Summary

for people ages 18-70 (full criteria)
at UCSD
study started
estimated completion

Description

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.

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

Keywords

Systemic Lupus Erythematosus Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Lupus Erythematosus, Systemic

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD Perlman Ambulatory Clinic not yet accepting patients
    La Jolla California 92037 United States
  • Altman Clinical and Translational Research Institute not yet accepting patients
    La Jolla California 92037-0943 United States
  • Wallace Rheumatic Studies Center in progress, not accepting new patients
    Beverly Hills California 90211 United States
  • Prive aftercare in progress, not accepting new patients
    Los Angeles California 90048 United States
  • Rheumatology Associates accepting new patients
    North Hollywood California 91607 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03334851
Phase
Phase 1
Study Type
Interventional
Last Updated