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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723254
• Other study ID #: B4901001
• Secondary ID: ANTI- IGE VACCIN
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2012
• Last updated: August 5, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• IGE-1
Intramuscular, multiple dose
• IGE-2
Intramuscular, multiple dose
• Saline
Saline (0.9% sodium chloride)

Locations

Country	Name	City	State
Canada	Diex Research Montreal Inc.	Montreal	Quebec
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario
Canada	Centre de Recherche Appliquee en Allergie de Quebec	Quebec
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local reactogenicity events	Frequency of local reactogenicity events	Within 14 days after dose	Yes
Primary	Systemic reactogenicity events	Frequency of systemic reactogenicity events	Within 14 days after dose	Yes
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	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.	Baseline up to Day 336	Yes
Primary	Number of Participants with abnormal safety laboratory findings	blood chemistry, hematology, coagulation, and urinalysis	Baseline up to Day 336	Yes
Secondary	Antibody titers against IgE	Antibody titers against IgE	Baseline up to Day 336	No

External Links

•   To obtain contact information for a study center near you, click here.