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.
Brief Title
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Cutaneous Lupus Erythematosus
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Safety and tolerability
cutaneous lupus erythematosus
efficacy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
21 Years
NCT Id
NCT01470313
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
A6261008
Overall Status
Terminated
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome 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.
Outcome Time Frame
16 Weeks
Secondary Outcomes
Outcome Time Frame
12 Weeks
Outcome 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)
Outcome Time Frame
12 Weeks
Outcome Measure
Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Outcome Time Frame
12 weeks
Outcome Measure
Measure changes in biomarkers
Outcome Time Frame
12 Weeks
Outcome Measure
Assess health outcomes measures
Outcome Time Frame
16 Weeks
Outcome Measure
Evaluate the Pharmacokinetics of PD-0360324
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
steven.cohen@aya.yale.edu
Investigator Phone