pollen in an Environmental Exposure Chamber (EEC) Model

Secondary Outcomes (4)

• Comparison of the efficacy of Pollinex-R (modified Ragweed Tyrosine adsorbate) versus placebo in reducing SAR symptoms caused by ragweed pollen in an EEC Model

• Assessment of the immunological response to Ragweed MATAMPL, Pollinex-R, versus placebo immunotherapy in patients with SAR

• Evaluation of the impact of Ragweed MATAMPL and Pollinex-R versus placebo on quality-of-life in patients with SAR using the Rhinoconjunctivitis Quality of Life Questionnaire for use in the Environmental Exposure Chamber (RQLQ-EEC)

• Assessment of the safety and tolerability of Ragweed MATAMPL and Pollinex-R versus placebo in patients with SAR

Interventions

Ragweed MATAMPL BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• at least a 2-year clinical history of seasonal allergic rhinitis
• allergy to a ragweed allergen, defined by positive case history and positive skin prick test
• Specific IgE for ragweed as documented by a radioallergosorbent test (RAST), or equivalent test, with class \>= 2
• minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure at both Visits 4 and 5.
• Patients must observe drug washout times listed in the protocol prior to Screening.
• Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile
• Females of childbearing potential should be using acceptable birth control methods
• Patients who are normally active and otherwise judged to be in good health
• 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
• Patients must be able to follow instructions

You may not qualify if:

• Symptomatic for allergic rhinitis or allergic conjunctivitis from allergy to grass or trees
• Symptomatic for significant perennial rhinitis
• Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications
• Concurrent use of any prohibited medication(s) or inadequate washout of medication
• Chronic or intermittent use of inhaled, oral, intramuscular, intravenous, or potent or super-potent topical corticosteroids
• Chronic use of long acting antihistamines and other concomitant medications that would affect assessment of the effectiveness of study drug(s)
• 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 the first Baseline EEC Visit
• Diagnosis of sinusitis within 30 days of the first Baseline EEC Visit
• Any ocular disorder (other than allergic conjunctivitis) which could interfere with the evaluation of the study medication
• Hypersensitivity to the study drug excipients
• 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
• nasal septal ulcers, nasal surgery or nasal trauma within 90 days of enrollment
• Clinical history of anaphylaxis
• Patients with contraindications for allergy vaccines

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

  Allied Research International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2005
• First Posted: May 16, 2005
• Study Start: May 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 17, 2010

Record last verified: 2009-09

Locations

CA (1)