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

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cutaneous Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01470313
Pfizer
Terminated
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

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Descriptive Information
Brief Title  ICMJE A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
Official Title  ICMJE 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)
Brief SummaryThis 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.
Detailed DescriptionThe 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Lupus Erythematosus
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • Experimental: PD-0360324
    Intervention: Drug: PD-0360324
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Masek-Hammerman K, Peeva E, Ahmad A, Menon S, Afsharvand M, Peng Qu R, Cheng JB, Syed J, Zhan Y, O'Neil SP, Pleasic-Williams S, Cox LA, Beidler D. Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus. Clin Exp Immunol. 2016 Feb;183(2):258-70. doi: 10.1111/cei.12705. Epub 2015 Nov 9.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 16, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2011)
48
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion DateNovember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Moldova, Republic of,   United States
Removed Location CountriesSingapore
 
Administrative Information
NCT Number  ICMJE NCT01470313
Other Study ID Numbers  ICMJE A6261008
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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