Phase 1
N=190
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01723254 ↗Enrolled (actual)
190
Serious AEs
1.1%
Results posted
Jul 2016
Primary outcome: Primary: Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination — 50.0; 9.5; 30.0; 15.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- IGE-1 (Biological); IGE-2 (Biological); Saline (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination |
50.0; 9.5; 30.0; 15.0; 20.0; 5.0 | — |
| PRIMARY Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination |
0; 0.0; 10.0; 20.0; 0.0; 5.0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs |
5; 18; 20; 20; 19; 19 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
5; 9; 12; 13; 13; 12 | — |
| SECONDARY Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 |
2002.8; 2002.8; 2002.8; 2002.8; 2002.8; 2002.8 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01723254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.