A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

January 27, 2014 updated by: Pfizer

A Randomized, Subject And Investigator-Blinded (Sponsor-Open), Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Preliminary Efficacy Of Multiple Ascending Doses Of PD- 0360324 In Subjects With Active Cutaneous Lupus Erythematosus (CLE)

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The trial was terminated prematurely on Oct 15, 2013 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3P 1A8
        • Pfizer Investigational Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pfizer Investigational Site
      • Oxford, Alabama, United States, 36203
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90045
        • Pfizer Investigational Site
    • Florida
      • Orange Park, Florida, United States, 32073
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Pfizer Investigational Site
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
    • Pennsylvania
      • Ducansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Pfizer Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Pfizer Investigational Site
      • Rapid City, South Dakota, United States, 57701
        • Pfizer Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample.
  • Active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to 10.
  • Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.

Exclusion Criteria:

  • Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day 1.
  • Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections
  • Subjects with evidence of past or active tuberculosis
  • Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo is normal saline. The timing of placebo administration will depend of the dosing frequency of the cohort (either every other week for 3 months or every 4 weeks for 3 months).
EXPERIMENTAL: PD-0360324
Drug: PD-0360324
Subjects will receive PD-0360324 intravenously in 3 different cohorts. The cohorts will be evaluated in ascending fashion. The doses planned are 100 mg every other week for 3 months, 150 mg every other week for 3 months, and 200 mg every 4 weeks for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of PD- 0360324 will be assessed by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.
Time Frame: 16 Weeks
16 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of PD-0360324 based upon reduction of severity of symptoms as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time Frame: 12 Weeks
12 Weeks
Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time Frame: 12 Weeks
12 Weeks
Measure changes in biomarkers
Time Frame: 12 weeks
12 weeks
Assess health outcomes measures
Time Frame: 12 Weeks
12 Weeks
Evaluate the Pharmacokinetics of PD-0360324
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (ESTIMATE)

November 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6261008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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