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

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NCT03334851

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Study Location
Fundacion de Investigacion de Diego
San Juan, , 00927, Puerto Rico
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Systemic Lupus Erythematosus, Rheumatoid ArthritisSafety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
NCT03334851
  1. San Juan,
  2. Anniston, Alabama
  3. Anniston, Alabama
  4. Beverly Hills, California
  5. La Jolla, California
  6. La Jolla, California
  7. Los Angeles, California
  8. Clearwater, Florida
  9. Clearwater, Florida
  10. DeLand, Florida
  11. Orlando, Florida
  12. South Miami, Florida
  13. South Miami, Florida
  14. Baltimore, Maryland
  15. Catonsville, Maryland
  16. Raleigh, North Carolina
  17. Duncansville, Pennsylvania
  18. Dallas, Texas
  19. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 April 8, 2021
Estimated Primary Completion Date April 8, 2021   (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 Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020

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