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

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ClinicalTrials.gov Identifier: NCT01470313
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 11, 2011
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: PD-0360324 Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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).



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 Weeks ]
  3. Measure changes in biomarkers [ Time Frame: 12 weeks ]
  4. Assess health outcomes measures [ Time Frame: 12 Weeks ]
  5. Evaluate the Pharmacokinetics of PD-0360324 [ Time Frame: 16 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470313


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470313     History of Changes
Other Study ID Numbers: A6261008
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Pfizer:
Safety and tolerability
cutaneous lupus erythematosus
efficacy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases