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Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03334851
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE November 17, 2017
Estimated Primary Completion Date September 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with change from baseline in labboratory test results [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with clinically relevant changes from baseline in ECG parameters [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with infections [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with dose limiting adverse events [ Time Frame: Day 1 through approximately Day 112 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with change from baseline in laboratory test results [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with clinically relevant changes from baseline in ECG parameters [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with infections [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with dose limiting adverse events [ Time Frame: Day 1 through approximately Day 112 ]
Change History Complete list of historical versions of study NCT03334851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Change from baseline in the number of specific B cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Change from baseline in the number of specific T cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with anti-drug antibodies (ADA) to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with neutralizing antibodies to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Apparent Clearance (CL) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Plasma Decay Half-Life of PF-06835375 [ Time Frame: Day 1 to approximately Day 112 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Volume of Distribution at Steady State (Vss) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • AUCtau of PF-06835375 (dose normalized) [ Time Frame: Day 1 through approximately Day 112 ]
  • Average Concentration (Cav) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Mean residence of time for PF-06835375 [ Time Frame: Day 1 though approximately Day 112 ]
  • Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Change from baseline in the number of circulating B cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Change from baseline in the number of circulating follicular T-helper like cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with anti-drug antibodies (ADA) to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Number of participants with neutralizing antibodies to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Apparent Clearance (CL) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Plasma Decay Half-Life of PF-06835375 [ Time Frame: Day 1 to approximately Day 112 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Volume of Distribution at Steady State (Vss) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • AUCtau of PF-06835375 (dose normalized) [ Time Frame: Day 1 through approximately Day 112 ]
  • Average Concentration (Cav) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Mean residence of time for PF-06835375 [ Time Frame: Day 1 though approximately Day 112 ]
  • Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  • Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Official Title  ICMJE A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS
Brief Summary This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: PF-06835375
    Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
  • Drug: Placebo
    Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Study Arms  ICMJE
  • Experimental: Part A, Cohort 1
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 2
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 3
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 4
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 5
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 6
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 7
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 8
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 1
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 8, 2022
Estimated Primary Completion Date September 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR criteria with symptom duration at least 6 months and positive with Rheumatoid Factor and/or anti citrullinated peptide antibody
  • 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 central nervous system manifestations, systemic vasculitis or pleuro/pericarditis
  • Active lupus nephritis
  • Treatment with B cell depleting agents within 52 weeks prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03334851
Other Study ID Numbers  ICMJE C1131001
2017-003077-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP