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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT01470313

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Lupus Erythematosus	Drug: PD-0360324 Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, 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)

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

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. [16 Weeks]

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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Anniston	Alabama	United States	36207
2	Pfizer Investigational Site	Oxford	Alabama	United States	36203
3	Pfizer Investigational Site	Los Angeles	California	United States	90045
4	Pfizer Investigational Site	Orange Park	Florida	United States	32073
5	Pfizer Investigational Site	Chicago	Illinois	United States	60611
6	Pfizer Investigational Site	Indianapolis	Indiana	United States	46256
7	Pfizer Investigational Site	Fort Gratiot	Michigan	United States	48059
8	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
9	Pfizer Investigational Site	Ducansville	Pennsylvania	United States	16635
10	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19107
11	Pfizer Investigational Site	Wyomissing	Pennsylvania	United States	19610
12	Pfizer Investigational Site	Rapid City	South Dakota	United States	57701
13	Pfizer Investigational Site	Rapid City	South Dakota	United States	57702
14	Pfizer Investigational Site	Jackson	Tennessee	United States	38305
15	Pfizer Investigational Site	Dallas	Texas	United States	75246
16	Pfizer Investigational Site	Norfolk	Virginia	United States	23507
17	Pfizer Investigational Site	Clarksburg	West Virginia	United States	26301
18	Pfizer Investigational Site	Markham	Ontario	Canada	L3P 1A8
19	Pfizer Investigational Site	Chisinau		Moldova, Republic of	2025