Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
NCT ID: NCT02743871
Last Updated: 2022-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
97 participants
INTERVENTIONAL
2016-04-27
2021-03-09
Brief Summary
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Detailed Description
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The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.
The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
10 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 2
30 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 3
100 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Cohort 4
300 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 5
1000 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 6
2000 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 7
30 mg subcutaneous dose of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 subcutaneously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 subcutaneously
Cohort 8
300 mg of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 9
IV dose to be determined of PF-06817024 or placebo
PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
Cohort 10
PF-06817024 or placebo
PF-06817024
Subjects will be given 2 doses intravenously
Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Cohort 11
PF-06817024 or placebo
PF-06817024
Subjects will be given 2 doses intravenously
Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Cohort 12
PF-06817024 or placebo
PF-06817024
Subjects will be given 2 doses intravenously
Placebo for PF-06817024
Subjects will be given 2 doses intravenously
Cohort 13
PF-06817024 or placebo
PF-06817024
Subjects will be given doses of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given doses of Placebo intravenously
Interventions
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PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
PF-06817024
Subjects will be given one dose of PF-06817024 subcutaneously
Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 subcutaneously
PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
PF-06817024
Subjects will be given 2 doses intravenously
Placebo for PF-06817024
Subjects will be given 2 doses intravenously
PF-06817024
Subjects will be given doses of PF-06817024 intravenously
Placebo for PF-06817024
Subjects will be given doses of Placebo intravenously
Eligibility Criteria
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Inclusion Criteria
* Male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (Part 2)
* Male or female subjects between the ages of 18 and 75 years, inclusive with moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (Part 3)
Exclusion Criteria
* History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part 2)
* Exposure to live or attenuated vaccines, have skin conditions other than Atopic Dermatitis, use of JAK inhibitors and biologics (Part 3)
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UC Davis Dermatology
Sacramento, California, United States
UC Davis CTSC Clinical Research Center
Sacramento, California, United States
UC Davis Health
Sacramento, California, United States
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Academic Dermatology
Edina, Minnesota, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Ear, Nose & Throat Specialty Care of Minnesota, P.A.
Minneapolis, Minnesota, United States
Prism Research, LLC
Saint Paul, Minnesota, United States
Hassman Research Institute
Berlin, New Jersey, United States
Carolina Phase 1 Research, LLC
Raleigh, North Carolina, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Health Concepts
Rapid City, South Dakota, United States
Lee Medical Associates, PA
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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References
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Danto SI, Tsamandouras N, Reddy P, Gilbert SA, Mancuso JY, Page K, Beebe JS, Peeva E, Vincent MS. Exploratory pharmacodynamics and efficacy of PF-06817024 in a Phase 1 study of patients with chronic rhinosinusitis and atopic dermatitis. Allergy Asthma Clin Immunol. 2024 Aug 30;20(1):46. doi: 10.1186/s13223-024-00894-8.
Danto SI, Tsamandouras N, Reddy P, Gilbert S, Mancuso J, Page K, Peeva E, Vincent MS, Beebe JS. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-06817024 in Healthy Participants, Participants with Chronic Rhinosinusitis with Nasal Polyps, and Participants with Atopic Dermatitis: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Pharmacol. 2024 May;64(5):529-543. doi: 10.1002/jcph.2360. Epub 2023 Oct 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C0341001
Identifier Type: -
Identifier Source: org_study_id
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