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COMPLETED Phase 1

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

NCT03334851 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG PF-06835375

Study Locations (17)

Florida

  • Clinical Research of West Florida, Inc. — Clearwater
  • Private Practice of Robert W. Levin, MD — Clearwater
  • Avail Clinical Research — DeLand
  • Omega Research Maitland, LLC — Orlando
  • Larkin Hospital — South Miami
  • Qps Mra, Llc — South Miami
  • Qps-Mra, Llc — South Miami

Alabama

  • Pinnacle Research Group, LLC — Anniston
  • Pinnacle Research Group, LLC — Anniston

California

  • Wallace Rheumatic Studies Center — Beverly Hills
  • Prive aftercare — Los Angeles

Maryland

  • PAREXEL International - EPCU Baltimore — Baltimore
  • Rheumatology Express — Catonsville

Texas

  • Metroplex Clinical Research Center — Dallas
  • MPP Infusion Centers — Dallas

North Carolina

  • Carolina Phase 1 Research, LLC — Raleigh

Pennsylvania

  • Altoona Center for Clinical Research — Duncansville

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2017-11-17
Est. Completion 2022-02-15
Phase Phase 1

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03334851

The ClinicalTrials.gov registry entry for NCT03334851 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03334851 reports 17 study locations spanning 7 distinct geographic areas — top geographies include Florida, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03334851 about?

NCT03334851 is a clinical study titled "Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis". 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 ...

What is the current status of trial NCT03334851?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2017-11-17. Estimated completion is 2022-02-15.

What conditions does trial NCT03334851 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03334851?

The interventions under investigation include: Placebo (DRUG), PF-06835375 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03334851?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03334851 being conducted?

This trial has 17 study locations across Alabama, California, Florida, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial