Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
NCT ID: NCT03334851
Last Updated: 2023-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2017-11-17
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Part A, Cohort 1
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 2
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 3
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 4
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 5
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 6
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 7
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part A, Cohort 8
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, Cohort 1
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, Cohort 2
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, Cohort 3
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, Cohort 4
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, Cohort 5
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Part B, cohort 6
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Interventions
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PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Eligibility Criteria
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Inclusion Criteria
* Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC Classification Criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith antibodies
Exclusion Criteria
* Active lupus nephritis
* Treatment with B cell depleting agents within 52 weeks prior to screening
18 Years
70 Years
ALL
No
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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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
Prive aftercare
Los Angeles, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Private Practice of Robert W. Levin, MD
Clearwater, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Omega Research Maitland, LLC
Orlando, Florida, United States
Larkin Hospital
South Miami, Florida, United States
Qps Mra, Llc
South Miami, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
PAREXEL International - EPCU Baltimore
Baltimore, Maryland, United States
Rheumatology Express
Catonsville, Maryland, United States
Carolina Phase 1 Research, LLC
Raleigh, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
MPP Infusion Centers
Dallas, Texas, United States
Countries
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References
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Cohen S, Beebe JS, Chindalore V, Guan S, Hassan-Zahraee M, Saxena M, Xi L, Hyde C, Koride S, Levin R, Lubaczewski S, Salganik M, Sloan A, Stevens E, Peeva E, Vincent MS, Martin DA, Chu M. A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. Arthritis Res Ther. 2024 Jun 6;26(1):117. doi: 10.1186/s13075-024-03337-2.
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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2017-003077-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C1131001
Identifier Type: -
Identifier Source: org_study_id
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