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

NCT01470313 | Terminated Phase 1

• 1 other identifier: A6261008
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 19

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.

Conditions

Cutaneous Lupus Erythematosus

Keywords

Safety and tolerability; cutaneous lupus erythematosus; efficacy

Outcome Measures

Primary Outcomes (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.

  16 Weeks

Secondary Outcomes (5)

• 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)

  12 Weeks

• Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

  12 Weeks

• Measure changes in biomarkers

  12 weeks

• Assess health outcomes measures

  12 Weeks

• Evaluate the Pharmacokinetics of PD-0360324

  16 Weeks

Study Arms (2)

PD-0360324

EXPERIMENTAL

Drug: PD-0360324

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PD-0360324 DRUG

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.

PD-0360324

Placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Pfizer Investigational Site

Anniston, Alabama, 36207, United States

Location

Pfizer Investigational Site

Oxford, Alabama, 36203, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90045, United States

Location

Pfizer Investigational Site

Orange Park, Florida, 32073, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46256, United States

Location

Pfizer Investigational Site

Fort Gratiot, Michigan, 48059, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28210, United States

Location

Pfizer Investigational Site

Ducansville, Pennsylvania, 16635, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Pfizer Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

Pfizer Investigational Site

Rapid City, South Dakota, 57701, United States

Location

Pfizer Investigational Site

Rapid City, South Dakota, 57702, United States

Location

Pfizer Investigational Site

Jackson, Tennessee, 38305, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23507, United States

Location

Pfizer Investigational Site

Clarksburg, West Virginia, 26301, United States

Location

Pfizer Investigational Site

Markham, Ontario, L3P 1A8, Canada

Location

Pfizer Investigational Site

Chisinau, 2025, Moldova

Location

Related Publications (1)

• 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.

  PMID: 26376111 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

MO (1); CA (1); US (17)