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

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)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470313

Enrollment

Registered

2011-11-11

Start date

2011-11-30

Completion date

2013-11-30

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Lupus Erythematosus

Keywords

Safety and tolerability, cutaneous lupus erythematosus, efficacy

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.

Interventions

DRUGPD-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.

DRUGPlacebo

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 design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada, Moldova, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026