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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470313
First received: November 9, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Cutaneous Lupus Erythematosus
Drug: PD-0360324
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Measure changes in biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assess health outcomes measures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Evaluate the Pharmacokinetics of PD-0360324 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, 57702
Pfizer Investigational Site
Rapid City, South Dakota, United States, 57701
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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470313     History of Changes
Other Study ID Numbers: A6261008
Study First Received: November 9, 2011
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014