A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01723254
First received: November 5, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to assess the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis.


Condition Intervention Phase
Allergic Rhinitis
Biological: IGE-1
Biological: IGE-2
Biological: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-IgE Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Local reactogenicity events [ Time Frame: Within 14 days after dose ] [ Designated as safety issue: Yes ]
    Frequency of local reactogenicity events

  • Systemic reactogenicity events [ Time Frame: Within 14 days after dose ] [ Designated as safety issue: Yes ]
    Frequency of systemic reactogenicity events

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  • Number of Participants with abnormal safety laboratory findings [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: Yes ]
    blood chemistry, hematology, coagulation, and urinalysis


Secondary Outcome Measures:
  • Antibody titers against IgE [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: No ]
    Antibody titers against IgE


Estimated Enrollment: 189
Study Start Date: December 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06444753 Biological: IGE-1
Intramuscular, multiple dose
Experimental: PF-06444752 Biological: IGE-2
Intramuscular, multiple dose
Placebo Comparator: Placebo
Intramuscular
Biological: Saline
Saline (0.9% sodium chloride)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive,
  • Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1 KU/L to at least one of the following common allergens: dust mite (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may compromise their ability to safely participate in the study.
  • Evidence or history of clinically significant pulmonary disease (including allergic and non-allergic asthma, chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary fibrosis, pulmonary hypertension, or others).
  • Evidence or history of clinically significant autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, or others).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723254

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Canada, Ontario
Pfizer Investigational Site Recruiting
Ottawa, Ontario, Canada, K1Y 4G2
Canada, Quebec
Pfizer Investigational Site Recruiting
Montreal, Quebec, Canada, H4N 3C5
Pfizer Investigational Site Recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
Pfizer Investigational Site Recruiting
Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01723254     History of Changes
Other Study ID Numbers: B4901001
Study First Received: November 5, 2012
Last Updated: April 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Vaccines
Phase 1
Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014