Clinical trial NCT01470313: A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cutaneous Lupus Erythematosus
Keywords: Safety and tolerability
cutaneous lupus erythematosus
efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 16 Weeks
Secondary outcomes:
measure: 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)
timeFrame: 12 Weeks
measure: Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
timeFrame: 12 Weeks
measure: Measure changes in biomarkers
timeFrame: 12 weeks
measure: Assess health outcomes measures
timeFrame: 12 Weeks
measure: Evaluate the Pharmacokinetics of PD-0360324
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Oxford
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Gratiot
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Ducansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Rapid City
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Markham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chisinau
country: Moldova, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.