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

Primary Purpose

Systemic Lupus Erythematosus, Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06835375
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group, LLC
  • Pinnacle Research Group, LLC
  • Wallace Rheumatic Studies Center
  • Prive aftercare
  • Clinical Research of West Florida, Inc.
  • Private Practice of Robert W. Levin, MD
  • Avail Clinical Research
  • Omega Research Maitland, LLC
  • Omega Research Maitland
  • Larkin Hospital
  • Qps Mra, Llc
  • Qps-Mra, Llc
  • PAREXEL International - EPCU Baltimore
  • Rheumatology Express
  • Carolina Phase 1 Research, LLC
  • Altoona Center for Clinical Research
  • Metroplex Clinical Research Center
  • MPP Infusion Centers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A, Cohort 1

Part A, Cohort 2

Part A, Cohort 3

Part A, Cohort 4

Part A, Cohort 5

Part A, Cohort 6

Part A, Cohort 7

Part A, Cohort 8

Part B, Cohort 1

Part B, Cohort 2

Part B, Cohort 3

Part B, Cohort 4

Part B, Cohort 5

Part B, cohort 6

Arm Description

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs) by seriousness and relationship to treatment
Number of participants with change from baseline in labboratory test results
Number of participants with clinically relevant changes from baseline in ECG parameters
Number of participants with infections
Number of participants with clinically relevant changes from baseline in vital signs
Number of participants with dose limiting adverse events

Secondary Outcome Measures

Change from baseline in the number of specific B cells (subset) over time following single and multiple doses of PF-06835375
Change from baseline in the number of specific T cells (subset) over time following single and multiple doses of PF-06835375
Number of participants with anti-drug antibodies (ADA) to PF-06835375
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06835375
Maximum Observed Plasma Concentration (Cmax) of PF-06835375
Number of participants with neutralizing antibodies to PF-06835375
Apparent Clearance (CL) of PF-06835375
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375
Plasma Decay Half-Life of PF-06835375
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375
Volume of Distribution at Steady State (Vss) of PF-06835375
AUCtau of PF-06835375 (dose normalized)
Average Concentration (Cav) of PF-06835375
Mean residence of time for PF-06835375
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375
Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375

Full Information

First Posted
November 3, 2017
Last Updated
April 6, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03334851
Brief Title
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A, Cohort 1
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
Arm Title
Part A, Cohort 2
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 3
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 4
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 5
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 6
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 7
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part A, Cohort 8
Arm Type
Experimental
Arm Description
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Arm Title
Part B, Cohort 1
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
Arm Title
Part B, Cohort 2
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Arm Title
Part B, Cohort 3
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Arm Title
Part B, Cohort 4
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Arm Title
Part B, Cohort 5
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Arm Title
Part B, cohort 6
Arm Type
Experimental
Arm Description
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Intervention Type
Drug
Intervention Name(s)
PF-06835375
Intervention Description
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs) by seriousness and relationship to treatment
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with change from baseline in labboratory test results
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with clinically relevant changes from baseline in ECG parameters
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with infections
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with clinically relevant changes from baseline in vital signs
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with dose limiting adverse events
Time Frame
Day 1 through approximately Day 112
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Number of participants with anti-drug antibodies (ADA) to PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
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
Title
Maximum Observed Plasma Concentration (Cmax) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Number of participants with neutralizing antibodies to PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Apparent Clearance (CL) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Plasma Decay Half-Life of PF-06835375
Time Frame
Day 1 to approximately Day 112
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Volume of Distribution at Steady State (Vss) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
AUCtau of PF-06835375 (dose normalized)
Time Frame
Day 1 through approximately Day 112
Title
Average Concentration (Cav) of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Mean residence of time for PF-06835375
Time Frame
Day 1 though approximately Day 112
Title
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375
Time Frame
Day 1 through approximately Day 112
Title
Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375
Time Frame
Day 1 through approximately Day 112

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Wallace Rheumatic Studies Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Prive aftercare
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Private Practice of Robert W. Levin, MD
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Omega Research Maitland, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Omega Research Maitland
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Larkin Hospital
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Qps Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
PAREXEL International - EPCU Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Rheumatology Express
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Carolina Phase 1 Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
MPP Infusion Centers
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1131001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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