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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 : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Rheumatoid Arthritis Drug: PF-06835375 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : June 3, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A, Cohort 1
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
 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.
Experimental: Part A, Cohort 2
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 3
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 4
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 5
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 6
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 7
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part A, Cohort 8
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
 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.
Experimental: Part B, Cohort 1
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
 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.
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.
 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.
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.
 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.
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 through approximately Day 112 ]
  2. Number of participants with change from baseline in labboratory test results [ Time Frame: Day 1 through approximately Day 112 ]
  3. Number of participants with clinically relevant changes from baseline in ECG parameters [ Time Frame: Day 1 through approximately Day 112 ]
  4. Number of participants with infections [ Time Frame: Day 1 through approximately Day 112 ]
  5. Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 through approximately Day 112 ]
  6. Number of participants with dose limiting adverse events [ Time Frame: Day 1 through approximately Day 112 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Number of participants with anti-drug antibodies (ADA) to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  4. 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 ]
  5. Maximum Observed Plasma Concentration (Cmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  6. Number of participants with neutralizing antibodies to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  7. Apparent Clearance (CL) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  8. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  9. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  10. Plasma Decay Half-Life of PF-06835375 [ Time Frame: Day 1 to approximately Day 112 ]
  11. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  12. Volume of Distribution at Steady State (Vss) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  13. AUCtau of PF-06835375 (dose normalized) [ Time Frame: Day 1 through approximately Day 112 ]
  14. Average Concentration (Cav) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  15. Mean residence of time for PF-06835375 [ Time Frame: Day 1 though approximately Day 112 ]
  16. Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
  17. Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334851


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Alabama
Pinnacle Research Group, LLC Recruiting
Anniston, Alabama, United States, 36201
Pinnacle Research Group, LLC Recruiting
Anniston, Alabama, United States, 36207
United States, California
Wallace Rheumatic Studies Center Active, not recruiting
Beverly Hills, California, United States, 90211
California Clinical Trials Medical Group Managed by PAREXEL Recruiting
Glendale, California, United States, 91206
Inpatient Pharmacy Recruiting
Glendale, California, United States, 91206
PAREXEL International attn. Pharmacy Recruiting
Glendale, California, United States, 91206
Altman Clinical and Translational Research Institute Not yet recruiting
La Jolla, California, United States, 92037-0943
UCSD Perlman Ambulatory Clinic Not yet recruiting
La Jolla, California, United States, 92037
Prive aftercare Active, not recruiting
Los Angeles, California, United States, 90048
Rheumatology Associates Recruiting
North Hollywood, California, United States, 91607
Dan T. La, MD Recruiting
Tujunga, California, United States, 91042
United States, Florida
Clinical Research of West Florida, Inc. Recruiting
Clearwater, Florida, United States, 33765
Private Practice of Robert W. Levin, MD Recruiting
Clearwater, Florida, United States, 33765
Avail Clinical Research Recruiting
DeLand, Florida, United States, 32720
Omega Research Maitland Recruiting
Orlando, Florida, United States, 32810
Qps Mra, Llc Recruiting
South Miami, Florida, United States, 33143
Qps-Mra, Llc Recruiting
South Miami, Florida, United States, 33143
United States, Maryland
PAREXEL International - EPCU Baltimore Recruiting
Baltimore, Maryland, United States, 21225
Rheumatology Express Recruiting
Catonsville, Maryland, United States, 21228
United States, North Carolina
Carolina Phase 1 Research, LLC Not yet recruiting
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03334851     History of Changes
Other Study ID Numbers: C1131001
2017-003077-34 ( EudraCT Number )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases